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Leukemia
Issues in Oncology

ASH 2019: Should African American Patients With AML and Evidence of Abnormal Kidney Function Be Enrolled Into Clinical Trials?

A study of more than 1,000 patients with acute myeloid leukemia (AML) revealed that African Americans were more likely to have evidence of abnormal kidney functioning than whites, but this was not associated with any difference in overall survival. The findings, presented by Statler et al at the...

Leukemia
Genomics/Genetics

ASH 2019: Genomic Features of AML in Patients Aged 60 or Older May Predict Stem Cell Transplant Outcome

For older patients with acute myeloid leukemia (AML), the prospects for success of a stem cell transplant can often be predicted based on the particular set of leukemic genetic characteristics, according to results presented by Murdock et al at the 2019 American Society of Hematology (ASH) Annual...

leukemia

Tait D. Shanafelt, MD, on CLL in Younger Patients: Comparing Ibrutinib and Rituximab With FCR

Tait D. Shanafelt, MD, of Stanford University, discusses extended follow-up data that show ibrutinib plus rituximab improved clinical outcomes vs the standard therapy of fludarabine/cyclophosphamide/ rituximab in younger patients with previously untreated chronic lymphocytic leukemia (Abstract 33).

leukemia

Mhairi Copland, PhD, MB BChir, on Blast Phase CML: A Possible Treatment Advance

Mhairi Copland, PhD, MB BChir, of the University of Glasgow, discusses results of a study on the combination of ponatinib and fludarabine, cytarabine, idarubicin, and G-CSF for patients with blast phase chronic myeloid leukemia, a rare complication with a poor outcome (Abstract 497).

leukemia

Nitin Jain, MD, on First-Line Ibrutinib Plus Venetoclax in CLL

Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses findings from two studies showing that the combination of ibrutinib and venetoclax is an effective chemotherapy-free oral regimen for patients with high-risk, previously untreated chronic lymphocytic leukemia (Abstract 34).

myelodysplastic syndromes
leukemia

Mikkael A. Sekeres, MD, on Newly Diagnosed Hematologic Malignancies: Early Trial Findings on Glasdegib Plus Azacitidine

Mikkael A. Sekeres, MD, of the Cleveland Clinic, discusses results of a phase Ib study of glasdegib in combination with azacitidine, which showed activity in patients with untreated myelodysplastic syndromes, acute myeloid leukemia, and chronic myelomonocytic leukemia who are ineligible for intensive chemotherapy (Abstract 177).

Leukemia
Issues in Oncology

ASH 2019: Lower Area-Based Income and Educational Attainment Associated With Poorer Survival Among Pediatric Patients With AML

Children from lower-income neighborhoods were 2.4 times more likely to die during treatment for acute myeloid leukemia (AML) than children from middle- and high-income neighborhoods, according to findings from a study that analyzed nearly 1,500 clinical trial participants. While previous research...

Leukemia

Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia

In late 2018, calaspargase pegol-mknl, an asparagine-specific enzyme, was approved for use as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to 21 years.1,2 The new product provides for a longer interval ...

Leukemia

Glasdegib in Older Patients With AML or Those With Comorbidities

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Late in 2018, the Hedgehog pathway inhibitor glasdegib...

Leukemia
Lymphoma

FDA Approves Acalabrutinib for CLL/SLL as Part of Project Orbis

On November 21, as part of Project Orbis—a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada—the U.S. Food and Drug Administration (FDA) granted supplemental approval to acalabrutinib (Calquence) for the treatment of adults with chronic lymphocytic leukemia...

Leukemia

Late Bone Marrow Relapse Risk Stratification in Pediatric Patients With B-Cell Acute Lymphoblastic Leukemia

In an analysis of the German ALL-REZ BFM 2002 trial, reported in the Journal of Clinical Oncology, Eckert et al found that postinduction minimal residual disease (MRD)-based treatment stratification resulted in “excellent survival” in pediatric patients with late relapse of B-cell precursor acute...

