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The Samuel Waxman Cancer Research Foundation (SWCRF) announced that Martin S. Tallman, MD, Chief of Leukemia Service at Memorial Sloan Kettering Cancer Center (MSK), has joined its Scientific Advisory Board. Dr. Tallman, who will continue in his role at MSK, will join his fellow Scientific...
A novel approach to chimeric antigen receptor (CAR) T-cell therapy seems to effectively target acute lymphoblastic leukemia (ALL) cells with varying antigen profiles and may help to overcome antigen escape, seen with CD19-targeted therapy. According to data presented at the 2018 ASCO-SITC Clinical...
In an analysis of two pooled studies reported in JAMA Oncology, O’Brien et al found that a complete response to ibrutinib (Imbruvica) in the treatment of chronic lymphocytic leukemia was more likely in patients receiving the agent as first-line therapy and in those without bulky disease....
Researchers at the University of California (UC), Davis, have shown that patients with acute myeloid leukemia (AML) who received their care at a National Cancer Institute (NCI) cancer center in California had a dramatically reduced risk of early mortality. Using data from the California Cancer...
GUEST EDITOR Dr. Abraham is the Director of the Breast Oncology Program at Taussig Cancer Institute, and Professor of Medicine, Lerner College of Medicine, Cleveland Clinic. MATT KALAYCIO, MD Affiliation: Cleveland Clinic Taussig Cancer InstituteOn balancing priorities: “As an oncologist in...
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
As reported in the Journal of Clinical Oncology by Gore et al, a phase II trial has shown high response rates with dasatinib treatment in pediatric patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP). Findings in the trial supported the...
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 December 19, 2017, bosutinib (Bosulif) was granted...
On February 28, Shire announced that the U.S. Food and Drug Administration (FDA) accepted the company’s biologics license application (BLA) for calaspargase pegol (Cal-PEG; SHP663). The investigational-stage compound is being reviewed as a component of a multiagent chemotherapeutic regimen...
The use of maintenance therapy in older patients with acute myeloid leukemia (AML) is theoretically sensible, but its clinical value remains uncertain. The phase III HOVON97 randomized study demonstrated that maintenance therapy with the hypomethylating agent azacitidine may improve disease-free...
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 Hagop M. Kantarjian, MD, of The University of Texas MD Anderson...
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
On February 14, Amgen announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the supplemental biologics license application (sBLA) for blinatumomab (Blincyto) for the treatment of patients with minimal residual disease...
On August 1, 2017, the IDH2 inhibitor enasidenib (Idhifa) was granted regular approval for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...
On July 11, 2017, blinatumomab (Blincyto) was approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.1,2 Blinatumomab received accelerated approval in December 2014 for the treatment of Philadelphia chromosome (Ph)-negative...
Updated results from the ELIANA clinical trial of tisagenlecleucel (Kymriah), formerly CTL019, in relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) have been published by Maude et al in The New England Journal of Medicine. New data include...
In a single-center phase II study reported in The Lancet Oncology, Kantarjian et al found that the addition of inotuzumab ozogamicin (Besponsa) to low-intensity chemotherapy produced promising outcomes in older patients with newly diagnosed Philadelphia chromosome–negative acute lymphoblastic ...
Kristen Fousek, PhD Candidate at Baylor College of Medicine, discusses her preclinical work on targeting CD19-negative relapsed B-cell acute lymphoblastic leukemia, using CAR T cells that target three antigens simultaneously, a technique that addresses the growing problem of relapse (Abstract 121).
The days leading up to our daughter Emily’s diagnosis of acute lymphoblastic leukemia (ALL) on May 28, 2010, when she was just 5, offered few clues about the terrifying, life-and-death months and years we were about to experience. She was happy and seemingly healthy, literally until the day before...
ON JANUARY 15, 2018, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly diagnosed low-risk acute promyelocytic leukemia whose disease is characterized by the presence of the...
Venetoclax (Venclexta) plus rituximab (Rituxan)—a non–chemotherapy-containing regimen—was superior to standard-of-care bendamustine plus rituximab for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to a final analysis of the phase III MURANO study reported at...
In a study reported in the Journal of Clinical Oncology, Qian et al found that loss-of-function germline TP53 variants increase the risk of childhood B-cell acute lymphoblastic leukemia (ALL), as well as the risk of poorer response to therapy and second malignancies. Study Details In the study,...
On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17)...
