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Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia

NCT03808610 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-05-13

No results posted yet for this study

Summary

This phase I/II trial studies the side effects and best dose of venetoclax and how well it works in combination with low-intensity chemotherapy in patients with B- or T-cell acute lymphoblastic leukemia that has not responded to treatment or that has come back. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, including vincristine, cyclophosphamide, dexamethasone, rituximab, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with low-intensity chemotherapy may work better in treating patient with B- or T-cell acute lymphoblastic leukemia.

Conditions

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

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IV

DRUG

Dexamethasone

Given IV or PO

DRUG

Methotrexate

Given IV

DRUG

Nelarabine

Given IV

DRUG

Pegaspargase

Given IV

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Venetoclax

Given PO

DRUG

Vincristine

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Elias Jabbour · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2026-05-05
Completion
2026-05-05
FDA Drug
Yes

Countries

  • United States

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 NCT03808610 on ClinicalTrials.gov