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Antimetabolite

Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement

Phase 1 & 2

Waitlist Available

Led By James S Blachly

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of combining pinometostat with standard chemotherapy in patients newly diagnosed with a specific type of acute myeloid leukemia. Pinometostat blocks enzymes needed for cancer cell growth, while the chemotherapy drugs kill or stop the cancer cells from spreading. The goal is to find the best dose and see if this combination works better than standard treatment alone.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response (CR) or Complete Response With Incomplete Count Recovery (CRi) Rate

Dose Limiting Toxicity (Phase Ib)

Secondary study objectives

Differential Blast Counts

Number of Participants With Incidence of Adverse Events

Overall Survival

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort II (higher dose pinometostat)Experimental Treatment4 Interventions

Patients receive higher dose pinometostat intravenously (IV) continuously on days 1-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.

Group II: Cohort I (higher and lowers dose pinometostat)Experimental Treatment4 Interventions

Patients receive higher dose pinometostat IV continuously on days 1-7 and lower dose pinometostrat IV continuously on days 8-35. Patients also receive daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients who do not achieve CR/CRi after treatment receive pinometostat IV continuously on days 1-28, daunorubicin hydrochloride IV over 10-30 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pinometostat

2020

Completed Phase 2

~10

Cytarabine

2016

Completed Phase 3

~4020