In a study reported in the Journal of Clinical Oncology, Molenaar et al found that radioiodine treatment for well-differentiated thyroid cancer was associated with an increased risk of acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) compared with thyroidectomy alone. Study Details ...
An interim analysis of a phase II trial reported by Jones et al in The Lancet Oncology indicates that venetoclax (Venclexta) produces a response in a high proportion of patients with chronic lymphocytic leukemia progressing on or after ibrutinib (Imbruvica) treatment. Study Details The study...
On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...
BOSUTINIB ( BOSULIF) is the latest tyrosine kinase inhibitor that has shown a superior molecular response profile when compared with imatinib.1,2 An orally available dual SRC/ABL1 inhibitor, the drug was shown in preclinical studies to have a potent inhibitory activity against BCR-ABL1 and minimal ...
Immunotherapy in PD-L1–Positive Advanced Cervical Cancer Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Jean-Sebastien Frenel, MD, of...
THE COMBINATION of ibrutinib (Imbruvica) plus venetoclax (Venclexta) achieved favorable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to initial results of the phase II CLARITY trial presented at the 2017 American Society of Hematology (ASH) Annual ...
IN THE PHASE III BFORE trial reported in the Journal of Clinical Oncology by Jorge E. Cortes, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, the SRC/ABL kinase inhibitor bosutinib (Bosulif) improved response rates vs imatinib in the first-line treatment of patients with...
On December 19, the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta). The draft report, along with draft voting...
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
John F. Seymour, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses an interim analysis of venetoclax plus rituximab vs bendamustine plus rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (Abstract LBA-2).
Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study results on combined venetoclax and ibrutinib for patients with previously untreated high-risk and relapsed/refractory chronic lymphocytic leukemia (Abstract 429).
One-third of patients with previously treated chronic lymphocytic leukemia (CLL) had no detectable disease after 6 months of combination therapy with the targeted agents ibrutinib (Imbruvica) and venetoclax (Venclexta), with no increase in the occurrence of tumor-lysis syndrome, a serious treatment ...
At the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, the 3-year follow-up data from the RESONATE-2 study (PCYC-1115/1116) were presented. The investigators found that patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)...
Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...
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. Kjeld Schmiegelow, MD, of The University Hospital...
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on pediatric leukemia. These studies highlight quality-of-life reporting; neutropenia management; combination chemotherapy; chimeric antigen receptor (CAR) T-cell therapy and some...
NYU Langone Health has announced that nationally renowned physician and researcher Raoul Tibes, MD, PhD, Associate Professor of Hematology and Medical Oncology at NYU School of Medicine, will lead efforts to expand the clinical and investigative leukemia programs at its Perlmutter Cancer Center....
On November 9, 2017, dasatinib (Sprycel) was granted regular approval for treatment of pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase.1,2 Supporting Efficacy Data Approval was based on findings among 97 pediatric patients with chronic-phase...
When choosing their preferred treatment, patients with chronic lymphocytic leukemia (CLL) place the highest value on treatments that deliver the longest progression-free survival, but they are willing to swap some drug efficacy for a reduced risk of serious adverse events, according to a study...
In a study reported in the Journal of Clinical Oncology, O’Connor et al combined genetic subtypes and minimal residual disease as a continuous variable to construct a risk stratification model for pediatric acute lymphoblastic leukemia (ALL). Study Details The study involved a...
Seattle Children’s has opened the first chimeric antigen receptor (CAR) T-cell immunotherapy trial in the U.S. for children and young adults with relapsed or refractory CD19- and CD22-positive acute lymphoblastic leukemia (ALL) that will simultaneously attack two targets on cancer cells. With ...
A RECENTLY PUBLISHED STUDY in JAMA Oncology, led by Mohamed Sorror, MD, MSc, and Elihu Estey, MD, of the Fred Hutchinson Cancer Research Center (Fred Hutch), involving five collaborating institutions, provides a novel model to predict 1-year survival rates of patients after beginning treatment...
Although a majority of major cancer centers may test for minimal residual disease (MRD), a recent survey conducted by researchers at Moffitt Cancer Center, Tampa, Florida, suggests most oncologists remain uncertain about what to do with the results. At the National Comprehensive Cancer Network®...
Although the indications to initiate treatment for chronic lymphocytic leukemia (CLL) have not changed, determining the optimal first-line treatment and sequence of therapies once treatment has begun remain challenges for providers. At the National Comprehensive Cancer Network® (NCCN®) 12th Annual...