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Leukemia
Immunotherapy

Dasatinib/Blinatumomab Produces High Rates of Molecular Response and Survival in Philadelphia Chromosome–Positive ALL

In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Robin Foà, MD, of Sapienza University of Rome, and colleagues, found that first-line induction and consolidation treatment with dasatinib and blinatumomab produced a high rates of molecular response as...

Leukemia

Venetoclax in Combination Therapy for Untreated Acute Myeloid Leukemia

On October 16, 2020, venetoclax was granted regular approval for use in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or those with comorbidities precluding intensive induction...

Leukemia
Immunotherapy

4-Year Findings From MURANO Trial: Venetoclax Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia

As reported in the Journal of Clinical Oncology by Arnon P. Kater, MD, PhD, of Amsterdam University Medical Centers, and colleagues,1 the 4-year progression-free and overall survival rates were significantly higher with venetoclax plus rituximab vs bendamustine plus rituximab in the phase III...

Leukemia

Final ASCEND Results Confirm Acalabrutinib as a Standard for Relapsed CLL

The Bruton’s tyrosine kinase (BTK) inhibitors have been one of the most exciting advances in the treatment of patients with chronic lymphocytic leukemia (CLL) and have led to the development of chemotherapy-free treatments for both treatment-naive as well as relapsed or refractory CLL based on...

Leukemia
Immunotherapy

Acalabrutinib Improves Progression-Free Survival vs Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory CLL

As reported in the Journal of Clinical Oncology by Paolo Ghia, MD, PhD, of the Università Vita-Salute San Raffaele, Milan, Italy, and colleagues, the phase III ASCEND trial showed significantly prolonged progression-free survival with acalabrutinib monotherapy vs investigator’s choice of either...

Leukemia
Lymphoma
Multiple Myeloma
Immunotherapy

Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies

Daratumumab and hyaluronidase-fihj: On May 1, 2020, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex) for adult patients with newly diagnosed or relapsed or refractory multiple myeloma. Ibrutinib: On April 21, 2020, the FDA expanded the indication of ibrutinib (Imbruvica) to include...

Leukemia
Lymphoma
Multiple Myeloma
Immunotherapy

Novel Therapies and New Indications for Use in Treatment of Hematologic Malignancies

Venetoclax: On October 16, 2020, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older. See page 32 for more on this approval....

Hematologic Malignancies
Multiple Myeloma
Lymphoma
Leukemia
Immunotherapy

Hematologic Oncology Highlights 2019–2020 Almanac

The past year has seen remarkable advances in the treatment of leukemia, lymphoma, and multiple myeloma, which combined account for 9.9% of the estimated 1,806,590 new cases of cancer diagnosed in the United States and an estimated 56,840 cancer-related deaths.1 Novel therapies are providing...

Leukemia

Venetoclax Combination in Newly Diagnosed AML

On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged 75 or older or who have comorbidities precluding...

Leukemia

ASH Releases New Clinical Practice Guidelines on Treatment of Older Adults With Newly Diagnosed Acute Myeloid Leukemia

The American Society of Hematology (ASH) has published new guidelines to help older adults with acute myeloid leukemia (AML) and their health-care providers make critical care decisions, including if and how to proceed with cancer treatment and the need for blood transfusions for those in hospice...

Leukemia

Optimizing the Treatment of Adults With Acute Lymphoblastic Leukemia

In the treatment of adults with acute lymphoblastic leukemia (ALL), use of newer antibodies and de-intensification of chemotherapy have greatly improved outcomes, according to Hagop Kantarjian, MD, FASCO, who has been very involved in much of the research in ALL treatment. Dr. Kantarjian, Professor ...

Leukemia

Effects of Stopping Tyrosine Kinase Inhibitor Treatment for Chronic Myeloid Leukemia

In a study (Life After Stopping TKIs; LAST) reported in JAMA Oncology, Atallah et al found that stopping tyrosine kinase inhibitor (TKI) therapy in patients with controlled chronic myeloid leukemia (CML) was associated with maintenance of major molecular response and achievement of treatment-free...

Leukemia

Addition of Venetoclax to Bortezomib/Dexamethasone in Relapsed or Refractory Multiple Myeloma: BELLINI Trial

As reported in The Lancet Oncology by Shaji K. Kumar, MD, and colleagues, the phase III BELLINI trial has shown that the addition of venetoclax to bortezomib/dexamethasone significantly prolonged progression-free survival in patients with relapsed or refractory multiple myeloma but was associated...

