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Leukemia - Chronic Lymphoblastic Leukemia
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Arzerra™ Approved for Refractory Chronic Lymphocytic Leukemia (11/2/2009)
The targeted therapy Arzerra™ (ofatumumab) has been granted accelerated approval by the U.S. Food and Drug Administration for treatment of patients with chronic lymphocytic leukemia (CLL) that is refractory to Fludara® (fludarabine) and Campath® (alemtuzumab).
Final Results Published of Randomized Trial of Treanda® Versus Chlorambucil for Initial Treatment of CLL (9/28/2009)
European researchers have published the final results of the randomized clinical trial showing a higher response rate and improved progression-free survival for Treanda® (bendamustine) compared with chlorambucil for the initial treatment of patients with Binet Stage B and C chronic lymphocytic leukemia (CLL). These results were published in the September 10, 2009 issue of the Journal of Clinical Oncology. Preliminary results of this study were presented at the 2007 and 2008 meetings of the American Society of Hematology.
Subcutaneous Campath Effective in Refractory CLL (9/16/2009)
Researchers from Germany have reported that, because of “efficacy, convenience, improved adverse effect profile and cost savings”, Campath® (alemtuzumab) given subcutaneously should be the treatment of choice for Fludara® (fludarabine)-refractory patients with chronic lymphocytic leukemia (CLL). The details of this study appeared early online in the Journal of Clinical Oncology on August 20, 2009.
Rituxan®, Fludara®, Cytoxan®, and Novantrone® Highly Active in CLL (9/10/2009)
Researchers from Spain have reported that the combination of Rituxan® (rituximab), Fludara® (fludarabine), Cytoxan® (cyclophosphamide), and Novantrone® (mitoxantrone) is highly active in patients with previously untreated chronic lymphocytic leukemia (CLL). The details of this study appeared in an early online publication on August 24, 2009 in the Journal of Clinical Oncology.
Ofatumumab Effective in CLL Patients Failing Rituxan® (6/2/2009)
Researchers involved in an international Phase II study have reported that ofatumumab, an anti-CD20 antibody, is effective in patients with chronic lymphocytic leukemia (CLL) who have previously received Rituxan® (rituximab). The details of this study were reported at the 2009 meeting of the American Society of Clinical Oncology on May 30, in Orlando, Florida.
Sequential Treatment with Fludara®, Cytoxan®, and Rituxan® Produces High-quality Responses in CLL (3/5/2009)
Researchers from the Sloan-Kettering Cancer Center have reported that patients with chronic lymphocytic leukemia (CLL) treated with Fludara® (fludarabine), followed by consolidation with Cytoxan® (cyclophosphamide), and finally consolidation with Rituxan® (rituximab) (F→C→R) achieved high-quality responses that improved with each phase of therapy. The details of this Phase II study were reported in the February 1, 2009 issue of the Journal of Clinical Oncology.
Low-dose Cytoxan® and Fludara® and High-dose Rituxan® Is Safe and Effective in Previously Untreated CLL (2/24/2009)
Researchers from the University of Pittsburgh have reported that reduced doses of Cytoxan® (cyclophosphamide) and Fludara® (fludarabine) combined with higher doses of Rituxan® (rituximab) in the FCR regimen is highly effective in previously untreated patients with chronic lymphocytic leukemia (CLL) and produces significantly less grade 3-4 neutropenia than standard FCR. The details of this study appeared in the February 1, 2009 issue of the Journal of Clinical Oncology.
Monoclonal B-Cell Lymphocytosis Precedes Development of CLL (2/18/2009)
Researchers from the National Cancer Institute have reported that monoclonal B-cell lymphocytosis (MBL) precedes the development of chronic lymphocytic leukemia (CLL). The details of this study appeared in the February 12, 2009 issue of the New England Journal of Medicine.
The American Society of Clinical Oncology 2008: Advances in Treatment of Lymphoma and Chronic Lymphocytic Leukemia (2/2/2009)
At the 2008 meeting of the American Society of Clinical Oncology (ASCO), there were more than 100 abstracts devoted to the treatment of lymphoma. There is increasing evidence that survival of patients with lymphoma and chronic lymphocytic leukemia (CLL) is steadily increasing. New drugs are being developed at a reasonable rate, which creates the question of how best to incorporate all the available drugs in an optimal manner. Additionally, there appears to be significant progress in reduced-intensity allogeneic stem cell transplants for low-grade lymphomas.
