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The U.S. Food and Drug Administration (FDA) has approved revised prescribing information and a Risk Evaluation and Mitigation Strategy (REMS) for ponatinib (Iclusig) that allows immediate resumption of its marketing and commercial distribution. The prescribing information includes a revised...
In a European Organisation for Research and Treatment of Cancer (EORTC) and Gruppo Italiano Malattie Ematologiche dell’ Adulto (GIMEMA) phase III trial (AML-12) reported in Journal of Clinical Oncology, Willemze et al compared induction regimens containing high-dose or standard-dose...
Nearly all of the patients with high-risk chronic lymphocytic leukemia (CLL) in a phase II clinical trial responded to treatment with the targeted therapy ibrutinib (Imbruvica) and the antibody rituximab (Rituxan), researchers reported at the 55th American Society of Hematology (ASH) Annual Meeting ...
The monoclonal antibody gemtuzumab ozogamicin (Mylotarg) improved event-free survival and reduced the risk of relapse in children with acute myeloid leukemia (AML) in a study from the Children’s Oncology Group, presented at the 55th American Society of Hematology (ASH) Annual Meeting and...
Two novel agents—the small-molecule PI3K inhibitor IPI-145 and the Bcl-2 inhibitor ABT-199—show promising activity in chronic lymphocytic leukemia (CLL), according to two phase I studies presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstracts...
Obinutuzumab (Gazyva) plus chlorambucil (Leukeran) was superior to rituximab (Rituximab) plus chlorambucil as first-line therapy in older chronic lymphocytic leukemia (CLL) patients with comorbidities, with an acceptable safety profile, according to final results of the phase III CLL11 trial....
Development of autologous genetically engineered anti-CD19 chimeric antigen receptor (CAR)-expressing T cells holds promise in the treatment of hematologic malignancies. CAR T cells are being studied in adult and pediatric acute lymphocytic leukemias and in chronic lymphocytic leukemia, and...
T-cell–depleted HLA-haploidentical hematopoietic stem cell transplantation can be made more efficacious and safer through the removal of alpha/beta-positive T cells and CD19-positive B cells from the graft, an approach pioneered by Italian investigators who reported results at the 55th...
Combining gemtuzumab ozogamicin (Mylotarg) with conventional chemotherapy may improve the outcome of bone marrow transplantation for some children battling high-risk acute myeloid leukemia (AML), according to a study led by St. Jude Children’s Research Hospital. The results appear in the...
In a study reported in the Journal of Clinical Oncology, Kevin R. Krill, PhD, and colleagues from St. Jude Children’s Research Hospital assessed neurocognitive function in adult survivors of childhood acute lymphoblastic leukemia (ALL). They found pervasive significant impairment across...
The Group for Research in Adult Acute Lymphoblastic Leukemia (GRAALL) recently reported significantly better outcome in T-cell acute lymphoblastic leukemia (ALL) harboring NOTCH1 or FBXW7 (N/F) mutations, although relapse was still observed in one-third of patients with N/F-mutated T-cell ALL. In a ...
On October 31, 2013, Ariad Pharmaceuticals, the manufacturer of ponatinib, agreed to an FDA request to suspend marketing and sales of the drug due to the risk of life-threatening blood clots and severe narrowing of blood vessels. The FDA states that it will continue to evaluate ponatinib to further ...
Preliminary results of an ongoing clinical trial suggest that the BRAF inhibitor vemurafenib (Zelboraf)—indicated for the treatment of metastatic melanoma with BRAF V600E mutation—may have an important role in the treatment of hairy cell leukemia. The cornerstone of therapy for this...
The U.S. Food and Drug Administration (FDA) today approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA...
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
In a phase III trial (EORTC [European Organisation for Research and Treatment of Cancer]/GIMEMA [Gruppo Italiano Malattie Ematologiche dell’Adulto] consortium AML-17 trial) reported in the Journal of Clinical Oncology, Sergio Amadori, MD, of Tor Vergata University Hospital in Rome, and...