Issues in Oncology
Hematologic Malignancies
Leukemia

How Clonal Hematopoiesis of Indeterminate Potential Increases the Risk of Heart Disease and Blood Cancers as People Age

Although stem cells throughout the body acquire genetic mutations over time, usually these alterations do not affect how the stem cells function or cause disease. However, recent research in clonal hematopoiesis and aging has found an association between clonal expansion of hematopoietic cells with ...

Leukemia
Lymphoma

Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

On May 15, 2019, venetoclax was approved for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 Supporting Efficacy Data Approval was based on findings from the open-label phase III CLL14 trial (ClinicalTrials.gov...

Leukemia

ADMIRAL: Gilteritinib vs Chemotherapy in Relapsed or Refractory FLT3-Mutated AML

As reported in The New England Journal of Medicine by Perl et al, the phase III ADMIRAL trial showed improved overall survival with the oral FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib vs salvage chemotherapy in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia...

Leukemia

Asciminib/Imatinib in Patients With Previously Treated CML

In a phase I trial, the combination of the BCR-ABL1 inhibitor asciminib and the small-molecule kinase inhibitor imatinib showed preliminary efficacy, safety, and tolerability in patients with chronic myeloid leukemia (CML) resistant to or intolerant of treatment with two or more prior tyrosine...

Breast Cancer
Leukemia
Prostate Cancer
Lymphoma

FDA Pipeline: Treatments for HER2-Positive Breast Cancer, AML; Breakthrough Device for Prostate Cancer; Statement on Safety Information for Breast Implants

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to trastuzumab deruxtecan for the treatment of HER2-positive metastatic breast cancer; granted Fast Track designation for bemcentinib for elderly patients with relapsed acute myeloid leukemia (AML); granted Breakthrough...

Leukemia
Genomics/Genetics
Immunotherapy

Gene Signature to Identify Benefit of Front-Line Fludarabine, Cyclophosphamide, and Rituximab in IGHV-Unmutated CLL

In a retrospective cohort study reported in The Lancet Oncology, Herling et al identified a 17-gene signature that distinguished patients with IGHV-unmutated chronic lymphocytic leukemia (CLL) more likely to achieve long-term remission after front-line chemoimmunotherapy with fludarabine,...

Immunotherapy
Leukemia

Debating the Role of Chemoimmunotherapy in the First-Line Setting of CLL

The advent of new targeted agents for chronic lymphocytic leukemia (CLL) has ushered in a golden age of treatment, leading to longer, more durable periods of disease control. Not all oncologists are convinced, however, that improvements in progression-free survival alone warrant dispensing with...

leukemia
immunotherapy

Nitin Jain, MD, on CLL: Is There a Role for Chemoimmunotherapy?

Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses the debate on evolving strategies in first-line treatment of CLL.

leukemia
immunotherapy

William G. Wierda, MD, PhD, on Evolving Strategies for First-Line Treatment of CLL

William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, offers commentary on the debate about evolving strategies in first-line chronic lymphocytic leukemia, the clinical trials on such agents as ibrutinib, BTK inhibitors, and venetoclax, and the interest in chemoimmunotherapy as a fixed duration treatment.

Prostate Cancer
Bladder Cancer
Hematologic Malignancies
Breast Cancer
CNS Cancers
Leukemia
Skin Cancer

FDA Pipeline: Advances in Prostate Cancer, Urothelial Cancer, Myelofibrosis, and More

In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions in prostate cancer, urothelial cancer, myelofibrosis, breast cancer, pediatric brain cancer, leukemia, and skin cancer. Breakthrough Therapy Designation for Niraparib in Metastatic...

Leukemia

SOHO 2019: Asciminib/Imatinib in Patients With Previously Treated CML

In a phase I trial, the combination of the BCR-ABL1 inhibitor asciminib and the small-molecule kinase inhibitor imatinib showed preliminary efficacy, safety, and tolerability in patients with chronic myeloid leukemia (CML) resistant to or intolerant of treatment with two or more prior tyrosine...

