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At the 54th Annual Meeting of the American Society of Hematology (ASH), held in Atlanta, nearly 5,000 abstracts were presented in oral sessions and posters. As part of our ongoing comprehensive coverage from the meeting, here are several more studies of note. New Targets in Acute Myeloid Leukemia...
Waiting a short period of time for laboratory results to better characterize acute myeloid leukemia (AML) and design therapeutic approaches is a reasonable strategy, researchers in Toulouse, France, found after a retrospective review of 599 newly diagnosed AML patients treated by induction...
Patients ≥ 50 years old with leukemia/lymphoma are increasingly undergoing allogeneic hematopoietic cell transplants, raising questions about whether they might have better outcomes with transplants from younger allele-level 8/8 human leukocyte antigen (HLA)-matched unrelated donors than from...
The investigational oral FLT3 inhibitor quizartinib appears to be a safe and effective treatment for patients with relapsed or refractory acute myeloid leukemia (AML), according to results of a phase II trial presented at the 54th Annual Meeting of the American Society of Hematology (ASH) in...
Apogenix GmbH, a biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, announced that its lead compound, APG101 (Apocept), has been granted orphan drug designation from the FDA for the treatment of myelodysplastic syndromes (MDS)....
The authors are to be congratulated for successfully conducting a randomized study of FLAG (fludarabine, cytarabine, and granulocyte colony-stimulating factor [Neupogen]) vs FLAG plus liposomal daunorubicin (DaunoXome) in relapsed pediatric acute myeloid leukemia (AML). The difficulty in conducting ...
Optimal reinduction therapy for patients with relapsed pediatric acute myeloid leukemia (AML) remains undefined. Liposomal daunorubicin (DaunoXome), which offers the potential for reduced cardiotoxicity compared with traditional daunorubicin, is effective in this setting. Gertjan J.L. Kaspers, MD,...
In August 2011, researchers from the University of Pennsylvania published their breakthrough findings of a pilot study showing sustained remissions of up to 1 year in a small number of patients with advanced chronic lymphocytic leukemia (CLL) who had been treated with genetically engineered...
First, a clarification: Homoharringtonine is a natural plant alkaloid derived from Cephalotaxus fortunei; from the 1970s until the present, it was the subject of intensive research efforts by Chinese investigators to clarify its role as an antileukemic agent.1-3 Omacetaxine mepesuccinate (Synribo)...
Among 3,919 patients with acute myeloid leukemia (AML) who did not undergo transplantation in first complete remission, 1,271 relapsed and 19% were successfully treated with salvage therapy, according to an analysis of three AML trials in the United Kingdom. This percentage can be improved with a...
Adding bortezomib (Velcade) to standard daunorubicin and cytarabine induction chemotherapy for acute myeloid leukemia (AML) “resulted in an encouraging remission rate” in previously untreated older adults, according to results of Cancer and Leukemia Group B (CALGB/Alliance) study 10502. The...
Early trial results in single-agent therapy with the oral Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib have produced excellent responses in patients with chronic lymphocytic leukemia (CLL). Moreover, ibrutinib is extremely well tolerated, allowing patients to remain on trial and receive the...
The RESONATE trial is randomly assigning patients with refractory or relapsed CLL to either ofatumumab (Arzerra) or the investigational oral agent ibrutinib. Ofatumumab is an anti-CD20 monoclonal antibody like rituximab (Rituxan), but is more potent as a single agent. It was approved for refractory ...
High-dose monotherapy with vincristine sulfate liposome injection (Marqibo) resulted in meaningful clinical outcomes, including durable responses and bridging to hematopoietic cell transplantation, in adult patients with advanced, relapsed, and refractory Philadelphia chromosome (Ph)-negative acute ...
Forty years ago, President Richard Nixon announced a “war on cancer.” Some of that war’s first battles were won in the field of acute myeloid leukemia (AML) with two agents, cytarabine and daunorubicin, receiving U.S. Food and Drug Administration (FDA) approval based on their ability to produce...
Two small phase I studies at separate centers demonstrated encouraging results in the treatment of children with acute lymphoblastic leukemia (ALL) using reinfused autologous genetically engineered T cells. Results of both studies were presented at the Annual Meeting of the American Association for ...
Results from an ongoing phase II study reported at the recent Annual Meeting of the American Association for Cancer Research (AACR) demonstrate impressive activity with the use of ibrutinib in patients with chronic lymphocytic leukemia (CLL) and 17p deletions, which are associated with a poor...
Pharmacyclics, Inc, announced 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 of...
As was recently reported in Science Translational Medicine, Renier J. Brentjens, MD, and colleagues at Memorial Sloan-Kettering Cancer Center, New York, found that profound molecular remission was rapidly induced in patients with relapsed B-cell acute lymphoblastic leukemia (ALL) using autologous T ...
Quality nursing and ongoing education are critical for success in using gene-modified T-cell therapy for patients with chronic lymphocytic leukemia (CLL), said Cheryl Caravano, RN, at the recent Annual Congress of the Oncology Nursing Society. Ms. Caravano is a clinical nurse IV at Memorial...
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.1 Acute...
Findings from the Dana-Farber Cancer Institute ALL Consortium Protocol 00-01, recently reported by Lynda M. Vrooman, MD, Dana-Farber Cancer Institute, and colleagues in Journal of Clinical Oncology, indicate that postinduction dexamethasone and individualized dosing of Escherichia coli–derived...