Leukemia

Ivosidenib Plus Azacitidine in Newly Diagnosed IDH1-Mutant Acute Myeloid Leukemia

In a phase Ib study reported in the Journal of Clinical Oncology, Courtney D. DiNardo, MD, and colleagues found that the combination of ivosidenib and azacitidine produced a high response rate in patients with newly diagnosed isocitrate dehydrogenase 1 (IDH1)-mutant acute myeloid leukemia...

Leukemia

Comanagement of Induction Therapy for Acute Promyelocytic Leukemia by Experts and Community Practices

In a study reported in JCO Oncology Practice, Anand P. Jillella, MD, and colleagues found that physician education on the main causes of death during induction treatment for acute promyelocytic leukemia (APL)—and comanagement of cases with expert physicians—resulted in a low early mortality rate...

Leukemia

rhG-CSF and Decitabine to Reduce Risk of Relapse in Patients With AML After Stem Cell Transplant

In a Chinese phase II trial reported in the Journal of Clinical Oncology, Gao et al found that prophylactic recombinant human granulocyte colony-stimulating factor (rhG-CSF) and minimal-dose decitabine reduced the risk of relapse vs no intervention among patients with high-risk, minimal residual...

Leukemia

Chronic Lymphocytic Leukemia: New Treatments Achieve Deeper Remissions

At the National Comprehensive Cancer Network® (NCCN®) 2020 Virtual Congress: Hematologic Malignancies, William Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, reviewed current data on chronic lymphocytic leukemia (CLL), including promising new combinations of modern...

Immunotherapy
Leukemia
Lymphoma

Bispecific Anti-CD20/Anti-CD19 CAR T Cells for Patients With Relapsed B-Cell Malignancies

In a single-institution phase I dose-escalation and -expansion trial reported as a letter in Nature Medicine, Shah et al found that treatment with tandem bispecific anti-CD20/anti-CD19 4-1BB–CD3ζ lentiviral (LV20.19) chimeric antigen receptor (CAR) T cells produced high response rates in adult...

Leukemia

Predicting Mortality Outcomes After Intensive Chemotherapy for AML

In a single-institution study reported in the Journal of Clinical Oncology, Palmieri et al found that the Ferrara criteria for determining fitness for intensive chemotherapy—a set of consensus criteria proposed by a panel of experts from the Italian Society of Hematology, Italian Society of...

Leukemia

First-in-Human Study of LSD1 Inhibitor Iadademstat for Patients With Relapsed or Refractory AML

In a first-in-human phase I trial reported in the Journal of Clinical Oncology, Salamero et al identified toxicities and activity associated with iadademstat, an oral first-in-class lysine-specific histone demethylase 1A (LSD1) inhibitor, in patients with relapsed or refractory acute myeloid...

Leukemia
Immunotherapy

First-Line Dasatinib Plus Blinatumomab for Adult Patients With Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia

In an Italian phase II trial (GIMEMA LAL2116) reported in The New England Journal of Medicine, Foà et al found that first-line induction and consolidation treatment with dasatinib plus blinatumomab produced a high rate of molecular response in adults with Philadelphia chromosome–positive acute...

Hematologic Malignancies
Leukemia

Preliminary Progress with Genetically Engineered T Cells in Treating Childhood ALL 

Two small phase I studies at separate centers demonstrated encouraging results in the treatment of children with acute lymphoblastic leukemia (ALL) using reinfused autologous genetically engineered T cells. Results of both studies were presented at the Annual Meeting of the American Association for ...

Lung Cancer
Kidney Cancer
Leukemia
Solid Tumors
Gastroesophageal Cancer
Gastrointestinal Cancer
Pancreatic Cancer
Prostate Cancer
Genomics/Genetics
Immunotherapy

FDA Pipeline: Priority Reviews in EGFR-Mutant Lung Cancer, Advanced Renal Cell Carcinoma; Fast Track Designations in CLL and Solid Tumors

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....

Leukemia

Association of Minimal Residual Disease With Disease-Free and Overall Survival in Patients With AML

In a systematic review and meta-analysis reported in JAMA Oncology, Nicholas J. Short, MD, and colleagues found that minimal (or measurable) residual disease (MRD) negativity is associated with superior disease-free and overall survival in patients with acute myeloid leukemia (AML). As stated by...

Leukemia
Geriatric Oncology

FDA Approves Venetoclax Combination Regimen for Certain Adult Patients With AML

On October 16, the U.S. Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults age 75 or older or who have comorbidities precluding intensive ...

Leukemia

Prognostic Model for Outcomes With Ibrutinib Treatment for Chronic Lymphocytic Leukemia

As reported in the Journal of Clinical Oncology, Ahn et al developed a four-factor model that identified risk groups for poorer outcomes among patients treated with ibrutinib for chronic lymphocytic leukemia. Study Details Patients treated with ibrutinib in phase II and III trials constituted the...

