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Showing 51 - 100ASH 2018: MEDALIST: Luspatercept in Patients With Myelodysplastic Syndrome Requiring Red Blood Cell Transfusion
In the phase III MEDALIST clinical trial, luspatercept significantly reduced the need for frequent blood transfusions in just over half (53%) of patients with myelodysplastic syndromes (MDS) who were anemic, required regular red blood cell transfusions, and showed abnormal iron overload in red...
ASH 2018: Large Single-Arm Trial of Hydroxyurea for Sickle Cell Anemia in Sub-Saharan Africa
The largest prospective trial of hydroxyurea for sickle cell anemia (SCA) has shown that this treatment—long the standard of care for treating SCA in developed countries—is feasible, accepted, well tolerated, and safe for children living in sub-Saharan Africa. Tshilolo et al reported...
MRD-Guided Azacitidine Treatment in Myelodysplastic Syndrome and Acute Myeloid Leukemia
In a German phase II trial (RELAZA2) reported in The Lancet Oncology, Platzbecker et al found that minimal residual disease (MRD)–guided treatment with azacitidine was successful in preventing hematologic relapse in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia...
Effect of Donor Clonal Hematopoiesis of Indeterminate Potential in Allogeneic Hematopoietic Stem Cell Transplantation
In a study reported in the Journal of Clinical Oncology, Frick et al found that allogeneic hematopoietic stem cell transplantation (HSCT) from donors with clonal hematopoiesis of indeterminate potential (CHIP) appears safe and not associated with poorer survival when donors are older, related...
New Report Demonstrates Cost of Blood Cancer Care
The costs to treat blood cancer are higher than costs for other cancers, and the costs incurred by a patient diagnosed with a blood cancer do not return to precancer levels, according to a Milliman study commissioned by The Leukemia & Lymphoma Society (LLS). The study—The...
Adoptive T-Cell Therapy for Progressive Multifocal Leukoencephalopathy
An emerging treatment known as adoptive T-cell therapy has proven effective in a phase II clinical trial for treating progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain infection sometimes observed in patients with cancer and other diseases in which the immune...
Genomic Classification of Myeloproliferative Neoplasms and Integration in Predictive Models
In a study reported in The New England Journal of Medicine, Grinfeld et al identified distinct genomic subgroups among patients with myeloproliferative neoplasms that, when combined with clinical variables, offered the potential for individualized predictions of clinical outcomes. Study Details...
Frederick L. Locke, MD, on CAR T-Cell Therapy: Major Milestones
Frederick L. Locke, MD, of Moffitt Cancer Center, discusses the key studies behind the development of CAR T cells, major adverse events and management strategies, and the potential of this revolutionary treatment.
Outcomes Associated With Mutation Persistence After HSCT for Myelodysplastic Syndrome
In a single-institution study reported in The New England Journal of Medicine, Duncavage et al found that mutation clearance after allogeneic hematopoietic stem cell transplantation (HSCT) was associated with better outcomes in patients with myelodysplastic syndrome. Study Details The study...
FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy
The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...
FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant
The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...
Response to Ibrutinib in Symptomatic Untreated Waldenström’s Macroglobulinemia
In a study reported in the Journal of Clinical Oncology, Treon et al found that ibrutinib monotherapy was highly active in patients with previously untreated Waldenström’s macroglobulinemia, with better response in patients without CXCR4 mutation. Ibrutinib has been shown to be active in ...
Monthly High-Dose Vitamin D and Cancer Risk
In a study reported in JAMA Oncology, Scragg et al found that monthly high-dose vitamin D supplementation, without calcium, was not associated with a reduced risk of developing cancer. Study Details The current analysis is a post hoc analysis of the Vitamin D Assessment (ViDA) study, which...
FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...
EHA 2018: Ruxolitinib Reduces Risk of Thrombosis, Death in Patients With Polycythemia Vera
A new comparison study showed that among polycythemia vera patients who were resistant or intolerant to hydroxyurea, those treated with ruxolitinib (Jakavi) had a significantly reduced risk of thrombosis and death compared to those who received best available therapy. The study findings are based...
2018 ASCO: iNNOVATE Trial Evaluates Ibrutinib in Combination With Rituximab in Patients With Waldenström's Macroglobulinemia
Results from a preplanned interim analysis of the phase III iNNOVATE (PCYC-1127) study evaluating the investigational use of ibrutinib (Imbruvica) in combination with rituximab (Rituxan) in relapsed/refractory and treatment-naive patients with Waldenström’s macroglobulinemia were...
Meletios A. Dimopoulos, MD, on Waldenström’s Macroglobulinemia
Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, discusses phase III findings on ibrutinib/rituximab vs placebo/rituximab in Waldenström’s macroglobulinemia (Abstract 8003).
Update Regarding Tazemetostat Clinical Program
On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...
FDA Approves Fostamatinib Disodium Hexahydrate for Chronic Immune Thrombocytopenia in Adult Patients
On April 17, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Fostamatinib is an oral spleen ...
Clinical Hold Lifted on U.S. Studies of BPX-501
On April 11, Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring...
AACR 2018: Prior Chemotherapies May Impair Pediatric Patients’ Ability to Develop Effective CAR T Cells
Pediatric patients with solid tumors may have poor quality T cells compared to patients with leukemia, and certain chemotherapies were detrimental to the T cells and their potential to become chimeric antigen receptor (CAR) T cells, according to data presented during a media preview for the...
Novel PI3Kδ Inhibitor in Relapsed or Refractory Hematologic Malignancies
In a phase I trial reported in The Lancet Oncology, Burris et al determined the phase II dose of the next-generation PI3Kδ inhibitor umbralisib and found evidence of the agent’s activity in relapsed or refractory hematologic malignancies. Umbralisib exhibits improved PI3K isoform...
Cognitive Decline Prevalent Among Elderly Patients With Hematologic Cancers
A sizable percentage of elderly patients with blood-related cancers such as leukemia and multiple myeloma are apt to show signs of diminished cognitive functioning—a decline that may impact their survival—a new study by investigators at Dana-Farber Cancer Institute and Brigham and...
Clinical Hold on BPX-501 Trials in the United States Announced
On January 30, Bellicum Pharmaceuticals announced it has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501—an agent being studied to improve outcomes for patients undergoing stem cell transplant who lack a matched donor—have been placed...
Stephen M. Ansell, MD, PhD, on Hematologic Malignancies: Immunotherapy Update
Stephen M. Ansell, MD, PhD, of the Mayo Clinic, discusses integrating immune checkpoint inhibitors, improving efficacy, and reducing toxicity when treating blood cancers.
Cognitive Function After Hematopoietic Cell Transplantation for Hematologic Malignancy
In a prospective longitudinal study reported in the Journal of Clinical Oncology, Sharafeldin et al found that cognitive function after hematopoietic cell transplantation (HCT) for hematologic malignancy was impaired among those receiving myeloablative allogeneic HCT, with a delayed effect being...
ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer
People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...
ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura
In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...
ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant
Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...
ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
Alok A. Khorana, MD, on The Costs of VTE in Cancer Patients: Expert Perspective
Alok A. Khorana, MD, of the Cleveland Clinic, discusses the prevalence of venous thromboembolism in cancer patients treated at U. S. emergency departments and associated costs, mortality, and hospital admissions in the United States (Abstract 219).
ASH 2017: Rapid Responses, Few Adverse Effects Seen With Targeted Agent in Phase I Trial in Systemic Mastocytosis
In a phase I trial, patients with an advanced or aggressive form of systemic mastocytosis, a rare blood disorder, had rapid and durable responses with few adverse effects following treatment with an investigational drug that targets the genetic mutation found in more than 90% of cases. Results were ...
Watch for More From ASH 2017
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
ASH 2017: Direct Oral Anticoagulant May Reduce Recurrence of VTE in Patients With Cancer
People with cancer have an increased risk of developing blood clots, with roughly one in five experiencing venous thromboembolism (VTE). International guidelines recommend treatment using low–molecular-weight heparin, an anticoagulant that is injected subcutaneously; however, new results from ...
ASCO Clinical Practice Guideline Update: Platelet Transfusion for Patients With Cancer
As reported in the Journal of Clinical Oncology by Charles A. Schiffer, MD, of Karmanos Cancer Institute, Wayne State University School of Medicine, and colleagues, ASCO has issued a clinical practice guideline update on platelet transfusions in patients with cancer. The updated guideline replaces ...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
FDA Approves Vemurafenib for Certain Patients With Erdheim-Chester Disease
On November 6, the U.S. Food and Drug Administration (FDA) expanded the approval of vemurafenib (Zelboraf) to include the treatment of certain adult patients with Erdheim-Chester disease (ECD), a rare cancer of the blood. Vemurafenib is indicated to treat patients whose cancer cells have a specific ...
