Ziftomenib + Venetoclax + Gemtuzumab for Acute Myeloid Leukemia

Overseen By Branko Cuglievan, MD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy, Antileukemic agents

Disqualifiers: Chronic liver disease, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

Trial Summary

What is the purpose of this trial?

To find the recommended dose of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax that can be given to pediatric participants who have relapsed or refractory AML or MPAL.

Research Team

Branko Cuglievan

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for pediatric patients with relapsed or refractory Acute Myeloid Leukemia (AML) or Mixed Phenotype Acute Leukemia (MPAL). Specific eligibility criteria details are not provided.

Inclusion Criteria

My kidneys work well enough (creatinine clearance ≥ 30 mL/min).

I am currently receiving treatment for brain disease prevention or control.

Baseline ejection fraction must be > 40%

Exclusion Criteria

I weigh less than 10kg.

I do not have severe active GVHD or chronic GVHD.

Mean corrected QT interval by Fredericia's formula >480 ms on triplicate 12-lead electrocardiograms performed within approximately 5 minutes of each other

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax to determine the recommended Phase II dose

12-16 weeks

Dose Expansion

Participants receive the recommended Phase II dose of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax to further assess safety and efficacy

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Gemtuzumab
• Venetoclax
• Ziftomenib

Trial Overview The study aims to determine the appropriate dose of Ziftomenib when combined with Venetoclax and Gemtuzumab in children who have AML that has returned after treatment or hasn't responded to previous treatments.

Participant Groups

Group I: Dose Escalation + Dose Expansion Experimental Treatment 3 Interventions

Participants found to be eligible to take part in this study, you will be assigned to a dose level of ziftomenib based on when you join this study. Up to 4 dose levels of ziftomenib will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the recommended dose of ziftomenib is found.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Kura Oncology, Inc.

Industry Sponsor

Trials

19

Recruited

1,700+