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Showing 301 - 350FDA Grants Venetoclax Breakthrough Therapy Designation for Geriatric Patients With Acute Myeloid Leukemia
On July 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for venetoclax (Venclexta) in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. FDA...
Response to CAR T-Cell Therapy After Ibrutinib in Chronic Lymphocytic Leukemia
As reported by Turtle et al in the Journal of Clinical Oncology, anti-CD19 chimeric antigen receptor–modified (CAR) T-cell therapy produced high response rates in patients with chronic lymphocytic leukemia previously treated with ibrutinib (Imbruvica). Study Details In the phase I/II study, ...
Effect of Methotrexate and Corticosteroid Strategies on Neurocognitive Function in Patients With B-Lineage ALL
In a Children’s Oncology Group (COG) study (AALL06N1) reported in the Journal of Clinical Oncology, Hardy et al found that age < 10 years at diagnosis was associated with poorer neurocognitive function in patients with high-risk B-lineage acute lymphoblastic leukemia regardless of...
CD33 Splicing Polymorphism and Response to Gemtuzumab Ozogamicin in AML
In an analysis of the phase III Children’s Oncology Group AAML0531 trial, published by Lambda et al in the Journal of Clinical Oncology, the CD33-targeted immunoconjugate gemtuzumab ozogamicin was shown to have benefit among patients with de novo acute myeloid leukemia (AML) who carry the CC...
FDA’s Advisory Committee Supports CTL019 in Pediatric, Young Adult Patients With B-Cell ALL
Today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the biologics license application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory pediatric and young adult...
Blinatumomab Granted Full Approval to Treat Relapsed or Refractory B-cell Precursor ALL in Adults and Children
On July 11, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include overall survival data from the phase III TOWER study. The approval converts blinatumomab's accelerated approval to a full approval. The sBLA...
FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML
On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...
Idarubicin vs High-Dose Daunorubicin Induction in Newly Diagnosed Acute Myeloid Leukemia
A Korean phase III trial has shown no difference in outcomes with high-dose daunorubicin vs idarubicin induction in newly diagnosed acute myeloid leukemia, although high-dose daunorubicin was associated with better outcomes in patients with FLT3–internal tandem duplication (ITD) mutation....
Adding Midostaurin to Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation
In a phase III trial (Cancer and Leukemia Group B 10603 [RATIFY]/Alliance) reported in The New England Journal of Medicine, Stone et al found that the addition of midostaurin (Rydapt) to standard chemotherapy improved overall survival in patients with newly diagnosed acute myeloid leukemia with...
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...
EHA 2017: Half of Chronic-Phase Philadelphia Chromosome–Positive CML Patients Stay in Treatment-Free Remission 2 Years After Stopping Nilotinib
New data from two clinical trials—ENESTfreedom and ENESTop—demonstrates that approximately half of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase, were able to maintain treatment-free remission after stopping treatment with ...
EHA 2017: Updated CTL019 ELIANA Data Show Durable Remission Rates in Children, Young Adults With Relapsed/Refractory B-Cell ALL
Updated results from the ELIANA clinical trial demonstrated CTL019 (tisagenlecleucel) remission rates are maintained at 6 months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). These data from this pivotal trial of CTL019 show that 83% (52...
FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of Certain Hematologic Malignancies
On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The approval provides a...
Phase III CASCADE Trial of Front-Line Vadastuximab Talirine in AML Discontinued
Seattle Genetics has discontinued its phase III CASCADE clinical trial of front-line vadastuximab talirine (SGN-CD33A) in older acute myeloid leukemia (AML) patients. The phase III CASCADE clinical trial is a randomized, double-blind, placebo-controlled study evaluating vadastuximab talirine...
ICML 2017: Phase III GENUINE Trial: Ublituximab Plus Ibrutinib in High-Risk CLL
Data was recently presented from the phase III GENUINE trial of ublituximab, a novel glycoengineered anti–CD20 monoclonal antibody, in combination with ibrutinib (Imbruvica), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of high-risk chronic lymphocytic leukemia (CLL), at the...