The U.S. Food and Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking the antileukemia drug ponatinib (Iclusig). Ponatinib is indicated for the treatment of patients with...
Myeloablative conditioning with cyclophosphamide combined with intravenous busulfan (Busulfex) was associated with better leukemia-free and overall survival than conditioning with cyclosphosphamide and total-body irradiation in patients with acute myeloid leukemia (AML) who were in first complete...
In a study reported in Journal of Clinical Oncology, Raya Mawad, MD, of Fred Hutchinson Cancer Research Center, and colleagues assessed the frequency of allogeneic hematopoietic cell transplantation in patients with acute myeloid leukemia (AML) in first complete remission at their institution and...
Older patients with acute myeloid leukemia (AML) have a high relapse rate after standard chemotherapy. In a study reported in Journal of Clinical Oncology, Sylvie D. Freeman, MD, PhD, of University Hospitals Birmingham National Health Service Trust, and colleagues investigated whether assessing...
In a study reported in Journal of Clinical Oncology, Monique Terwijn, PhD, of the VU University Medical Centre in Amsterdam, and colleagues assessed the prognostic performance of flow cytometric minimal residual disease detection in acute myeloid leukemia (AML) patients aged < 60 years. They...
Although imatinib (Gleevec) is the initial therapy for chronic myeloid leukemia (CML), several second-generation tyrosine kinase inhibitors are now approved for the treatment of this disease. Michael Millenson, MD, of Fox Chase Cancer Center in Philadelphia, reviewed practical considerations in...
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ofatumumab (Arzerra) in combination with chlorambucil (Leukeran) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for...
For the first time, a genetic link specific to risk of childhood leukemia has been identified, according to a team of researchers from Memorial Sloan-Kettering Cancer Center, St. Jude Children’s Research Hospital, University of Washington, and other institutions. The discovery was reported...
Internal tandem duplications (ITDs) in the FMS-like tyrosine kinase 3 (FLT3) juxtamembrane region are observed in 20% to 30% of patients with acute myeloid leukemia (AML), and point mutations in the FLT3 activation loop are observed in 5% to 10%. FLT3-ITD mutations are associated with early relapse ...
St. Jude Children’s Research Hospital investigators have identified a protein that certain high-risk acute lymphoblastic leukemia (ALL) cells need to survive and have used that knowledge to fashion a more effective method of killing tumor cells. The findings appear in the August 29 edition of ...
A retrospective analysis of 110 patients with juvenile myelomonocytic leukemia found that single-unit, unrelated donor umbilical cord blood transplantation resulted in a 5-year disease-free survival rate of 44%. “Our data document that a significant proportion of children with this disease,...
A study published this week in the Journal of Clinical Investigation suggests that blocking the RUNX1 protein normally credited with suppressing leukemia may be a promising therapeutic strategy for acute myeloid leukemia. Transcription Factor RUNX1 Researchers from Cincinnati Children's Hospital...
In a study (Medical Research Council AML 15 Trial) reported in Journal of Clinical Oncology, Alan K. Burnett, MD, of Cardiff University School of Medicine and colleagues compared induction with daunorubicin/cytarabine, daunorubicin/cytarabine plus etoposide, and fludarabine/cytarabine/granulocyte...
In a study reported in Journal of Clinical Oncology, Anthony V. Moorman, PhD, of Newcastle University, and colleagues compared outcomes in children and adolescents with B-cell precursor acute lymphoblastic leukemia (ALL) and intrachromosomal amplification of chromosome 21 (iAMP21) in a trial in...
Intrachromosomal amplification of a region of chromosome 21 (iAMP21; three or more extra copies of RUNX1 on an abnormal chromosome 21) is a recently identified recurrent genomic abnormality associated with poorer outcome in acute lymphoblastic leukemia (ALL). In a study reported in Journal of...
