Recruiting
Phase 2

Dexrazoxane

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03589729

Conditions

Acute Myeloid Leukemia

Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Blasts 10 Percent or More of Bone Marrow Nucleated Cells

High Risk Myelodysplastic Syndrome

Myeloid Sarcoma

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Cladribine

Cytarabine

Dexrazoxane Hydrochloride

Gemtuzumab Ozogamicin

Idarubicin

Study Details

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.

Conditions

Acute Myeloid Leukemia

Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Blasts 10 Percent or More of Bone Marrow Nucleated Cells

High Risk Myelodysplastic Syndrome

Myeloid Sarcoma

Study ID

NCT03589729

Start date

Sep 19, 2018

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (dexrazoxane hydrochloride, chemotherapy)

See detailed description.

Interventions

Cladribine

Given IV

Cytarabine

Given IV

Dexrazoxane Hydrochloride

Given IV

Gemtuzumab Ozogamicin

Given IV

Idarubicin

Given IV

Primary outcome measure

  • Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF) [ Time Frame: Baseline up to 6 months ]

Central Contacts and Locations

Central contacts

Maro Ohanian

713-792-2631mohanian@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Maro Ohanian

713-792-2631

Principal Investigator:

Maro Ohanian

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-22.