Leukemia

Addition of Nelarabine to Standard Therapy Improves Disease-Free Survival in Newly Diagnosed T-Cell ALL

As reported in the Journal of Clinical Oncology by Kimberly P. Dunsmore, MD, of the Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, and colleagues, the phase III Children’s Oncology Group AALL0434 trial has shown that the addition of nelarabine to standard therapy improved...

Leukemia
Immunotherapy

Four-Year Findings From the MURANO Trial: Venetoclax Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia

As reported in the Journal of Clinical Oncology by Kater et al, 4-year progression-free and overall survival were significantly greater with venetoclax plus rituximab vs bendamustine plus rituximab in the phase III MURANO trial in patients with relapsed or refractory chronic lymphocytic leukemia....

Leukemia

Addition of Venetoclax to Azacitidine in Acute Myeloid Leukemia

In the phase III VIALE-A trial reported in The New England Journal of Medicine, Courtney D. DiNardo, MD, MSCE, of The University of Texas MD Anderson Cancer Center, and colleagues found that venetoclax plus azacitidine significantly improved overall survival vs azacitidine alone in previously...

Leukemia

Azacitidine Tablets for Continued Treatment in Acute Myeloid Leukemia

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. On September 1, 2020, azacitidine tabletswere approved...

Prostate Cancer
CNS Cancers
Leukemia

FDA Pipeline: Designations in Prostate Cancer, Glioblastoma, and Pediatric Leukemia

Recently, the U.S. Food and Drug Administration (FDA) granted designations to agents for metastatic castration-resistant prostate cancer, recurrent glioblastoma, and pediatric acute myeloid leukemia. Fast Track Designation for EPI-7386 in Metastatic Castration-Resistant Prostate Cancer The FDA...

Leukemia
Immunotherapy

Dr. Kantarjian Shares His Thoughts on Optimizing the Treatment of Adults With ALL

In the treatment of adults with acute lymphoblastic leukemia (ALL), use of newer antibodies and de-intensification of chemotherapy have greatly improved outcomes, according to Hagop ­Kantarjian, MD, who has been very involved in much of the research in ALL treatment. Dr. Kantarjian, Professor and...

Leukemia
Genomics/Genetics

Role of Inherited GATA3 Variant in Response to Treatment, Disease Relapse in Pediatric ALL

Research published by Zhang et al in the Journal of the National Cancer Institute showed that an inherited variation in the GATA3 gene strongly influences early response to chemotherapy and is linked to relapse in children with acute lymphoblastic leukemia (ALL).   Minimal residual disease (MRD)...

Multiple Myeloma
Breast Cancer
Lung Cancer
Solid Tumors
Lymphoma
Leukemia
Skin Cancer

FDA Pipeline: Priority Reviews in Multiple Myeloma, Metastatic Breast Cancer, and NSCLC

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents for the treatment of refractory multiple myeloma, metastatic breast cancer, and metastatic non–small cell lung cancer (NSCLC); gave Fast Track designation to treatments for NTRK mutation­–positive solid tumors...

Leukemia
Immunotherapy

CLL14 Trial Follow-up: Venetoclax Plus Obinutuzumab in Previously Untreated Patients With Chronic Lymphocytic Leukemia

As reported in The Lancet Oncology by Al-Sawaf et al, 3-year follow-up of the phase III CLL14 trial showed maintained significant improvement in progression-free survival with the fixed-duration regimen of venetoclax/obinutuzumab vs chlorambucil/obinutuzumab in previously untreated patients with...

Leukemia

FDA Approves Oral Azacitidine as Maintenance Therapy for Adults With AML in First Remission

On September 1, the U.S. Food and Drug Administration (FDA) approved oral azacitidine (Onureg; also known as CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery...

Leukemia

Addition of Nelarabine to Standard Therapy in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia

As reported in the Journal of Clinical Oncology by Dunsmore et al, the phase III Children’s Oncology Group AALL0434 trial has shown that the addition of nelarabine to standard therapy improved disease-free survival in children and young adults with newly diagnosed T-cell acute lymphoblastic...

Leukemia

Obinutuzumab, Ibrutinib, and Venetoclax in Treatment-Naive and Relapsed or Refractory Chronic Lymphocytic Leukemia

In a single-institution phase II trial reported in the Journal of Clinical Oncology, Rogers et al found that the combination of obinutuzumab, ibrutinib, and venetoclax produced high response rates in both treatment-naive and relapsed or refractory chronic lymphocytic leukemia. Study Details A total ...

Leukemia
Lymphoma

Final ASCEND Results Confirm Acalabrutinib as a Standard for Relapsed CLL

The Bruton’s tyrosine kinase (BTK) inhibitors have been one of the most exciting advances in the tre atment of chronic lymphocytic leukemia (CLL) and have led to the development of chemotherapy-free treatments for both treatment-naive as well as relapsed or refractory CLL based on studies where...