Although small clinical studies of adoptive T-cell therapy in the treatment of advanced forms of leukemia have shown positive results, including putting some patients into complete remissions, progress in the development of this type of immunotherapy is limited by the lack of readily available,...
Minimal data are available on outcomes of second allogeneic hematopoietic stem cell transplantation from unrelated donors after first hematopoietic stem cell transplantation in patients with hematologic relapse of acute leukemia. In a study reported in Journal of Clinical Oncology, Maximilian...
Patients with advanced chronic lymphocytic leukemia (CLL) often receive allogeneic transplants that effectively “reboot” their own immune defenses, which then attack and potentially cure the hard-to-treat disease. However, there is a high rate of relapse in these patients, and the...
Scientists studying acute myeloid leukemia (AML) have discovered that rather than displacing hematopoietic stem cells in the bone marrow as previously believed, the cancer is in fact inhibiting production of downstream hematopoietic cells, effectively putting them to sleep. The findings were...
Pharmacyclics, Inc, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and...
New evidence suggests that using advanced genetics technologies to monitor for remaining cancer cells after treatment may soon become an effective tool to inform treatment decisions and ultimately predict patient outcomes for patients with a particularly aggressive form of acute lymphocytic...
A new analysis has found that among patients with chronic lymphocytic leukemia (CLL), African Americans more commonly present with advanced disease and tend to have shorter survival times than Caucasians despite receiving the same care. The results, published early online in Cancer, suggest that...
Two drugs were given Priority Review designation by FDA earlier this week. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia (CLL), based on final stage 1 data from the pivotal CLL11 trial. FDA also granted Priority Review to a pertuzumab (Perjeta)...
The 17p deletion in chronic lymphocytic leukemia (CLL) is associated with worse outcome in patients receiving standard chemotherapy. The Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib has shown durable antitumor activity in high-risk CLL. Adrian Wiestner, MD, PhD, of the National...
Durable remissions are uncommon with current treatments for relapsed chronic lymphocytic leukemia (CLL). Bruton’s tyrosine kinase (BTK) is an essential component of B-cell receptor signaling that mediates interactions with the tumor microenvironment and promotes survival and proliferation of...
In a phase III study, patients with previously untreated chronic lymphocytic leukemia (CLL) achieved an improvement in progression-free survival when treated with ofatumumab (Arzerra) in combination with chlorambucil vs chlorambucil alone. The study evaluated safety and efficacy of ofatumumab plus ...
Treating pediatric leukemia patients with a liposomal formulation of anthracycline-based chemotherapy at an intensified dose during initial treatment may result in high survival rates without causing any added heart toxicity, according to the results of a study published online in Blood, the...
Results from a phase I study of a new oral targeted drug, idelalisib (GS-1101), show the agent has potential as a therapy for relapsed or treatment-resistant chronic lymphocytic leukemia (CLL). The drug produced rapid and long-lasting tumor shrinkage in half of the patients treated with...
A study has identified microRNA-155 as a new independent prognostic marker and treatment target in patients with cytogenetically normal acute myeloid leukemia (AML). The study was led by researchers at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital...
Pharmacyclics, Inc, announced today that the enrollment target of 350 patients for RESONATE, its phase III study using ibrutinib monotherapy vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, was achieved on April 3, 2013. As...
A new study on how the progression of acute lymphocytic leukemia (ALL) is influenced by the bone marrow environment has demonstrated for the first time that targeting a specialized protein known as osteopontin may be an effective strategy to increase the efficacy of chemotherapy in patients with...
Researchers using patients’ own immune cells in an immunotherapy approach called anti-CD19 chimeric antigen receptor (CAR) T-cell therapy achieved responses in children whose acute lymphocytic leukemia (ALL) had returned after a bone marrow transplant, according to preliminary results...
Pharmacyclics, Inc, announced today that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm...