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The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for ...
Cytogenetically normal acute myeloid leukemia (AML) is the largest and most heterogeneous cytogenetic AML subgroup. As reported in the Journal of Clinical Oncology, Pastore et al have developed a widely applicable prognostic model for cytogenetically normal AML that combines established patient and ...
In a study reported in the Journal of Clinical Oncology, Russell et al found that immunoglobulin heavy chain (IGH@) translocations were present in a substantial proportion of younger patients with acute lymphoblastic leukemia (ALL), including those with B-cell precursor ALL. However, IGH@...
Research in mice and human cell lines has identified an experimental compound dubbed TTT-3002 as potentially one of the most potent drugs available to block genetic mutations in cancer cells blamed for some forms of treatment-resistant leukemia. The study by Ma et al, published in Blood, found that ...
The results from a phase I study of a new investigational epigenetic therapy called OTX015, a small-molecule inhibitor that blocks the activity of bromodomain and extraterminal (BET)-bromodomain proteins, is showing clinical activity in some blood cancers, including leukemia and lymphoma. The study ...
Patients with chronic myeloid leukemia (CML) in the chronic phase who are resistant or intolerant to imatinib (Gleevec) can experience long-term benefit with dasatinib (Sprycel), according to results of a randomized phase III study. The CA180-034 study also found that early molecular and...
In the phase II US Leukemia Intergroup Trial E1905 reported in the Journal of Clinical Oncology, Prebet et al found that prolonged administration of lower-dose azacitidine produced a high response rate in patients with myelodysplastic syndrome or acute myeloid leukemia (AML) with myelodysplastic...
In a UK phase II study reported in the Journal of Clinical Oncology, Hillmen et al assessed the safety and activity of adding rituximab (Rituxan) to chlorambucil (Leukeran) in first-line treatment of chronic lymphocytic leukemia (CLL). Such a regimen may be an alternative to fludarabine-based...
In a recent study published in Science Translational Medicine, Davila et al found that 88% of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) who were treated with genetically modified versions of their own immune cells achieved overall complete response. Most...
In a study reported in the Journal of Clinical Oncology, Bhojwani et al from St. Jude Children’s Research Hospital assessed clinical, pharmacokinetic, and genetic risk factors for methotrexate-related clinical neurotoxicity and asymptomatic leukoencephalopathy in children with acute...
Asparaginase treatment, standard in pediatric acute lymphoblastic leukemia (ALL) regimens, is excluded or used for shorter durations in treatment of adults with ALL due to risk of toxicity. In a study reported in Journal of Clinical Oncology, Douer et al evaluated a pegaspargase (Oncaspar) dosing...
In a study reported in the Journal of Clinical Oncology, Bulian et al found that CD49d-positive chronic lymphocytic leukemia (CLL) patients have significantly poorer overall survival and treatment-free survival and that CD49d status is the strongest flow cytometry–based predictor of overall...
In response to FDA's approval earlier this week of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who had received at least one prior therapy, The Leukemia & Lymphoma Society (LLS) issued the following statement: "After the FDA designated ibrutinib as a...
Researchers have discovered a preleukemic stem cell that may be the first step in initiating disease and also the culprit that evades therapy and triggers relapse in patients with acute myeloid leukemia (AML). The research, published online in Nature, is a significant step forward in...
The U.S. Food and Drug Administration (FDA) has granted full approval to omacetaxine mepesuccinate (Synribo) for injection. The full approval was based on the final analysis of two phase II trials that evaluated the efficacy and tolerability data of omacetaxine. The agent received an accelerated...
Findings from a study by Puissant et al suggest that the wild-type form of enzyme SYK pairs with FLT3, the most commonly mutated enzyme found in acute myeloid leukemia (AML), to promote progression of the cancer. The molecular partnership also promotes AML cells’ resistance to treatment with...
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, was previously...
Using data from the whole-genome sequencing of a pair of 3-year-old female monozygotic twins, one healthy and one with the multilineage form of acute myeloid leukemia (AML), a team of scientists from China and the United States have identified a novel molecular target that could offer a new...
The finding that the BRAF V600E mutation is present in nearly all cases of hairy cell leukemia has resulted in the use of BRAF inhibitors to treat chemotherapy-resistant disease, with good responses to vemurafenib (Zelboraf) being observed. BRAF inhibition has been thought to result in...
Use of standard chemotherapy is difficult in patients with relapsed chronic lymphocytic leukemia (CLL) who have significant coexisting medical conditions. In a phase III trial reported in The New England Journal of Medicine, Furman et al found that the combination of idelalisib, an oral inhibitor...
Chronic lymphocytic leukemia (CLL) is associated with increased risk of skin cancer. In a study reported in JAMA Dermatology, Velez et al attempted to determine whether progression of CLL indicated by advanced Rai stage is associated with worse skin cancer outcomes. They found that risk of death...
In a study reported in the Journal of Clinical Oncology, Marcucci et al assessed whether including epigenetic changes—ie, DNA methylation—as molecular risk factors could improve risk stratification in acute myeloid leukemia (AML). They found that a seven-gene score integrating DNA...
Obinutuzumab (Gazyva) is a glycoengineered type 2 anti-CD20 antibody that appears to exhibit increased activity against chronic lymphocytic leukemia cells (CLL), with increased antibody-dependent cellular cytotoxicity and reduced complement-dependent cytotoxicity, compared with rituximab (Rituxan). ...
Chemoimmunotherapy has produced improved response and survival in young patients with chronic lymphocytic leukemia (CLL), but its use in elderly patients has been limited by myelosuppression and infection. In a phase IB/II study reported in The Lancet Oncology, O’Brien et al assessed the use...
Many patients with chronic-phase chronic myelogenous leukemia (CML) in complete molecular response have molecular relapse after discontinuation of imatinib (Gleevec) treatment. In a French multicenter observational study reported in the Journal of Clinical Oncology, Rousselot et al assessed the...
The availability of the tyrosine kinase inhibitor imatinib (Gleevec) has dramatically increased survival in chronic myeloid leukemia (CML). Nonadherence to therapy with imatinib and other tyrosine kinase inhibitors is associated with disease progression and treatment resistance. In a study reported ...
In a prospective matched-pairs analysis reported in the Journal of Clinical Oncology, Stelljes et al in the German AML Cooperative Group compared outcomes with allogeneic stem cell transplantation vs conventional postremission chemotherapy in patients aged < 60 years with acute myeloid leukemia...
Dasatinib (Sprycel) resulted in “faster and deeper responses” compared to imatinib (Gleevec) among patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML), according to a 3-year follow-up of the randomized phase III DASISION (Dasatinib vs Imatinib Safety In...
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...