The American Society of Clinical Oncology 2008: Highlights of Treatment of Hematological Malignancies (1/30/2009)
The 2008 annual meeting of the American Society of Clinical Oncology (ASCO), held in Chicago, Illinois, again revealed advances in the treatment of hematologic malignancies. Patients with chronic or acute leukemias, myelodysplastic syndromes, and myeloproliferative disorders continue to be presented with novel, effective options for the treatment of their diseases.
Revlimid® Effective as First-line Therapy of CLL (1/8/2009)
On December 7, at the 2008 meeting of the American Society of Hematology in San Francisco, researchers presented two studies on the effectiveness of Revlimid® (linalidomide) for the initial treatment of patients with symptomatic chronic lymphocytic leukemia (CLL). These are the first reports of Revlimid treatment for newly diagnosed patients.
Flavopiridol Confirmed Active for Treatment of Relapsed CLL with Adverse Cytogenetics (1/2/2009)
Researchers from Ohio State University have reported that flavopiridol produces durable responses in patients with relapsed chronic lymphocytic leukemia (CLL) with high-risk cytogenetic abnormalities. The details of this study were presented at the 2008 meeting of the American Society of Hematology on December 7, 2008 in San Francisco.
Fostamatinib Disodium Effective for Diffuse B-Cell Lymphoma and CLL (12/17/2008)
Researcher involved in a U.S. multicenter trial have reported that the oral inhibitor of spleen tyrosine kinase (SYK), Fosamatinib disodium (FosD) (R788), has significant activity and is well tolerated in patients with diffuse large B cell lymphoma (DLBCL) and chronic lymphocytic leukemia (CLL). The results of this phase 1-2 study were reported in the Plenary Session of the 50th annual meeting of the American Society of Hematology on December 7, 2008 in San Francisco.
Treanda® and Rituxan® Effective for Relapsed CLL (12/10/2008)
Researchers affiliated with the German CLL Study Group have reported that Treanda® (bendamustine) and Rituxan® (rituximab) is an effective regimen for patients with relapsed chronic lymphocytic leukemia (CLL). The details of this study were presented at the annual meeting of the American Society of Hematology on December 8, 2008 in San Francisco.
Ofatumumab, a Human Anti-CD20 Monoclonal Antibody, Effecitive in CLL (12/10/2008)
Researchers involved in an International Phase II study have reported that Ofatumumab, a human Anti-CD20 monoclonal antibody, is effective for the treatment of patients with chronic lymphocytic leukemia (CLL) who have failed Fludara® (fludarabine) and Campath® (alemtuzumab) or who had failed Fludara and had bulky disease. The details of this study were presented at the annual meeting of the American Society of Hematology on December 8, 2008 in San Francisco.
Rituxan® and High-dose Methylprednisolone Effective Initial Treatment of CLL (12/9/2008)
Researchers from the University of California at San Diego (UCSD) have reported that the combination of Rituxan® (rituximab) and high-dose methylpredisolone is “an effective non-myelotoxic treatment regimen for patients with chronic lymphocytic leukemia (CLL).” The details of this Phase II study were presented at the annual meeting of the American Society of Hematology on December 7, 2008 in San Francisco.
Campath® and Rituxan® Promising for Untreated High-risk CLL (10/7/2008)
Researchers from the Mayo Clinic have reported that early treatment of asymptomatic patients with high-risk features of chronic lymphocytic leukemia (CLL) with Campath® (alemtuzumab) and Rituxan® (rituximab) appears promising. The details of this study appeared in the October 15, 2008 issue of Cancer.
Reduced-intensity Allogeneic Stem Cell Transplants Effective for Fludara® -resistant CLL (9/23/2008)
Researchers from the Fred Hutchinson Cancer Research Center have reported a five-year disease-free survival of 39% for patients with Fuldara® (fludarabine)-resistant chronic lymphocytic leukemia (CLL) treated with reduced-intensity allogeneic stem cell Transplantation. The details of this study appeared in an early online publication in the Journal of Clinical Oncology on September 15, 2008.
Genetic Characteristics of Hepatitis B Associated with Risk of Liver Cancer (9/2/2008)
Researchers from Taiwan have reported that different genetic characteristics of the hepatitis B virus (HBV) are associated with varying risks of developing hepatocellular carcinoma (HCC). These results were recently published in the August 20, 2008 issue of the Journal of the National Cancer Institute.
Long-term Results of Fludara®, Cytoxan®, and Rituxan® for CLL (7/29/2008)
Researchers from the M.D. Anderson Cancer Center have reported six-year follow-up data on 234 patients with chronic lymphocytic leukemia (CLL) treated with Fludara® (fludarabine), Cytoxan® (cyclophosphamide), and Rituxan® (rituximab) (FCR). The details of this study appeared in an early online publication in Blood on April 14, 2008.
Lumiliximab and FCR Promising for Relapsed CLL (6/26/2008)
Researchers from M.D. Anderson Cancer Center have reported that a regimen of lumilixmab, fludarabine, cyclophosphamide, and rituximab (L-FCR) is effective for the treatment of patients with relapsed CLL. The details of this Phase I/II study were presented at the 2008 meeting of the American Society of Clinical Oncology in Chicago May 30-June 2.
Flavopiridol Has Significant Activity in Relapsed Chronic Lymphocytic Leukemia (6/25/2008)
Researchers from Ohio State University have reported that flavopiridol has “pronounded” activity in treating patients with relapsed chronic lymphocytic leukemia (CLL). The details of this study were presented at the 2008 meeting of the American Society of Clinical Oncology in Chicago May 30-June 2.
Patients with Lymphoma and CLL Are at Increased Risk of Lung Cancer (6/20/2008)
Researchers from Wayne State University have reported that patients with Hodgkins lymphoma (HL), non-Hodgkins lymphoma (NHL), and chronic lymphocytic leukemia (CLL) have a 30-300% increased risk of developing lung cancer compared with controls without these diseases. The details of this study were reported at the 2008 meeting of the American Society of Clinical Oncology in Chicago, May 30-June 2.
Treanda® Approved by FDA for Initial Treatment of CLL (3/25/2008)
On March 20, 2008, the U.S. Food and Drug Administration (FDA) approved IV Treanda® (bendamustine) for initial treatment of chronic lymphocytic leukemia (CLL). The results were based on data from a randomized multicenter trial that were presented at the 2007 meeting of the American Society of Hematology (ASH), December 8-11, in Atlanta, Georgia.
Treanda® Approved by FDA for Initial Treatment of CLL (3/20/2008)
On March 20, 2008, the U.S. Food and Drug Administration (FDA) approved IV Treanda® (bendamustine) for initial treatment of chronic lymphocytic leukemia (CLL). The results were based on data from a randomized multicenter trial that were presented at the 2007 meeting of the American Society of Hematology (ASH), December 8-11, in Atlanta, Georgia.
Effectiveness of Reduced Intensity Allogeneic Stem Cell Transplants for Chronic Lymphocytic Leukemia (CLL) Confirmed (1/4/2008)
Researchers from the Fred Hutchinson Cancer Research Center (FHCRC) have presented long-term follow-up data showing that approximately 50% of patients receiving reduced intensity allogeneic stem cell transplants for advanced chronic lymphocytic leukemia (CLL) are alive at five years. This and another study presented at the 2007 meeting of the American Society of Hematology, December 8-11, in Atlanta, Georgia also showed that allogeneic stem cell transplantation was successful in patients with adverse cytogenetics.
Treanda™ Superior to Chlorambucil for Initial Treatment of Chronic Lymphocytic Leukemia (CLL) (1/3/2008)
Researchers from Germany have reported that Treanda (bendamustine) results in higher response rates and improved progression-free survivals in patients with previously untreated Binet stage B and C chronic lymphocytic leukemia (CLL) compared to chlorambucil. The results of this randomized trial were presented at the 2007 meeting of the American Society of Hematology (ASH), December 8-11, in Atlanta, Georgia.
Improved Response Duration with Leustat® (Cladaribine) Compared to Either Fludara® or Chlorambucil for CLL (1/3/2008)
An international randomized study has shown that Leustat (cladaribine, CdA) may be superior to Fludara and chlorambucil for the initial treatment of patients with chronic lymphocytic leukemia (CLL). This study was presented at the 2007 meeting of the American Society of Hematology, December 8-11, in Atlanta, Georgia.
