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

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2028

Conditions
Acute Myeloid Leukemia
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).

Trial Locations (5)

Unknown

NOT_YET_RECRUITING

Hospital Ophir Loyola, Belém

NOT_YET_RECRUITING

Hospital de Clínicas da UFPR, Curitiba

NOT_YET_RECRUITING

Hospital Universitario Polydoro Ernani de Sao Thiago, Florianópolis

RECRUITING

Hospital Amaral Carvalho, Jaú

RECRUITING

Hospital Municipal Sao Jose, Joinville

All Listed Sponsors
collaborator

Hospital de Clínicas da UFPR. Curitiba, PR, Brazil

UNKNOWN

collaborator

Hospital Ophir Loyola. Belem, PA, Brazil

UNKNOWN

collaborator

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

UNKNOWN

collaborator

Hospital Amaral Carvalho. Jau, SP, Brazil

UNKNOWN

lead

Hospital Municipal São José

OTHER