ICML 2017: Triplet Combination of Umbralisib, Ublituximab, and Ibrutinib in CLL/SLL/NHL
Data from the chemotherapy-free triple combination of umbralisib, an oral, next generation PI3K delta inhibitor; ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody; and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and...
First-In-Human Clinical Trial Aims to Extend Remission for Children and Young Adults With Leukemia Treated With T-Cell Immunotherapy
After phase I results of Seattle Children's Pediatric Leukemia Adoptive Therapy (PLAT-02) trial, published by Gardner et al in Blood, showed T-cell immunotherapy to be effective in sending 93% of patients with relapsed or refractory acute lymphoblastic leukemia (ALL) into complete initial...
FDA Approves Midostaurin in Combination With Chemotherapy for Newly Diagnosed FLT3-Positive Acute Myeloid Leukemia
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive, as detected by an FDA-approved test, in combination with standard cytarabine and...
Blinatumomab After Failure of TKI Treatment in B-Precursor Acute Lymphoblastic Leukemia
In a phase II trial reported in the Journal of Clinical Oncology, Martinelli et al found that blinatumomab (Blincyto) produced complete responses in patients with relapsed/refractory Philadelphia chromosome–positive (Ph+) B-precursor acute lymphoblastic leukemia (ALL) progressing after...
Mercaptopurine Ingestion Habits and Risk of Relapse in Children With Acute Lymphoblastic Leukemia
In a report from the Children’s Oncology Group Study AALL03N1 published in the Journal of Clinical Oncology, Landier et al found no association between oral mercaptopurine ingestion habits in children with acute lymphoblastic leukemia and risk of relapse after adjustment for medication...
Association of DNA Thioguanine Nucleotide Concentration and Outcome During Maintenance Therapy for Childhood ALL
In a substudy of a European phase III trial (Nordic Society of Pediatric Hematology and Oncology ALL2008) reported in The Lancet Oncology, Nygaard Nielsen et al found that higher leukocyte DNA-incorporated thioguanine nucleotide (DNA-TGN) levels were associated with an improved relapse-free...
Benefit of Imatinib in Chronic Myeloid Leukemia Persists Long Term in IRIS Trial
Long-term follow-up of patients with chronic myeloid leukemia (CML) randomized to imatinib in the IRIS trial was reported by Hochhaus et al in The New England Journal of Medicine. In the open-label crossover-design trial, 1,106 patients with CML were randomized to receive imatinib at 400 mg/d (n = ...
Blinatumomab vs Chemotherapy in Advanced Acute Lymphoblastic Leukemia
In the phase III TOWER trial reported in The New England Journal of Medicine, Kantarjian et al found that blinatumomab (Blincyto) treatment improved overall survival vs chemotherapy in heavily pretreated patients with B-cell precursor acute lymphoblastic leukemia (ALL). Blinatumomab received...
Clofarabine-Based Consolidation in Younger Patients With Acute Myeloid Leukemia in First Remission
In a French phase II trial reported in the Journal of Clinical Oncology, Thomas et al found that clofarabine-based consolidation may provide improved relapse-free survival vs conventional high-dose cytarabine in postremission treatment in younger patients with acute myeloid leukemia (AML) and no...
Children, Parents Overreport Leukemia Treatment Adherence
New research suggests that young patients with acute lymphocytic leukemia (ALL) and their parents are likely to report to their physician that they took more of their anticancer medication than they actually did. The study, published by Landier et al in Blood, found that 84% of patients with ALL...
Adding Idelalisib to Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
As reported by Zelenetz et al in The Lancet Oncology, an interim analysis of a phase III trial has shown the superiority of adding the phosphoinositide-3-kinase δ inhibitor idelalisib (Zydelig) to bendamustine/rituximab (Rituxan) in patients with relapsed or refractory chronic lymphocytic...
High Financial Burden for CML Patients Enrolled in Medicare Part D Receiving Targeted Oral Therapy
In a study reported in the Journal of Oncology Practice, Shen et al found that more than three-quarters of patients receiving targeted oral therapy for chronic myeloid leukemia (CML) reached the catastrophic phase of the Medicare Part D benefit within the calendar year of starting such treatment....