Leukemia
Lymphoma

Acalabrutinib Improves Progression-Free Survival vs Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory CLL

As reported in the Journal of Clinical Oncology by Paolo Ghia, MD, PhD, of the Università Vita-Salute San Raffaele, Milan, Italy, and colleagues, the phase III ASCEND trial showed significantly prolonged progression-free survival with acalabrutinib monotherapy vs the investigator’s choice of...

Immunotherapy
Lung Cancer
CNS Cancers
Leukemia
Lymphoma

FDA Pipeline: Priority Reviews for Immunotherapy Dose Regimen, Small Cell Lung Cancer; Fast Track Designations in Brain Cancer and Leukemia

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for a novel dosing regimen for durvalumab as well as for trilaciclib in small cell lung cancer; granted Fast Track designations to treatments for glioblastoma and B-cell acute lymphoblastic leukemia; and issued reports...

Leukemia

Sorafenib Maintenance After Stem Cell Transplant in FLT3-ITD–Positive Acute Myeloid Leukemia

In a Chinese phase III trial reported in The Lancet Oncology, Xuan et al found that sorafenib maintenance after allogeneic hematopoietic stem cell transplantation significantly reduced the risk of relapse vs no maintenance therapy in patients with FLT3–internal tandem duplication (ITD)–positive...

Leukemia

Addition of Venetoclax to Azacitidine in Previously Untreated Patients With AML Ineligible for Induction Therapy

In the phase III VIALE-A trial reported in The New England Journal of Medicine, Courtney D. DiNardo, MD, and colleagues found that venetoclax plus azacitidine significantly improved overall survival vs azacitidine alone in previously untreated patients with acute myeloid leukemia (AML) who were...

Lung Cancer
Genomics/Genetics
Gynecologic Cancers
Leukemia
Lymphoma

FDA Pipeline: Approval for First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic; Designations in Ovarian Cancer, Leukemia, and Lymphoma

Recently, the U.S. Food and Drug Administration (FDA) approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to identify patients with non–small cell lung cancer (NSCLC) and specific types of EGFR mutations. The FDA also granted Fast Track...

Leukemia
Geriatric Oncology

ASH Releases New Clinical Practice Guidelines on the Treatment of Older Adults With Newly Diagnosed Acute Myeloid Leukemia

The American Society of Hematology (ASH) has published new guidelines to help older adults with acute myeloid leukemia (AML) and their health-care providers make critical care decisions, including if and how to proceed with cancer treatment and the need for blood transfusions for those in hospice...

Leukemia
Immunotherapy

Gemtuzumab Ozogamicin in Pediatric Patients With Newly Diagnosed CD33-Positive AML

On June 16, 2020, the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients aged 1 month and older.1,2 Supporting Efficacy Data Approval was supported by findings from the phase III AAML0531 trial...

Leukemia

Refinement of European LeukemiaNet Classification Recommendations for Younger Adults With AML

Findings from a study published by Eisfeld et al in the journal Leukemia could refine an important set of prognostic and treatment recommendations for younger adult patients with acute myeloid leukemia (AML). The retrospective study evaluated the molecular characteristics and outcomes of 863...

Leukemia
Survivorship

Late Morbidity and Mortality in Survivors of Childhood ALL Receiving Contemporary Risk-Stratified Therapy

In an analysis from the Childhood Cancer Survivor Study reported in the Journal of Clinical Oncology, Dixon et al found that 5-year survivors of childhood acute lymphoblastic leukemia (ALL) diagnosed and treated with risk-stratified therapy in the 1990s had reduced morbidity and health-related late ...

Leukemia

Sorafenib Maintenance After Allogeneic HCT in Patients With FLT3-ITD–Positive AML

In the German-Austrian phase II SORMAIN trial reported in the Journal of Clinical Oncology, Burchert et al found that maintenance treatment with sorafenib vs placebo was associated with significantly prolonged relapse-free survival after allogeneic hematopoietic stem cell transplantation (HCT) in...

issues in oncology
leukemia

Alfonso Bencomo Álvarez, PhD, on ALL, AML, and CML: Survival for Hispanic Patients Living Near the US/Mexico Border

Alfonso Bencomo Álvarez, PhD, of Texas Tech University Health Sciences Center, discusses his retrospective study of the incidence and survival for patients with hematologic malignancies residing at the United States/Mexico border. The analysis showed that 10-year survival rates for Hispanic patients with ALL, AML, and CML were significantly lower for those who lived in El Paso than for those who lived elsewhere in Texas (Abstract 4343).

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