Evidence map›Paper›PMID 39415930›Full record

ArticleEJHaem2024

A phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B-cell or T-cell acute lymphoblastic leukemia: Results from the ECOG-ACRIN EA9152 protocol.

Neil D Palmisiano, Ju-Whei Lee, David F Claxton, Elisabeth M Paietta, Hassan Alkhateeb, Jae Park, Nikolai A Podoltsev, Ehab L Atallah, Dale G Schaar, Shira N Dinner and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in EJHaem, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03504644 (A Phase IB/II Study of Venetoclax), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03504644 phase1 / phase2active not recruitingnot on this map

A Phase IB/II Study of Venetoclax (ABT-199) in Combination With Liposomal Vincristine or Vincristine Sulfate in Patients With Relapsed or Refractory T-Cell or B-Cell Acute Lymphoblastic Leukemia

TypeinterventionalSponsorECOG-ACRIN Cancer Research GroupRan2018 to 2028Enrolled40ConditionsRecurrent Adult Lymphoblastic Lymphoma, Recurrent B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma, Recurrent T Acute Lymphoblastic LeukemiaArmsBiospecimen Collection, Computed Tomography, Lumbar Puncture, Positron Emission Tomography, Venetoclax
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Article
  2. Observational
  3. Review
  4. Article
  5. Article
  6. Mitochondria and Acute Leukemia: A Clinician's Perspective.International journal of molecular sciences · 2024
    Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Neil D PalmisianoRutgers-Cancer Institute of New Jersey New Brunswick New Jersey USA.ORCID https://orcid.org/0000-0003-1524-8108
Ju-Whei LeeDana-Farber Cancer Institute - ECOG-ACRIN Biostatistics Center Boston Massachusetts USA.
David F ClaxtonPenn State Cancer Institute Penn State Milton S. Hershey Medical Center Hershey Pennsylvania USA.ORCID https://orcid.org/0000-0001-9209-2405
Elisabeth M PaiettaDepartment of Oncology Montefiore Medical Center Moses Campus Bronx New York USA.
Hassan AlkhateebDivision of Hematology Mayo Clinic Rochester New York USA.ORCID https://orcid.org/0000-0002-3609-8404
Jae ParkLeukemia Service Memorial Sloan Kettering Cancer Center New York New York USA.
Nikolai A PodoltsevSection of Hematology Yale University School of Medicine New Haven Connecticut USA.ORCID https://orcid.org/0000-0002-3657-778X
Ehab L AtallahDivision of Hematology and Oncology Medical College of Wisconsin Milwaukee Wisconsin USA.ORCID https://orcid.org/0000-0002-9919-3564
Dale G SchaarRutgers-Cancer Institute of New Jersey New Brunswick New Jersey USA.
Shira N DinnerHematology Oncology Division Northwestern University Feinberg School of Medicine Chicago Illinois USA.
Jonathan A WebsterSidney Kimmel Cancer Center Johns Hopkins University Baltimore Maryland USA.ORCID https://orcid.org/0000-0003-3647-6345
Selina M LugerAbramson Cancer Center University of Pennsylvania Philadelphia Pennsylvania USA.ORCID https://orcid.org/0000-0003-3364-4366
Mark R LitzowDivision of Hematology Mayo Clinic Rochester New York USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
Yale Cancer Center NCTN LAPSUG1CA233337 · NCI · YALE UNIVERSITY · PI ANNE C CHIANG · 2019 to 2026
$6.0M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA189859NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233196NCI NIH HHS UG1 CA233198NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233337NCI NIH HHS UG1 CA233341
6 · The paper itself

Abstract

Introduction: Relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) remains a therapeutic challenge. Preclinical data in both B- and T-ALL suggests synergy of venetoclax (VEN) with vincristine (VCR). We designed a phase I/II trial (EA9152) of the combination of L-VCR and VEN for patients with r/r B-or T-cell ALL or LL. Here, we report the safety and efficacy outcomes of the phase I portion of this trial (NCT03504644). Methods: In a 3+3 dose escalation design, r/r ALL subjects were given single-agent VEN doses reaching 400, 600, or 800 mg for the three respective dose levels. Weekly L-VCR at 2.25 mg/m Results: Among the 18 patients in phase I, grade ≥ 3 treatment-related adverse events were reported in 89% of treated patients. Two patients (two of three) at dose level 3 experienced dose-limiting toxicities. Therefore, the MTD of the combination was determined to be dose level 2 (VEN 600 mg). Twenty-two percent of evaluable patients ( Conclusion: The combination of VEN and L-VCR was found to be safe for patients with r/r ALL and encouraging preliminary efficacy, including MRD negative responses. With the removal of L-VCR from the US market, the phase 2 portion of this trial is actively enrolling with vincristine sulfate.

Indexed as

acute leukaemiaBCL‐2clinical trials

Identifiers

PMID39415930
PMCPMC11474352

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.