Diagnosis and Management of AML in Adults: 2017 European LeukemiaNet Recommendations From an International Expert Panel
An international panel of experts has released updated evidence-based and expert opinion–based recommendations for the diagnosis and treatment of acute myeloid leukemia (AML) in adults. The recommendations were issued by the European LeukemiaNet (ELN) and published by Döhner et al in...
Three Genetic Alterations Identified in Non–Down Syndrome Pediatric Acute Megakaryoblastic Leukemia
Research led by St. Jude Children’s Research Hospital has identified three genetic alterations to help identify high-risk pediatric patients with acute megakaryoblastic leukemia (AMKL) who may benefit from allogeneic stem cell transplants. The study, published by de Rooij et al in Nature...
Venetoclax Plus Rituximab Studied in Relapsed or Refractory Chronic Lymphocytic Leukemia
In a phase Ib study reported in The Lancet Oncology, Seymour et al found that the combination of the BCL2 inhibitor venetoclax (Venclexta) and the anti-CD20 monoclonal antibody rituximab (Rituxan) was highly active in patients with relapsed or refractory chronic lymphocytic leukemia...
ASH 2016: Children With Down Syndrome and ALL Fare as Well as Other Children Treated on ALL Consortium Protocols
Despite an elevated risk of toxicity from chemotherapy, children with Down syndrome and acute lymphoblastic leukemia (ALL) did not experience higher rates of relapse or treatment-related mortality compared with other children treated on Dana-Farber Cancer Institute ALL Consortium Protocols,...
ASH 2016: Ibrutinib and TGR-1202 Combination Yields Encouraging Results in Patients With Relapsed Forms of Leukemia or Lymphoma
A combination of two targeted agents has demonstrated safety as well as encouraging signs of effectiveness in a phase I clinical trial in patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Davids et al reported the findings at the 58th American ...
ASH 2016: IKZF1 Gene Mutations Found to Increase Hereditary Risk for Acute Lymphocytic Leukemia in Children
A late-breaking abstract being presented by Churchman et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-2) identifies inherited genetic mutations in the gene IKZF1 that confer a higher likelihood of developing pediatric...
Martin Schrappe, MD, on Childhood ALL: Study Results on Reducing Treatment Burden (German Language Version) 
Martin Schrappe, MD, of Christian-Albrechts University Kiel, discusses in German study findings on reduced intensity delayed intensification in standard-risk patients defined by minimal residual disease in childhood acute lymphoblastic leukemia (Abstract 4).
Julie Vose, MD, MBA, and Anjali Advani, MD, on AML: Results of Two Trials on Vadastuximab Talirine
Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and Anjali Advani, MD, of the Cleveland Clinic, discuss study findings on vadastuximab talirine as monotherapy and, in another trial, vadastuximab talirine plus hypomethylating agents in older patients with AML (Abstracts 590, 591).
Julie Vose, MD, MBA, and Mhairi Copland, MB, ChB, PhD, on CML: Data From the British DESTINY Study
Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and Mhairi Copland, MB, ChB, PhD, of the Paul O’Gorman Leukaemia Research Centre at the University of Glasgow, discuss decreasing the dose of tyrosine kinase inhibitors in CML patients with stable molecular responses (Abstract 938).
Harry P. Erba, MD, PhD, on AML: Early Study Results on Vadastuximab Talirine
Harry P. Erba, MD, PhD, of the University of Alabama at Birmingham, discusses phase Ib findings on vadastuximab talirine in combination with 7+3 induction therapy for patients with newly diagnosed AML (Abstract 211).
Jeffrey E. Lancet, MD, on AML: Subgroup Analysis of a Phase III Trial
Jeffrey E. Lancet, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses study findings on survival following allogeneic hematopoietic cell transplantation in older, high-risk acute myeloid leukemia patients initially treated with CPX-351 liposome injection vs standard...
Terry J. Fry, MD, on ALL: MRD and CAR Therapy
Terry J. Fry, MD, of the Pediatric Oncology Branch of the National Cancer Institute, discusses minimal residual disease–negative complete remissions following anti-CD22 chimeric antigen receptor in children and young adults with relapsed/refractory acute lymphoblastic leukemia (Abstract 650).