Leukemia

Having Cancer as a Teenager Derailed My Life Course

In 1994, I was a normal, active 15-year-old, who loved cars, sports, and rock music, especially songs from my favorite group, The Clash. In fact, it was while jubilantly dancing alone in my room to one of their tunes that I vomited into my hands, an early symptom of acute myeloid leukemia (AML). I...

Myelodysplastic Syndromes
Leukemia
Lung Cancer
Solid Tumors
Colorectal Cancer
Hepatobiliary Cancer

FDA Pipeline: Fast Track Designation in Myelodysplastic Syndrome and AML, Plus Multiple Breakthrough Designations

Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...

Leukemia
Survivorship

Risk of Infections in Survivors of Childhood Leukemia

In a study reported in the Journal of Clinical Oncology, Pelland-Marcotte et al found that survivors of childhood leukemia remained at significantly increased risk of infection compared with matched controls during an extended period following completion of treatment.   Study Details The...

Genomics/Genetics
Leukemia

Chromosomal Abnormalities and Prognosis in NPM1-Mutant AML

In a study reported in the Journal of Clinical Oncology, Angenendt et al found that adverse-risk cytogenetics were associated with significantly poorer outcomes vs normal karyotype among patients with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. As stated by the...

leukemia
prostate cancer
gastrointestinal cancer

FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance

Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...

leukemia
immunotherapy

Ibrutinib/Rituximab vs Standard Chemoimmunotherapy in Previously Untreated CLL

In an interim analysis of the phase III E1912 trial reported in The New England Journal of Medicine, Shanafelt et al found that ibrutinib/rituximab improved progression-free and overall survival vs standard chemoimmunotherapy in patients 70 years old or younger with previously untreated chronic...

leukemia
lung cancer
sarcoma
immunotherapy

FDA Pipeline: Label Update for Durvalumab in NSCLC; Applications Accepted in Epithelioid Sarcoma, AML

Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...

Hematologic Malignancies
Leukemia

Active Regimen for High-Risk and Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

In a single-center phase II trial reported in The New England Journal of Medicine, Nitin Jain, MD, and colleagues found that the combination of ibrutinib and venetoclax was highly active in previously untreated high-risk and older patients with chronic lymphocytic leukemia (CLL).  In the study, 80 ...

leukemia
lymphoma

FDA Approves Rituximab Biosimilar for Non-Hodgkin Lymphoma, CLL, and Autoimmune Conditions

Today, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangiitis....

leukemia

CLARITY: Ibrutinib Plus Venetoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia

In the phase II CLARITY trial reported in the Journal of Clinical Oncology, Hillmen et al found that the combination of ibrutinib and venetoclax resulted in high rates of minimal residual disease eradication in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In the...

leukemia
survivorship

Anesthesia Exposure and Neurocognitive and Neuroimaging Outcomes in Long-Term Survivors of Childhood ALL

In a study reported in JAMA Oncology, Banerjee et al found that higher cumulative anesthesia exposure and duration of exposure during treatment of childhood acute lymphoblastic leukemia (ALL) may be associated with adverse neurocognitive and abnormal neuroimaging outcomes in long-term survivors....

leukemia

Substitution of Clofarabine for Anthracycline/Etoposide in Induction Therapy for Pediatric Acute Myeloid Leukemia

In the phase III AML08 trial reported in the Journal of Clinical Oncology, Rubnitz et al found that the use of clofarabine instead of an anthracycline and etoposide in the first course of induction therapy may be a feasible strategy in pediatric patients with acute myeloid leukemia. The trial,...

Leukemia

FDA Approves First-Line Ivosidenib for IDH1-Mutated AML

On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...

Leukemia
Immunotherapy

Fixed-Duration Venetoclax Plus Obinutuzumab as First-Line Treatment in Older Patients With CLL Who Have Comorbidities

A fixed-duration regimen of venetoclax plus obinutuzumab demonstrated superior progression-free survival, complete response rates, and minimal residual disease (MRD) negativity compared with chlorambucil plus obinutuzumab as first-line therapy for older patients with chronic lymphocytic leukemia...