Genasense® May Improve Survival of Patients with Chronic Lymphocytic Lekemia (CLL) Who Achieve a Complete Remission (12/28/2007)
Researchers involved in a multicenter trial have reported that the addition of Genasense® (oblimersen, Bcl-2 antisense) to Fludara® (fludarabine) and Cytoxan® (cyclophosphamide) improves the survival of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who achieve a complete remission (CR) or near complete remission (nCR). The details of this study were presented at the 2007 meeting of the American Society of Hematology (ASH) December 8-11, 2007 in Atlanta, Georgia.
Role of Mitoxantrone in Combination Therapy for Chronic Lymphocytic Leukemia (CLL) Evaluated (12/26/2007)
Researchers from Spain have reported preliminary results of initial treatment of patients with chronic lymphocytic leukemia (CLL) with a combination of Rituxan® (rituximab), Fludara® (fludarabine), Cytoxan® (cyclophosphamide) and Novantrone (mitoxantrone) (R-FCM). However, researchers from the MD Anderson Cancer Center question the utility of adding mitoxantrone to the combination Fludara, Cytoxan and Rituxan (FCR) regimen. These two studies were presented at the 2007 annual meeting of the American Society of Hematology.
Cytoxan®, Fludara®, Campath® and Rituxan® (CFAR) for High-Risk Chronic Lymphocytic Leukemia (CLL) (12/21/2007)
Researchers from the MD Anderson Cancer Center have reported that a regimen of Cytoxan (cyclophosphamide), Fludara (fludarabine), Campath (alemtuzumab) and Rituxan (rituximab) (CFAR) shows promising results for the treatment of high-risk chronic lymphocytic leukemia (CLL). This study was presented at an oral session of the 2007 meeting of the American Society of Hematology in Atlanta Georgia, December 8-11, 2007.
Prognostic Features of Early Stage Chronic Lymphocytic Leukemia (CLL) Defined (12/21/2007)
Researchers from Germany have reported that the thymidine kinase, lymphocyte doubling time, beta-2 microglobulin, absolute lymphocyte count, and age were predictors of overall survival (OS) for patients with chronic lymphocytic leukemia (CLL) with Binet stage A disease. This study was presented at the 2007 meeting of the American Society of Hematology in Atlanta, Georgia December 8-11, 2007.
Fludara® not Superior to Chlorambucil for CLL in the Elderly (12/18/2007)
Researchers affiliated with the German CLL Study Group have reported that elderly patients with chronic lymphocytic leukemia (CLL) have no significant clinical benefit from receiving first-line therapy with Fludara (fludarabine) compared to chlorambucil. This study was presented at the 2007 annual meeting of the American Society of Hematology in Atlanta, Georgia, December 8-11.
Campath® Superior to Chlorambucil for Initial Treatment of Chronic Lymphocytic Leukemia (12/10/2007)
European researchers involved in a randomized international trial (CAM-307) have reported that Campath® (alemtuzumab) was superior to chlorambucil for initial treatment of patients with chronic lymphocytic leukemia (CLL). The details of this study appeared in an early on-line publication on November 5, 2007 in the Journal of Clinical Oncology.
FDA Approves Campath® for First-Line Treatment of B-cell CLL (11/21/2007)
In October of 2007 the US Food and Drug Administration (FDA) approved Campath (alemtuzumab) for initial treatment for patients with chronic lymphocytic leukemia (CLL). This is the first monoclonal antibody approved by the FDA for B-cell CLL.
Umbilical Cord Blood Transplantation with Reduced Intensity Regimen Effective (11/14/2007)
Researchers from the University of Minnesota have reported that adults with hematological diseases have a three year survival of almost 50% following umbilical cord blood transplantation after a reduced intensity treatment regimen. The details of this study appeared in the October 15, 2007 issue of Blood.
Fludara® and Cytoxan® Confirmed Standard Initial Treatment for CLL (7/23/2007)
Researchers affiliated with the LRF CLL4 Trial have concluded that Fludara (fludarabine) and Cytoxan (cyclophosphamide) should be the standard treatment for chronic lymphocytic leukemia (CLL) and the basis for incorporation of monoclonal antibodies. The details of this study appeared in the July 21, 2007 issue of The Lancet.
Expanded Label Filed for Campath® (4/9/2007)
Gemzyme Corporation and Bayer HealthCare have submitted a supplemental biologics license application (sBLA) for their agent Campath® (alemtuzumab) to the United States Food and Drug Administration (FDA).