Martin Schrappe, MD, on Childhood ALL: Study Results on Reducing Treatment Burden
Martin Schrappe, MD, of Christian-Albrechts University Kiel, discusses study findings on reduced intensity delayed intensification in standard-risk patients defined by minimal residual disease in childhood acute lymphoblastic leukemia (Abstract 4).
ASH 2016: Interim Analysis Shows Adding Lenalidomide Maintenance Therapy to Chemoimmunotherapy Prolongs Progression-Free Survival in High-Risk CLL
The combined use of genetic markers and minimal residual disease assessment (MRD) has made it easier to identify chronic lymphocytic leukemia (CLL) patients likely to have a poor outcome after receiving frontline chemoimmunotherapy. Interim results from the phase III German CLL M1 study presented...
ASH 2016: CD19-Targeting CAR T-Cell Immunotherapy Yields High Response Rates in Treatment-Resistant CLL
In a small, early phase trial, a high percentage of patients who had exhausted most traditional treatments for chronic lymphocytic leukemia (CLL) saw their tumors shrink or even disappear after an infusion of a highly targeted, experimental chimeric antigen receptor (CAR) T-cell immunotherapy...
Smita Bhatia, MD, MPH, and Jessica Wu, BA, on CML: A Report From the Bone Marrow Transplant Survivor Study
Smita Bhatia, MD, MPH, and Jessica Wu, BA, both of the University of Alabama at Birmingham, discuss long-term morbidity and mortality experienced by chronic myeloid leukemia patients after allogeneic hematopoietic cell transplantation (Abstract 823).
Syed A. Abutalib, MD, and Nelli Bejanyan, MD, on Adult ALL and Consolidation Chemotherapy: Results From a CIBMTR Study
Syed A. Abutalib, MD, of Cancer Treatment Centers of America, and Nelli Bejanyan, MD, of the University of Minnesota, discuss findings from a study conducted by the Center for International Blood and Marrow Transplant Research on treatment for ALL patients, with an available donor, undergoing...
Andrew D. Zelenetz, MD, on CLL: Emerging Treatments
Andrew D. Zelenetz, MD, of the Memorial Sloan Kettering Cancer Center, discusses novel treatments for chronic lymphocytic leukemia, touching specifically on the Gilead 115 trial.
Jose F. Leis, MD, PhD, and Sagar Lonial, MD, on CLL: Ibrutinib Insights
Jose F. Leis, MD, PhD, of the Mayo Clinic, and Sagar Lonial, MD, of Emory University, discuss a session on CLL treatment (excluding transplantation): ibrutinib resistance, transformation, and cellular therapy.
ASH 2016: Patients With CML and Stable Molecular Responses May Be Able to Safely Decrease the Dose of Their Tyrosine Kinase Inhibitor
A study led by researchers at the University of Liverpool presented by Clark et al at the 58th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 938) suggests many patients with chronic myeloid leukemia (CML) may be able to safely reduce tyrosine kinase inhibitor side...
ASH 2016: Cessation of Tyrosine Kinase Inhibitor Treatment in Chronic Myeloid Leukemia Patients With Deep Molecular Response
In one of the largest-ever trials to assess the safety of stopping tyrosine kinase inhibitor therapy—the Euro-Ski trial—about half of 821 patients with chronic myeloid leukemia (CML) showed no evidence of relapse 2 years after treatment cessation, suggesting that some patients can...
ASH 2016: Phase I Trial of Vadastuximab Talirine in Combination With 7+3 Induction Therapy for Patients With AML
In a clinical trial presented by Erba et al at the 58th American Society of Hematology (ASH) AnnualMeeting & Exposition (Abstract 211), vadastuximab talirine was found to be safe when used in combination with standard chemotherapy treatment for patients with acute myeloid leukemia (AML). The...
ASH 2016: Study Shows Patients Traditionally Ineligible for Studies May Benefit From Trial Participation
Patients who potentially could benefit most from participation in clinical trials due to poor prognoses often are not included based on eligibility criteria, such as existing medical illnesses. A novel study at The University of Texas MD Anderson Cancer Center revealed some patients with acute...