Anti–T-Lymphocyte Globulin and Chronic GVHD-Free Survival in Unrelated Myeloablative HCT
A double-blind phase III trial has shown no benefit of anti–T-lymphocyte globulin (ATLG) vs placebo on chronic graft-vs-host disease (GVHD)-free survival in patients undergoing human leukocyte antigen (HLA)-matched unrelated myeloablative hematopoietic cell transplantation (HCT). The study...
Ruben A. Mesa, MD, on Myeloproliferative Neoplasms: Managing PV and ET
Ruben A. Mesa, MD, of The University of Texas Health San Antonio Cancer Center, discusses the role of JAK2 inhibitors in treating polycythemia vera and essential thrombocythemia and how to develop individualized therapy based on risk stratification.
Potential Biomarkers to Identify Patients at Risk for Neurotoxicity From CAR T-Cell Therapy
Although lymphodepletion chemotherapy followed by an infusion of CD19-targeted chimeric antigen receptor (CAR)-modified T cells has produced high response rates in phase I studies of patients with refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia...
Momelotinib vs Ruxolitinib in Janus Kinase Inhibitor–Naive Myelofibrosis
In the phase III SIMPLIFY-1 noninferiority trial reported in the Journal of Clinical Oncology, Mesa et al found that the selective Janus kinase (JAK) 1 and 2 inhibitor momelotinib was noninferior to ruxolitinib (Jakafi) in spleen response, but not symptom response, in JAK inhibitor–naive...
Survey on Training in Geriatrics/Geriatric Oncology for Hematology-Oncology Fellows
Results from an ASCO-sponsored survey study indicate that despite professed interest in the area, most hematology-oncology fellows have inadequate training in geriatrics/geriatric oncology. These findings were reported in the Journal of Oncology Practice by Maggiore et al. Study Details The...
Immunologic Biomarkers and Survival in Third-Generation CAR T-Cell Therapy
A phase I/IIa study investigating the safety and effectiveness of a third-generation CD19-specific chimeric antigen receptor (CAR) T-cell therapy in patients with lymphoma or leukemia has found that the treatment led to a complete response in 6 of the 15 patients in the study and that overall...
Early-Phase Study Finds Vitamin C May Activate TET2 Function
Vitamin C may “tell” faulty stem cells in the bone marrow to mature and die normally, instead of multiplying to cause blood cancers. This is the finding of a study led by researchers from Perlmutter Cancer Center at NYU Langone Health, and published by Cimmino et al in Cell....
Off-the-Shelf, Virus-Specific T Cells for Treating Viral Infections After Transplantation
In a phase II study reported in the Journal of Clinical Oncology, Tzannou et al found that use of off-the-shelf, broad-coverage, adoptively transferred, virus-specific T cells was feasible and effective in treating viral infections in patients who had undergone allogeneic hematopoietic stem cell...
Association of Pretransplant Vitamin D Deficiency and Relapse in Myeloid Malignancies
A German retrospective study has found that pretransplantation vitamin D deficiency is associated with an increased risk of relapse in patients undergoing allogeneic stem cell transplantation (SCT) for myeloid malignancies. These findings were reported by Radujkovic et al in the Journal of Clinical ...
Effect of Azithromycin on Airflow Decline–Free Survival After Allogeneic HSCT for Hematologic Malignancy
The French phase III ALLOZITHRO trial, stopped early due to excessive hematologic relapse in the azithromycin group, showed worse airflow decline–free survival with azithromycin vs placebo after hematopoietic stem cell transplantation (HSCT) for hematologic malignancy. The study findings were ...
Clonal Hematopoiesis in Patients With Nonhematologic Cancers
In a study of nearly 9,000 people treated for solid tumors, researchers found that radiation treatment and tobacco use were linked to higher rates of blood-based DNA mutations that could lead to a higher risk for blood cancers such as leukemia. The study, published by Coombs et al in...
Italian Study of Serotherapy to Prevent GVHD in Pediatric Hematologic Malignancy
In an Italian phase III trial reported by Locatelli et al in The Lancet Oncology, a lower vs higher dose of rabbit anti–T-lymphocyte globulin (ATLG) was associated with a nonsignificantly greater incidence of acute graft-vs-host disease but better event-free and overall survival in children...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
