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Safety and Efficacy of Venetoclax, Cytarabine and Metformin (VenCM) for Relapsed-Refractory and Induction-Ineligible Acute Myeloid Leukemia

NCT06537843 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-05

No results posted yet for this study

Summary

Phase 2 clinical trial to evaluate the combination of venetoclax, cytarabine and metformin in relapsed-refractory and induction ineligible acute myeloid leukemia.

Conditions

Interventions

DRUG

Venetoclax

Venetoclax, PO (tablet), 200 - 400mg, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).

DRUG

Cytarabine Injection

Cytarabine, Subcutaneous injection, 10 - 100mg per square meter, once-daily, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).

DRUG

Metformin

Metformin, PO (tablet), 850mg, three times a day, 10 days per cycle (cycle 1), 5 days per cycle (cycle 2 and subsequent cycles).

Sponsors & Collaborators

  • Hospital de Clínicas da UFPR. Curitiba, PR, Brazil

    collaborator UNKNOWN

  • Hospital Ophir Loyola. Belem, PA, Brazil

    collaborator UNKNOWN

  • Hospital Universitario Polydoro Ernani de São Thiago. Florianopolis, SC, Brazil

    collaborator UNKNOWN

  • Hospital Amaral Carvalho. Jau, SP, Brazil

    collaborator UNKNOWN

  • Hospital Municipal São José

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-07-01
Completion
2028-07-01

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT06537843 on ClinicalTrials.gov