Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 12 and up

Using dexrazoxane to protect the heart during chemotherapy for blood cancers

Official title: Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms

Run by M.D. Anderson Cancer Center · NCT03589729 · Data updated 2026-11-12

This study is testing if a drug called dexrazoxane can help protect the hearts of people with blood cancers from damage caused by chemotherapy.

More Acute Myeloid Leukemia trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages12 Years and up
SexAll
Enrollment100 (estimated)
SponsorM.D. Anderson Cancer Center
Academic / other
Drugs / interventionschemotherapy, gemtuzumab
Locations1 site (Houston, Texas)
StatusRecruiting
StartedSeptember 19, 2018
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedNovember 10, 2026
Trial IDNCT03589729 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients diagnosed with acute myeloid leukemia, high-risk myelodysplastic syndrome, or chronic myeloid leukemia in blast phase with a baseline left ventricular ejection fraction of 50% or higher.

Probably not a fit

Patients with pre-existing heart conditions or those with a baseline left ventricular ejection fraction below 50% may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of dexrazoxane hydrochloride in preventing heart-related side effects caused by chemotherapy in patients with blood cancers such as acute myeloid leukemia and high-risk myelodysplastic syndrome. The study aims to measure the percentage of patients experiencing a significant decrease in heart function during treatment with chemotherapy drugs like cladribine and idarubicin. Secondary objectives include monitoring cardiac symptoms and assessing the safety profile of dexrazoxane. The trial also explores the potential benefits of metal chelation effects from dexrazoxane in conjunction with chemotherapy.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of heart damage in patients undergoing chemotherapy for blood cancers.

How similar studies have gone: Other studies have shown promise in using chemoprotective agents like dexrazoxane, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography (echo) or multigated acquisition (MUGA) scan.
* Patients of child bearing potential should use contraception.
* Patients with a diagnosis of acute myeloid leukemia (AML), or high risk myelodysplastic syndrome (MDS) (\>= 10% blasts or International Prognostic Scoring System \[IPSS\] \>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible.
* Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible.
* Patients with myeloproliferative neoplasms in blast phase will be eligible.
* Patients with isolated extramedullary myeloid neoplasm will be eligible.
* Patients with active CNS (central nervous system) disease are eligible.
* Bilirubin \< 2mg/dL.
* AST (aspartate aminotransferase) and/or ALT (alanine aminotransferase) \< 3 x ULN (upper limit of normal) - or \< 5 x ULN if related to leukemic involvement.
* Creatinine \< 1.5 x ULN.
* Hyperbilirubinemia is allowed if due to Gilbert's hyperbilirubinemia.
* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
* Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
* Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses of cytarabine, various combination-chemotherapy regimens, hematopoietic growth factors, azacytidine, decitabine, ATRA (all-trans retinoic acid).
* Cohort 1: Frontline cohort patients are eligible in the frontline cohort if they are untreated or previously treated already in CR if they received 3 or fewer cycles of previous chemotherapy (including either 1 induction and 2 consolidations or 2 inductions and 1 consolidation).
* Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvage cohort 2 if they have active disease after first or second relapse or if they are in CR after previously documented first or second relapse as long as they if they have received 3 or fewer cycles of chemotherapy to achieve the most current CR.
* Cohort 3: Salvage cohort in 3rd salvage and beyond patients may be eligible in salvage cohort 3 if they have active disease after 3rd or greater relapse or if they are in CR after a previously documented relapse (3rd or greater), but may have only received 3 or fewer cycles of chemotherapy to achieve the most current CR.
* Cohort 4: Maintenance cohort: Patients in CR who are considered by treating physician to benefit from maintenance therapy are eligible for maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine.

Exclusion Criteria:

* Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk.
* Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months.
* Decompensated heart failure (HF).
* Clinically significant arrhythmias.
* Severe valvular disease.
* History of coronary artery disease (CAD).
* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
* Psychiatric illness/social situations that would limit compliance with study requirements per the judgment of the investigator.
* Patient with documented hypersensitivity to any of the components of the chemotherapy program.
* Men and women of childbearing potential who do not practice contraception.

Where it's running

  • M D Anderson Cancer Center
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.