Genasense® Combination Therapy Effective for CLL (2/20/2007)
Researchers involved in a multicenter trial have reported that the addition of Genasense (oblimersen, Bcl-2 antisense) to Fludara® (fludarabine) and Cytoxan® (cyclophosphamide) improves the response rate and duration of response in relapsed or refractory chronic lymphocytic leukemia (CLL).
Lumiliximab Granted Orphan Drug Status and Fast Track Status (2/9/2007)
The United States Food and Drug Administration (FDA) has granted both orphan drug status and fast track status to Biogen Idec’s lumiliximab for the treatment of chronic lymphocytic leukemia (CLL).
Rituxan® and Campath® Show Significant Activity in Newly Diagnosed Poor Risk CLL (12/8/2006)
Dr. Steve Rosen from the Robert T. Lurie Comprehensive Cancer Center at Northwestern University has presented the preliminary results of a phase II study of Rituxan (rituximab) and Campath (alemtuzumab) for initial treatment of patients with poor risk chronic lymphocytic leukemia (CLL).
Campath® Safe and Active in Patients With CLL After Extensive Prior Therapy (11/15/2006)
Researchers from Austria have reported data that further confirms the efficacy and safety of Campath® (alemtuzumab) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have failed prior therapies.
Nipent®, Cytoxan® and Rituxan® Effective for Untreated Poor Risk CLL (10/30/2006)
Researchers from Ohio State University and the Mayo Clinic have reported that the treatment combination consisting of Nipent (pentostatin), Cytoxan (cyclophosphamide) and Rituxan (rituximab) (PCR) demonstrates high activity in previously untreated patients with chronic lymphocytic leukemia (CLL) with high-risk factors.
Reduced Intensity Allogeneic Stem Cell Transplantation in Fludara-Resistant CLL (6/22/2006)
Researchers from the Fred Hutchinson Cancer Research Center have reported updated outcomes of 64 patients with Fludara-refractory chronic lymphocytic leukemia (CLL) treated with reduced intensity allogeneic stem cell transplants. These data were presented at the 2006 annual meeting of the American Society of Clinical Oncology in June
Cytogenetic Correlation to Responses in Campath® (6/19/2006)
Researchers from several institutions in Europe have reported that specific cytogenetics in chronic lymphocytic leukemia (CLL) are associated with superior responses to Campath (alemtuzumab). These results may ultimately allow for highly individualized therapies including Campath. These results were reported at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO).
FCM-R Plus Neulasta® Highly Active in Previously Untreated CLL (6/15/2006)
Results from a phase II study have indicated that treatment including Fludara® (fludarabine), cyclophosphamide, Novantrone® (mitoxantrone), Rituxan® (rituximab) and Neulasta® (pegfilgrastrim) is highly active in symptomatic patients with chronic lymphocytic leukemia (CLL) who have not received prior therapy and who are 70 years or younger. These results were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO).
Modified Fludara®, Cyclophosphamide and Rituxan® Highly Effective with Fewer Side Effects for Untreated Chronic Lymphocytic Leukemia (6/14/2006)
Early results from a phase II study indicate that modified doses of Fludara (fludarabine), cyclophosphamide, and Rituxan (rituximab), referred to as mFCR, provide high activity with lower rates of neutropenia than standard FCR in untreated chronic lymphocytic leukemia. These results were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO).
Campath® Provides Superior Responses to Chlorambucil as First-Line Therapy in CLL (6/8/2006)
Interim results from an international phase III trial demonstrate that Campath (alemtuzumab) provides significantly superior responses with a favorable toxicity profile when compared with chlorambucil as initial therapy of B-cell chronic lymphocytic leukemia (CLL). These results were recently presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO).
Nipent®/Cytoxan®/Rituxan® Shows High Activity in Previously Treated CLL or Low-Grade NHL (4/6/2006)
Researchers from Memorial Sloan-Kettering Cancer Center have reported that Nipent (pentostatin), Cytoxan (cyclophosphamide) and Rituxan (rituximab) (PCR) has high activity in previously treated patients with chronic lymphocytic leukemia (CLL) or low-grade non-Hodgkin’s lymphoma (NHL).
Revlimid® Has Significant Activity in Chronic Lymphocytic Leukemia (1/25/2006)
Researchers from the Roswell Park Cancer Center and the Toronto Sunnybrook Regional Cancer Center have reported that Revlimid (lenalidomide) has significant activity in chronic lymphocytic leukemia (CLL).