Heavily pretreated patients with chronic lymphocytic leukemia (CLL) responded robustly to the first-in-class small-molecule inhibitor idelalisib (formerly GS1101), in a phase I dose-finding study reported in a press briefing prior to the 2013 ASCO Annual Meeting.1 Idelalisib, a specific inhibitor...
Even as a child, Janet D. Rowley, MD, found the intellectual order and logic of science appealing. Born on April 5, 1925, in New York, Dr. Rowley’s parents, Hurford and Ethel Ballantyne Davison, moved the family to Chicago 2 years later. Both educators, the Davisons encouraged their only child in...
Acute lymphoblastic leukemia (ALL) is the most common cancer in children, and the incidence of the disease varies by ethnicity. Available evidence indicates an inherited predisposition to ALL, but the genetic basis of ALL susceptibility in diverse ancestry has not been examined in detail. Xu and...
The Leukemia & Lymphoma Society (LLS) recently joined the Dana-Farber Cancer Institute in Boston to establish a network of sites for clinical trial testing of innovative blood cancer therapies in community oncology settings across the country. This Blood Cancer Research Partnership (BCRP) will...
Among the hematologic cancers for which molecular causes remain unclear are chronic neutrophilic leukemia and atypical (BCR-ABL1–negative) chronic myeloid leukemia. Both disorders currently are diagnosed on the basis of neoplastic expansion of granulocytic cells and exclusion of genetic factors...
Acute myeloid leukemia (AML) is a clinically and molecularly heterogeneous disease.1 This concept has been supported by more than 4 decades of studies showing distinct outcomes of subsets of patients that differ in age, disease type (primary vs secondary vs therapy-related), and cytogenetic and...
In a study by the Cancer Genome Atlas Research Network reported in The New England Journal of Medicine, genomes of 200 adult cases of de novo acute myeloid leukemia (AML) were analyzed by whole-genome sequencing (n = 50) or whole-exome sequencing (n = 150) to identify mutations and relationships...
A trio of presentations at the ASCO Annual Meeting focused on two promising investigational drugs for the treatment of chronic lymphocytic leukemia (CLL). These two drugs—idelalisib and obinutuzumab—join a list of new approaches showing potential. Idelalisib Alone A phase I dose-ranging study of...
Treatment with lenalidomide (Revlimid) as initial therapy induced long-lasting responses in a phase II study of 60 patients with chronic lymphocytic leukemia (CLL). “Overall, 35 patients (58%) patients had responses lasting more than 36 months and were considered long-term responders,” the...
Among the more than 200 types of cancer are those called “forgotten” or “orphan” cancers, with fewer than 40,000 new cases each year. They present treatment challenges in community cancer centers. Because of the low incidence of these diseases, such as chronic myeloid leukemia, acute promyelocytic...
Two drugs were recently given Priority Review designation by FDA. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. FDA also granted...
The 12th International Conference on Malignant Lymphoma was held June 19-22, 2013, in Lugano, Switzerland. Over 3,000 hematologists, clinical oncologists, pathologists, and leading researchers attended the meeting, which featured new research on B-cell malignancies, follicular lymphoma, as well as...
Pharmacyclics, Inc, recently 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)...
All-trans retinoic acid (ATRA) plus arsenic trioxide bested the already high remission rates achieved by ATRA with chemotherapy, the standard of care for acute promyelocytic leukemia, in a phase III multicenter trial among patients with low-to-intermediate risk acute promyelocytic leukemia....
Durable remissions are uncommon with current treatments for relapsed chronic lymphocytic leukemia (CLL). Bruton’s tyrosine kinase is an essential component of B cell–receptor signaling that mediates interactions with the tumor microenvironment and promotes survival and proliferation of CLL cells....
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,...
The ASCO Post article, “Ibrutinib CLL Trial: Where is the Equipoise?” published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the...
We acknowledge the letters submitted to The ASCO Post from a patient advocate and a chronic lymphocytic leukemia (CLL) patient enrolled on the RESONATE study (PCYC-1112-CA). At Pharmacyclics, we are committed to adhering to high scientific and ethical standards as we strive to develop novel...
In a previous issue of The ASCO Post, Dr. Susan O’Brien wrote, “It is my understanding that the FDA strongly opposed allowing crossover [in the RESONATE trial]. I presume that is because the FDA also wants to see if there is a survival advantage.”1 The lack of crossover seems a valid concern to me...
I am writing with regard to two articles on the ethical imperative of clinical equipoise written by Susan O’Brien, MD, and Stephen J. Schuster, MD, and published recently in The ASCO Post.1,2 I was a victim of Pharmacyclics’ policies during one of their randomized ibrutinib trials (PCI-32765)...
Disease recurrence is a devastating event after allogeneic hematopoietic stem cell transplantation as treatment for acute myeloid leukemia (AML). Median time to relapse is approximately 4 months and the majority of relapses occur within 2 years after transplant. The prognosis is usually poor....
Minimal data are available on outcomes of second allogeneic hematopoietic stem cell transplantation from unrelated donors after a first transplant in patients with hematologic relapse of acute leukemia. In a study reported in Journal of Clinical Oncology, Maximilian Christopeit, MD, of University...
“The management of chronic lymphocytic leukemia (CLL) is undergoing profound changes. Several new drugs have been approved for CLL treatment (fludarabine, bendamustine [Treanda], and the monoclonal antibodies alemtuzumab [Campath], rituximab [Rituxan], and ofatumumab [Arzerra]), and many more drugs ...
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 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 the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On November 1, 2013, obinutuzumab (Gazyva) was approved...
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...