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Antimetabolite

Pinometostat for Acute Myeloid Leukemia

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 5 years
Awards & highlights

Study Summary

This trial is testing pinometostat, a new drug, to see if it can help treat acute myeloid leukemia, especially a type that has a certain genetic mutation. Pinometostat blocks some of the enzymes that cancer cells need to grow. The trial will also compare how well pinometostat works when given with standard chemotherapy drugs, to see if it works better than chemotherapy alone.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) or complete response with incomplete count recovery (CRi) rate
Dose limiting toxicity (Phase Ib)
Secondary outcome measures
Differential blast counts
Incidence of adverse events
Overall survival
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pinometostat)Experimental Treatment4 Interventions
Patients receive pinometostat IV continuously on days 1-35, daunorubicin hydrochloride IV over 10-30 minutes on days 8-10 and cytarabine IV continuously on days 8-14 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
~3310
Daunorubicin
2013
Completed Phase 4
~4940
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,926,161 Total Patients Enrolled
James S BlachlyPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement
2019. "Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03724084.
~1 spots leftby Apr 2025
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