Heart shield: new trial aims to prevent chemo side effects in blood cancer patients
NCT ID NCT03589729
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called dexrazoxane can protect the heart from damage caused by chemotherapy in people with certain blood cancers, such as acute myeloid leukemia and high-risk myelodysplastic syndrome. About 100 participants will receive dexrazoxane alongside standard chemo drugs. The goal is to see if it reduces heart-related side effects without affecting cancer treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2018
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Can a CDK8/CDK19 blocker help when leukemia and MDS return?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication