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leukemia

Positive Results from Phase III MURANO Trial Evaluating Venetoclax in Combination With Rituximab in Relapsed/Refractory CLL

The phase III MURANO study of venetoclax (Venclexta) tablets in combination with rituximab (Rituxan) met its primary endpoint. Results showed that the combination prolonged progression-free survival in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) compared with bendamustine...

leukemia

Combination of Inotuzumab Ozogamicin and Low-Intensity Chemotherapy in Relapsed or Refractory Ph-Negative ALL

In a single-center phase II trial reported in JAMA Oncology, Jabbour et al found that the combination of inotuzumab ozogamicin (Besponsa) and low-intensity chemotherapy produced promising results in patients with relapsed or refractory Philadelphia chromosome (Ph)-negative acute lymphoblastic...

leukemia

Guadecitabine in Treatment-Naive Older Patients With Acute Myeloid Leukemia

The results of a phase II trial have shown high activity of guadecitabine, a next-generation hypomethylating drug, in treatment-naive older patients with acute myeloid leukemia. The findings were reported in The Lancet Oncology by Kantarjian et al. Guadecitabine has a longer half-life and exposure...

leukemia

FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...

leukemia

FDA Approves First CAR T-Cell Therapy for Pediatric and Young Adult Patients With B-Cell Precursor ALL

Today, the U.S. Food and Drug Administration (FDA) issued what it has called a “historic action,” making the first gene therapy available in the United States. The FDA approved tisagenlecleucel (Kymriah) for certain pediatric and young adult patients with a form of acute lymphoblastic...

hematologic malignancies
leukemia

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....

leukemia

Arsenic Trioxide and Reduced Anthracycline Dose in Pediatric Acute Promyelocytic Leukemia

In the phase III historically controlled Children’s Oncology Group (COG) AAML0631 trial, arsenic trioxide consolidation permitted the use of lower-dose anthracycline without appearing to compromise outcomes in pediatric patients with acute promyelocytic leukemia (APL). The results were...

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

End-of-Life Care for Older Patients With Acute Myeloid Leukemia

As reported in the Journal of Clinical Oncology by Wang et al, many older patients with acute myeloid leukemia (AML) do not receive hospice care at the end of life, with those who do tending to enroll in hospice within days of death. Study Details The population-based retrospective cohort study...

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

Asparaginase-Associated Pancreatitis in Childhood Acute Lymphoblastic Leukemia

An observational study reported in The Lancet Oncology by Wolthers et al in the Ponte di Legno Toxicity Working Group identified characteristics and the course of asparaginase-associated pancreatitis in childhood acute lymphoblastic leukemia. Study Details The study involved merged data from...

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

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, ...

leukemia

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...

leukemia

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...

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...

leukemia

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....

leukemia

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...

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

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...

leukemia

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...

leukemia

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...

leukemia

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 = ...

leukemia

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...

leukemia

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...

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

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...

leukemia

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....

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

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...

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...

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