Actively Recruiting
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
Led by M.D. Anderson Cancer Center · Updated on 2025-11-20
100
Participants Needed
1
Research Sites
484 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.
CONDITIONS
Official Title
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography or multigated acquisition scan.
- Patients with acute myeloid leukemia, high-risk myelodysplastic syndrome (≥ 10% blasts or IPSS ≥ intermediate-2), or high-risk myeloproliferative neoplasm.
- Patients with untreated or previously untreated chronic myeloid leukemia in myeloid blast phase or Philadelphia chromosome-positive acute myeloid leukemia.
- Patients with myeloproliferative neoplasms in blast phase.
- Patients with isolated extramedullary myeloid neoplasm.
- Patients with active central nervous system disease.
- Bilirubin less than 2 mg/dL.
- AST and/or ALT less than 3 times upper limit of normal, or less than 5 times if related to leukemic involvement.
- Creatinine less than 1.5 times upper limit of normal.
- Hyperbilirubinemia allowed if due to Gilbert's hyperbilirubinemia.
- Negative urine pregnancy test within 1 week for women of childbearing potential.
- Women of childbearing potential and men must agree to use contraception during study participation.
- Ability to understand study requirements and provide signed informed consent.
- Prior therapy allowed including hydroxyurea, rescue cytarabine, combination chemotherapy, growth factors, azacytidine, decitabine, all-trans retinoic acid.
- Frontline cohort patients untreated or previously treated with 3 or fewer chemotherapy cycles.
- Salvage cohort 1st and 2nd relapse patients with active disease or in remission after relapse with 3 or fewer chemotherapy cycles.
- Salvage cohort 3rd relapse and beyond patients with active disease or in remission after relapse with 3 or fewer chemotherapy cycles.
- Maintenance cohort patients in remission who may benefit from maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine.
You will not qualify if you...
- Any condition or laboratory abnormality placing the patient at unacceptable risk.
- Active heart disease including unstable coronary syndromes, unstable or severe angina, recent myocardial infarction within 6 months.
- Decompensated heart failure.
- Clinically significant arrhythmias.
- Severe valvular disease.
- History of coronary artery disease.
- Pregnant or breastfeeding women.
- Psychiatric illness or social situations limiting compliance.
- Documented hypersensitivity to any chemotherapy components.
- Men or women of childbearing potential not practicing contraception.
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Maro Ohanian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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