Rituxan® Plus GM-CSF Safe and Effective for Chronic Lymphocytic Leukemia (1/12/2006)
Researchers from M.D. Anderson Cancer Center have reported that the combination of Rituxan (rituximab) and granulocyte macrophage-colony stimulating factor, Leukine®, (sargramostim) is well tolerated and very effective for previously untreated or treated patients with chronic lymphocytic leukemia (CLL).
Small Molecule Bcl-2 Protein Inhibitor, GX15-070, Active for Treatment of Refractory Chronic Lymphoid Leukemia (1/12/2006)
Researchers from M.D. Anderson Cancer Center, the University of California at San Diego, the Princess Margaret Hospital in Toronto and Georgetown University have reported that the anti-apoptotic molecule, GX15-070, is safe and biologically active for the treatment of refractory chronic lymphoid leukemia (CLL).
HuMax®-CD20 Safe and Effective Treatment for Relapsed/Refractory Chronic Lymphoid Leukemia (1/11/2006)
Researchers from several European medical centers have reported significant activity for the human monoclonal antibody, HuMax-CD20, for the treatment of patients with relapsed/refractory chronic lymphoid leukemia (CLL).
Nipent®/Cytoxan®/Rituxan® Shows High Activity in High-Risk Chronic Lymphocytic Leukemia (11/23/2005)
Researchers from Ohio State University and the Mayo Clinical have reported that the treatment combination consisting of Nipent (pentostatin), Cytoxan (cyclophosphamide) and Rituxan (rituximab) demonstrates high activity in previously untreated patients with chronic lymphocytic leukemia (CLL) with high-risk factors.
Fludara®, Cyclophosphamide and Rituxan® Active in Early and Late CLL (6/24/2005)
Researchers from M.D. Anderson Cancer Center have reported that a regimen of Fludara (fludarabine), cyclophosphamide, and Rituxan (rituximab) produces results superior to any previously tested for treatment of relapsed and refractory chronic lymphocytic leukemia (CLL).[1] They also reported that this regimen is very active for initial treatment of CLL.[2]
Reduced Intensity Allogeneic Stem Cell Transplants Effective for CLL (5/9/2005)
Researchers from the Fred Hutchinson Cancer Research Center and several other cooperating transplant centers have reported that reduced intensity allogeneic stem cell transplants were effective therapy for patients with advanced chronic lymphocytic leukemia (CLL).
Reduced Intensity Allogeneic Stem Cell Transplants Effective for Refractory CLL and Follicular Lymphoma (4/22/2005)
Researchers from Italy have reported that allogeneic stem cell transplantation using a reduced intensity regimen of thiotepa, fludarabine and cyclophosphamide results in high rate of complete clinical and molecular remissions in patients with relapsed or refractory chronic lymphocytic leukemia and follicular lymphoma.
ZAP-70 is a Strong Predictor for Progression of CLL (8/26/2004)
Researchers affiliated with the Chronic Lymphocytic Leukemia Research Consortium have reported that the presence of the abnormal protein, ZAP 70, is a stronger predictor of aggressive CLL than unmutated immunoglobulin heavy-chain variable region gene (IgVh). The details of this study appeared in the August 25, 2004 edition of the New England Journal of Medicine.
Early Treatment of Younger Patients with Aggressive CLL with Autologous Stem Cell Transplants Looks Promising (5/24/2004)
Two recent publications have evaluated high-dose chemotherapy with autologous peripheral blood stem cell transplantation for younger patients with aggressive chronic lymphocytic leukemia (CLL).
Addition of Rituxan® to Chemotherapy may be Superior to Chemotherapy Alone in CLL (12/19/2003)
While the overall impact of Rituxan® on improving progression-free and overall survival in CLL as compared to fludarabine monotherapy has not been tested in a randomized trial to date, analysis of phase II data shows that fludarabine plus Rituxan® appear to be superior to fludarabine chemotherapy alone. Furthermore, fludarabine and cyclophosphamide plus Rituxan® improves survival over historical treatments including fludarabine plus or minus prednisone and fludarabine/cyclophosphamide.
Gleevec® Treatment of Philadelphia Chromosome-Positive ALL Buys Time for Donor Search (12/12/2003)
Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) represents 40% of ALL cases in patients over the age of 40 years. For adults with Philadelphia chromosome-positive ALL, survival at 3 years does not exceed 20% in most studies. Most cooperative groups have ongoing studies designed to improve the outcome of such patients. Most studies are based on the observation that recipients of allogeneic transplant from related or unrelated donors have improved survivals and up to 40%-50% of patients are long-term survivors. The outcomes for autologous stem cell transplants have not been clearly superior to intensive consolidation therapy without stem cell support but may be improved for the subset that achieves PCR negativity allowing the collection of leukemia-free stem cells.
