Dexrazoxane Hydrochloride for Heart Protection in Blood Cancers
This study is testing if a drug called dexrazoxane hydrochloride can help prevent heart-related side effects when people with certain blood cancers receive chemotherapy. The blood cancers include acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), and chronic myeloid leukemia. You would receive dexrazoxane hydrochloride along with chemotherapy drugs like cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin. Researchers will measure how many participants experience a decrease in their heart's pumping ability (left ventricular ejection fraction or LVEF) over 6 months. This study aims to enroll about 100 participants aged 12 and older. The current status of the study is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 100 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your heart's pumping ability (LVEF) will be measured at the beginning of the study and up to 6 months after treatment.
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NCT03589729
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
Recruiting
PHASE2Ages 12+InterventionalSupportive careM.D. Anderson Cancer CenterInvestigator-initiated
~100 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:CladribineCytarabineDexrazoxane HydrochlorideGemtuzumab OzogamicinIdarubicin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF)
Measured over Baseline up to 6 months
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Maro Ohanian · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF)Baseline up to 6 months
Will assess a decrease in LVEF of 10 percent from baseline or decrease in LVEF below the normal limit of 50% during treatment with dexrazoxane hydrochloride combined with cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin.