← All sarcoma trials
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

  • M D Anderson Cancer Center

    Houston, Texas 77030

    Recruiting now
    • 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.