Hematologic Malignancies
Leukemia

New NCCN Guidelines for Pediatric Acute Lymphoblastic Leukemia

Recently, the National Comprehensive Cancer Network® (NCCN®) debuted the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pediatric Acute Lymphoblastic Leukemia (ALL)—the most comprehensive and up-to-date, evidence-based, consensus-driven guidelines for treating children with...

leukemia

Association of Antibodies With Pegaspargase Allergic Reactions and Failure of Rechallenge in Pediatric ALL

In a study reported in the Journal of Clinical Oncology, Liu et al determined the frequency of allergic reactions and consequences of development of antibodies to pegaspargase (PEG-ASP) among pediatric patients with newly diagnosed acute lymphoblastic leukemia (ALL).    As noted by the...

leukemia
immunotherapy

EHA 2019: ASCEND Trial Compares Acalabrutinib vs Investigator’s Choice in Relapsed or Refractory CLL

The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...

leukemia

EHA 2019: CLL12 Trial Investigates Ibrutinib in Previously Untreated, Asymptomatic Early-Stage CLL

At the 24th Annual Congress of the European Hematology Association (EHA), Langerbeins et al presented findings from the phase III CLL12 trial, which evaluated whether ibrutinib prolongs event-free survival in patients with previously untreated, Binet stage A chronic lymphocytic leukemia (CLL)...

leukemia

QuANTUM-R: Quizartinib vs Salvage Chemotherapy in Relapsed or Refractory FLT3-ITD–Positive AML

In the phase III QuANTUM-R trial reported in The Lancet Oncology, Cortes et al found that the FLT3 inhibitor quizartinib produced a modest but significant improvement in overall survival vs salvage chemotherapy in relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute...

leukemia

François-Xavier Mahon, MD, PhD, on Chronic-Phase Chronic Myeloid Leukemia: Treatment-Free Remission After Second-Line Treatment

François-Xavier Mahon, MD, PhD, of the Université Bordeaux and Institut Bergonie, discusses results of the ENESTop study, which demonstrated the long-term durability and safety of treatment-free remission in chronic-phase CML after second-line nilotinib (Abstract 7005).

leukemia
immunotherapy

2019 ASCO: CLL14 Trial Evaluates First-Line Venetoclax/Obinutuzumab in Previously Untreated CLL

The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...

leukemia

First-Line Ibrutinib and Venetoclax for High-Risk and Older Patients With Previously Untreated CLL

In a single-center phase II trial reported in The New England Journal of Medicine, Jain et al found that the combination of ibrutinib and venetoclax was highly active in previously untreated high-risk and older patients with chronic lymphocytic leukemia (CLL).  In the study, 80 patients...

leukemia

Kerry A. Rogers, MD, on Chronic Lymphocytic Leukemia: Acalabrutinib With Obinutuzumab in Treatment-Naive and Relapsed or Refractory Disease

Kerry A. Rogers, MD, of The Ohio State University, discusses a 3-year follow-up of phase Ib safety and efficacy findings with the selective BTK inhibitor acalabrutinib and the anti-CD20 monoclonal antibody obinutuzumab in patients with CLL (Abstract 7500).  

leukemia
lymphoma
immunotherapy

William G. Wierda, MD, PhD, on Immunotherapy for Relapsed/Refractory CLL/SLL: Results From TRANSCEND CLL 004

William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the TRANSCEND CLL 004 trial, which studied the use of an experimental CD19-directed CAR T-cell product in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (Abstract 7501).

leukemia

Mark J. Levis, MD, PhD, on Acute Myeloid Leukemia: Gilteritinib in FLT3-Mutated Disease

Mark J. Levis, MD, PhD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, discusses the effect of gilteritinib on survival in patients with FLT3-mutated relapsed/refractory AML who have common co-mutations or a high FLT3-ITD allelic ratio, and the importance of FLT3-ITD testing at diagnosis and again at relapse (Abstract 7000).

leukemia

FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory FLT3-Mutated AML

On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved...

Hematologic Malignancies
Leukemia
Lymphoma

FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL

On May 15, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on the CLL14...

Hematologic Malignancies
Leukemia

FDA Approves First-Line Ivosidenib for IDH1-Mutated AML

On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...

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