Recruiting nowPhase 2Ages 12 Years and up
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
Sponsor: M.D. Anderson Cancer Center · NCT03589729 on ClinicalTrials.gov ↗
Conditions studied
Acute Myeloid LeukemiaBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBlasts 10 Percent or More of Bone Marrow Nucleated CellsHigh Risk Myelodysplastic SyndromeMyeloid SarcomaMyeloproliferative NeoplasmPhiladelphia Chromosome Positive
What it tests
- Cladribinedrug
- Cytarabinedrug
- Dexrazoxane Hydrochloridedrug
- Gemtuzumab Ozogamicindrug
- Idarubicindrug
Where it's running1 site
- Recruiting now
M D Anderson Cancer Center
Houston, Texas 77030
- Maro Ohanian(contact)713-792-2631
- Maro Ohanian(principal investigator)
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
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.
Updated 2026-05-22 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.