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Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

NCT03504644 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-13

Study results available
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Summary

This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with vincristine in treating patients with T-cell or B-cell acute lymphoblastic leukemia that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as vincristine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with vincristine may work better in treating patients with acute lymphoblastic leukemia compared to vincristine alone.

Conditions

  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent B Acute Lymphoblastic Leukemia
  • Recurrent B Lymphoblastic Lymphoma
  • Recurrent T Acute Lymphoblastic Leukemia
  • Recurrent T Lymphoblastic Lymphoma
  • Refractory B Acute Lymphoblastic Leukemia
  • Refractory B Lymphoblastic Lymphoma
  • Refractory T Acute Lymphoblastic Leukemia
  • Refractory T Lymphoblastic Lymphoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Lumbar Puncture

Undergo lumbar puncture

PROCEDURE

Positron Emission Tomography

Undergo PET scan

DRUG

Venetoclax

Given PO

DRUG

Vincristine Liposomal

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • ECOG-ACRIN Cancer Research Group

    lead NETWORK

Principal Investigators

  • Neil D Palmisiano · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2025-07-22
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504644 on ClinicalTrials.gov