NCT03504410 : Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (≥60 Years) With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

60+Age Over 60

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia,Leukaemia

Trial Overview Read MoreRead more

This phase III trial is trying to determine if the addition of a new drug (CPI-613) to high-dose chemotherapy (CHAM) will improve the likelihood of remission in patients who are greater than 60 years old and have acute myeloid leukaemia that has gotten worse or not responded to other treatments .
 

This trial is treating patients with acute myeloid leukaemia (AML).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (≥60 Years) With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Commercial Sponsor

Rafael Pharmaceuticals, Inc.

Summary

Eligible patients will be randomised to receive 5 doses of Cytarabine (1gm/m2 every 12 hours, starting day 3) and 3 doses of Mitoxantrone (6gm/m2, everyday following the 1st, 3rd and 5th doses of Cytarabine) alone or in combination with (2000mg/m2/day) CPI-613 from day 1 to 5.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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