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Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms

NCT04797767 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-17

No results posted yet for this study

Summary

This phase I/II trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine, and mitoxantrone, 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 with CLAG-M may kill more cancer cells.

Conditions

  • Acute Biphenotypic Leukemia
  • Acute Myeloid Leukemia
  • Mixed Phenotype Acute Leukemia
  • Myeloid Neoplasm
  • Relapsed Acute Biphenotypic Leukemia
  • Relapsed Acute Myeloid Leukemia
  • Relapsed Mixed Phenotype Acute Leukemia
  • Relapsed Myeloid Neoplasm
  • Refractory Acute Biphenotypic Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory Mixed Phenotype Acute Leukemia
  • Refractory Myeloid Neoplasm
  • Recurrent Myeloid Sarcoma

Interventions

DRUG

Cladribine

Given IV

DRUG

Cytarabine

Given IV

DRUG

Mitoxantrone

Given IV

BIOLOGICAL

Recombinant Granulocyte Colony-Stimulating Factor

Given subcutaneously

DRUG

Venetoclax

Given PO

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

Principal Investigators

  • Mary-Beth M. Percival · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04797767 on ClinicalTrials.gov