Arsenic Trioxide and ATRA Highly Effective for Remission Induction of APL (12/12/2003)
Chinese and French researchers have reported that the combination of all trans-retinoic acid (ATRA) and arsenic trioxide is a very effective induction regimen which improves disease-free survival for patients with acute promyelocytic leukemia (APL).
1 The results of a randomized trial comparing arsenic trioxide alone, ATRA alone or the combination of arsenic trioxide and ATRA suggests synergism between these two drugs. The results of this trial were presented at the 45th annual meeting of the American Society of Hematology in December of 2003.
Zarnestra™, a Farnesyl Transferase Inhibitor, Active in AML (12/10/2003)
Two multicenter US clinical trials have established Zarnestra™ as an active agent for the treatment of acute myeloid leukemia (AML). Zarnestra™ has been evaluated in patients with refractory AML
1 and in elderly or high-risk patients with untreated AML.
2 The results of these 2 phase II clinical trials were presented at the 45th annual meeting of the American Society of Hematology in December 2003.
Rituxan® and Campath® can be Safely Given Together with Encouraging Responses in Refractory Lymphoid Malignancies Expressing CD20 and CD52 (4/22/2003)
Researchers from the MD Anderson Cancer Center reported improved response rates in patients with refractory CLL or other B-cell malignancies that coexpressed CD20 and CD52 when treated with combined Rituxan® (rituximab) and (Campath®) alemtuzumab for the treatment of patients with refractory chronic lymphocytic leukemia (CLL) or other B-cell malignancies. These reported favorable results were reported in the May 1, 2003 issue of
Blood.
New Drug, Velcade", Shows Activity in Low-Grade Non-Hodgkin’s Lymphoma (12/19/2002)
Over the past decade several new agents have been introduced to treat patients with low-grade non-Hodgkin’s lymphoma (NHL) including: Fludara®, Rituxan®, Zevalin™ and Bexxar® resulting in significant prolongation of survival. Now, an additional class of agents, the proteasome inhibitors, also appears to be active in patients with low-grade NHL. Velcade" (bortezomide, PS-341) is the first proteasome inhibitor to reach phase I and II testing in clinical trials. Proteasomes appear to be important for degradation of regulatory proteins that govern cell cycle, transcription factor activation, apoptosis and cell trafficking. Preclinical and clinical data have confirmed that inhibitors of the proteasome can act through multiple mechanisms to arrest tumor growth, tumor spread and angiogenesis. Proteasome inhibits degradation of wild-type tumor suppressor protein p53 and inhibits activation of a key transcription factor, nuclear factor kB. In addition, proteasome overrides bcl-2 gene over-expression, leading to apoptosis. Velcade™ has a high specificity for inhibition of proteasome activity. In phase I trials, Velcade™ was tolerated and showed a dose-related effect on proteasome activity.
Concurrent Rituxan® with Fludara® Improves CR Rate in Chronic Lymphoid Leukemia (CLL) (12/18/2002)
Rituxan® is an anti-CD20 antibody that has been used therapeutically since 1998 and there are numerous publications documenting the effectiveness of this agent for the treatment of low-grade and aggressive NHL, CLL, mantle cell NHL, cutaneous B-cell lymphoma, EBV-associated lymphoma and autoimmune diseases of B cells. Most of the early studies involved the treatment of patients who had failed conventional chemotherapy or stem cell transplants. More recently there has been intense activity aimed at determining the optimal regimen and timing of Rituxan® for patients with CD20 positive B-cell malignancies. A recent report published in the January 2003 issue of Blood suggests that concurrent administration of Rituxan® and Fludara® is much more effective than sequential administration for treatment of CLL.
