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leukemia

FDA Approves Inotuzumab Ozogamicin for Relapsed or Refractory B-Cell Precursor ALL

On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). INO-VATE ALL The approval was based on data from INO-VATE ALL, a randomized (1:1), ...

leukemia

FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Some Types of Poor-Prognosis AML

On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related...

leukemia

FDA Approves Enasidenib in Relapsed or Refractory Acute Myeloid Leukemia

Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...

leukemia

FDA 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...

leukemia

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...

leukemia

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...

leukemia

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...

hematologic malignancies
leukemia
lymphoma
myelodysplastic syndromes

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...

leukemia

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 ...

leukemia

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...

leukemia
lymphoma

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...

leukemia

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...

leukemia

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...

leukemia
lymphoma

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...

leukemia

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...

hematologic malignancies
leukemia

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...

leukemia
issues in oncology

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...

leukemia

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...

leukemia

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...

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,...

leukemia
lymphoma

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 ...

leukemia

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...

leukemia

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).

leukemia

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).

leukemia

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).

leukemia

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).

leukemia

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...

leukemia

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).

leukemia

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).

leukemia

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...

leukemia

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...

leukemia
survivorship

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).

leukemia

Syed A. Abutalib, MD, and Nelli Bejanyan, MD, on Adult ALL and Consolidation Chemotherapy: Results From a CIBMTR Study

Syed A. Abutalib, MD, of the 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...

leukemia

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.

leukemia

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.

leukemia

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...

leukemia

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...

leukemia

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...

hematologic malignancies
leukemia
issues in oncology

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...

leukemia

ASH 2016: Biomarker May Predict Which Patients Previously Treated for Cancer Will Develop Highly Fatal Form of Leukemia

Patients successfully treated for breast, colon, and other cancers can go on to develop an often-fatal form of leukemia, sometimes years after completion of treatment, due to a genetic mutation leading to secondary malignancies known as therapy-related myeloid neoplasms. A study conducted by...

leukemia

ASH 2016: New CAR T-Cell Therapy Holds Promise for Children and Young Adults With Hard-to-Treat ALL in Phase I Trial

Children and young adults with relapsed or refractory acute lymphoblastic leukemia (ALL) who receive chimeric antigen receptor (CAR) T-cell therapy targeting CD22, a protein found on the surface of leukemic cells, appear to mount a clinical response and, in some cases, achieve remission....

leukemia

ASH 2016: New Chemotherapy Delivery Method Improves Survival After Bone Marrow Transplant in Older Patients With AML

A new analysis presented by Lancet et al at the 58th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 906) found older patients with acute myeloid leukemia (AML) survived longer after receiving an allogeneic stem cell transplant if they were first treated with the...

leukemia

FDA Grants Full Approval and Label Update for Ponatinib in CML and ALL

The U.S. Food and Drug Administration (FDA) has granted ponatinib (Iclusig) full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) for whom no ...

leukemia

Study Describes Genetic Model of Pro-B ALL

After nearly 2 decades of unsuccessful attempts, researchers from the University of Chicago Medicine and the Cincinnati Children's Hospital Medical Center have created the first mouse model for the most common form of infant leukemia. Their discovery, reported by Lin et al in Cancer Cell, could...

leukemia

Researchers Reveal Genomic Landscape of Core-Binding Factor Acute Myeloid Leukemia

An international team of researchers from the St. Jude Children’s Research Hospital–Washington University Pediatric Cancer Genome Project has completed a detailed map of the genomic landscape for core-binding factor acute myeloid leukemia (CBF-AML). The work reveals differences in the...

leukemia

Early Studies Examine Response of CML-Initiating Cells to Ezh2 Inhibition

Although targeted drugs like imatinib (Gleevec) have revolutionized the treatment of chronic myelogenous leukemia (CML), patients generally must take them for the rest of their lives and may cease benefiting from them over time. New research conducted by scientists at Dana-Farber Cancer Institute...

leukemia
issues in oncology

Adolescent Girls With Leukemia May Not Be Screened for Pregnancy Before Beginning Chemotherapy

A new study indicates that adolescent females with acute leukemia have low rates of pregnancy screening prior to receiving chemotherapy that can cause birth defects. These findings were published by Rao et al in Cancer. Although many chemotherapy drugs can cause birth defects, there are no...

leukemia

FDA Approves Blinatumomab for Use in Pediatric Patients With Ph-Negative Relapsed or Refractory B-Cell Precursor ALL

The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome (Ph)-negative relapsed or refractory B-cell precursor acute...

leukemia

FDA Approves Ofatumumab in Combination With Fludarabine and Cyclophosphamide for Relapsed CLL

Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for the use of ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia...

leukemia

Study Evaluates Chronic Graft-vs-Host Disease Burden and Complications in Patients Receiving Bone Marrow Transplants

A University of Colorado Cancer Center study compared outcomes of leukemia patients receiving bone marrow transplants from 2009 to 2014, finding that 3 years post transplant, the incidence of severe chronic graft-vs-host disease was significantly higher in patients who had received transplants from ...

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