TerminatedPhase 1/2

Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia

Stopped: 75% \> Participants

United States110 participantsStarted 2020-07-28

Plain-language summary

This phase Ib/II trial studies the side effects and best dose of magrolimab and venetoclax when given together with azacitidine and to see how well they work in treating patients with acute myeloid leukemia. Magrolimab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as azacitidine, 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. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving magrolimab, azacitidine, and venetoclax may help to control the disease.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Left ventricular ejection fraction (LVEF) ≤50%.
✓. Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
✓. Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
✓. Chronic stable angina or congestive heart failure controlled with medication.
✓. Creatinine clearance ≥ 30 mL/min to \< 45 ml/min calculated by the Cockcroft-Gault formula or measured by 24 hours' urine collection
✓. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception
✓. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
✓. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository In case of use of oral contraception, women should have been stable on the same pill before taking study treatment.

What they're measuring

Maximum Tolerated Dose of the Combination Drugs (Phase Ib)

Timeframe: Up to 12 cycles

Participants With a Response (Complete Remission + Complete Remission With Incomplete Count Recovery)

Timeframe: Within 3 months of treatment initiation

Event-free Survival

Timeframe: Up to 4 years, 7 months and 15 days.

Overall Survival

Timeframe: Up to 4 years, 7 months and 15 days.

Trial details

NCT IDNCT04435691

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-25

Results submitted2025-12-19

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Left ventricular ejection fraction (LVEF) ≤50%.
✓. Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
✓. Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
✓. Chronic stable angina or congestive heart failure controlled with medication.
✓. Creatinine clearance ≥ 30 mL/min to \< 45 ml/min calculated by the Cockcroft-Gault formula or measured by 24 hours' urine collection
✓. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception
✓. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
✓. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository In case of use of oral contraception, women should have been stable on the same pill before taking study treatment.

What they're measuring

Maximum Tolerated Dose of the Combination Drugs (Phase Ib)

Timeframe: Up to 12 cycles

Participants With a Response (Complete Remission + Complete Remission With Incomplete Count Recovery)

Timeframe: Within 3 months of treatment initiation

Event-free Survival

Timeframe: Up to 4 years, 7 months and 15 days.

Overall Survival

Timeframe: Up to 4 years, 7 months and 15 days.