Bexxar™ Produces Long-Term Responses in Patients with Non-Hodgkins Lymphoma (12/15/2002)
Currently, there are two antibodies approved by the U.S. Food and Drug Administration (FDA) for malignancies of B cell lymphocytes. Rituxan®, an anti-CD20 antibody, has been approved for the treatment of patients with non-Hodgkin lymphoma (NHL) who have failed initial therapy. Campath®, an anti-CD52 antibody, has been approved for the treatment of patients with chronic lymphocytic leukemia (CLL) who have failed initial treatment. In addition, the FDA recently approved Zevalin™, which is essentially Rituxan® linked to 90Yttrium, for treatment of patients with NHL who have failed initial chemotherapy. An application for approval of Bexxar®, which is an anti-B cell antibody linked to iodine 131, is pending and will be reviewed by the FDA on December 17, 2002. There has been consternation about the approval of Zevalin™ and not Bexxar® by the FDA since both drugs appear to be very effective. At the 2002 meeting of the American Society of Hematology there were three important presentations which should help in the approval process for Bexxar®.
British Researchers Fail to Find Benefit From Allogeneic Stem Cell Transplant After Intensive Chemotherapy Induction and Consolidation for AML (12/13/2002)
The role of allogeneic stem cell transplants as consolidation therapy for patients with acute myeloid leukemia (AML) in first complete remission is changing due to the increased effectiveness of chemotherapy and the ability of cytogenetics to predict outcome. At the present time it is clear that patients with favorable cytogenetics (acute promyelocytic leukemia, t(8;21) and inv16) should not have an allogeneic stem cell transplant until after first relapse. This is because the results of chemotherapy consolidation are as good or better than for patients receiving an allogeneic stem cell transplant. In this setting, the transplant related mortality offsets the benefits of a lower relapse rate associated with allogeneic stem cell transplants. However, the benefits of allogeneic stem cell transplantation in first remission for those with intermediate or poor cytogenetics remains an open question.
Mylotarg® Followed by Allogeneic Stem Cell Transplantation is Effective Therapy for Patients with Relapsed Acute Myeloid Leukemia (12/11/2002)
Patients with acute myeloid leukemia who relapse after initial remission induction have a very poor survival. Approximately 30% of these patients can be induced into a second remission but the duration of remission is usually less than 6 months.
Mylotarg® is a monoclonal antibody linked to a toxin called calicheamycin. The monoclonal antibody is directed at CD33 which is present in 80-90% of AML cells but is not present on the normal hematopoietic stem cell. Thus, the antibody-toxin conjugate can selectively kill leukemia cells. The primary toxicity of this agent is veno-occlusive disease (VOD) of the liver, presumably because there are CD33 positive cells in the liver. Mylotarg® was approved by the U.S. Food and Drug Administration in 2000 for the treatment of patients with AML over the age of 60 who had failed initial treatment.
Rituxan® and Fludara®: An Effective Regimen for Chronic Lymphocytic Leukemia (10/24/2002)
The optimal treatment for patients with chronic lymphocytic leukemia remains to be determined. At the present time, the most active single agent is Fludara® (fludarabine). Initial treatment with Fludara® alone is associated with a 50-60% response rate, but all patients ultimately relapse. Rituxan® (rituximab) is an active agent for the treatment of patients with CLL who have recurrent disease but have not undergone extensive evaluation as initial therapy. Researchers in Germany have evaluated the combination of Fludara® and Rituxan® as initial therapy and for patients who have failed initial therapy in a phase II clinical trial. They reported their results in the November 1, 2002 issue of
Blood where they conclude that this combination of drugs is active and should be compared to Fludara® alone in a prospective randomized trial.
Non-Myeloablative Allogeneic Stem Cell Transplants Effective in Patients Who Fail Autologous Stem Cell Transplant (10/2/2002)
High-dose chemotherapy supported by autologous stem cell transplantation is the treatment of choice for selected patients with Hodgkin’s disease, non-Hodgkin’s lymphoma and multiple myeloma. However, the majority of patients treated with autologous stem cell transplants will ultimately relapse and treatment options are few. Myeloablative regimens followed by allogeneic stem cell transplants are associated with a high treatment-related mortality due to regimen-related toxicities and graft-versus-host disease. The recent development of non-myeloablative treatment regimens followed by allogeneic stem cell transplants has been associated with less early treatment-related mortality. Researchers in England have reported that this approach is successful in half the patients who have failed a previous autologous stem cell transplant. They reported their results in the October 2002 issue of the
Journal of Clinical Oncology.
Campath® Antibody Effective for Patients with Chronic Lymphocytic Leukemia (CLL) who Have Failed Fludara® (5/8/2002)
According to results recently published in
Blood, Campath® appears to produce significant responses in patients with CLL who have failed Fludara®.
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