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Recruiting Phase 2 NCT03589729

Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers

Trial Parameters

Condition Acute Myeloid Leukemia
Sponsor M.D. Anderson Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex ALL
Min Age 12 Years
Max Age N/A
Start Date 2018-09-19
Completion 2027-12-31
Interventions
CladribineCytarabineDexrazoxane Hydrochloride

Brief Summary

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.

Eligibility 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 li

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