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Mitochondrial Metabolism Inhibitor

CPI-613 + HD Cytarabine and Mitoxantrone for Acute Myeloid Leukemia

Phase 3
Waitlist Available
Led By Jorge Eduardo Cortes, MD
Research Sponsored by Rafael Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial is testing whether adding CPI-613 to standard chemotherapy can improve outcomes in older patients with relapsed or refractory acute myeloid leukemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months 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 Remission (CR)
Secondary outcome measures
CR+CRh
Overall Survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CPI-613 + HD Cytarabine and MitoxantroneExperimental Treatment1 Intervention
CPI-613 + High Dose Cytarabine and Mitoxantrone CPI-613 at 2,000 mg/m2/day from day 1 to 5. Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 2nd and 5th doses of Cytarabine.
Group II: Control (HAM) and control sub-groups (MEC and FLAG)Active Control3 Interventions
High Dose Cytarabine and Mitoxantrone Cytarabine at 1gm/m2 (5 doses), every 12 hours starting day 3. Mitoxantrone at 6gm/m2 (3 doses), everyday following the 1st, 3rd and 5th doses of Cytarabine. Mitoxantrone, Etoposide and Cytarabine Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6 Fludarabine, Cytarabine and Filgrastim Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5

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Who is running the clinical trial?

Rafael Pharmaceuticals Inc.Lead Sponsor
8 Previous Clinical Trials
596 Total Patients Enrolled
Cornerstone PharmaceuticalsLead Sponsor
14 Previous Clinical Trials
661 Total Patients Enrolled
Jorge Eduardo Cortes, MDPrincipal InvestigatorAugusta University
~29 spots leftby Sep 2025
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