Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers

NCT03589729 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: 2017-0937NCI-2018-01108P30CA016672
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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; Myeloproliferative Neoplasm; Philadelphia Chromosome Positive

Outcome Measures

Primary Outcomes (1)

• Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF)

  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.

  Baseline up to 6 months

Secondary Outcomes (9)

• Incidence of cardiac symptoms

  Up to 1 year

• Assessment of change in troponin I and high-sensitivity troponin T

  Up to 1 year

• Incidence of adverse events

  Up to 1 year

• Complete remission (CR) /complete remission with incomplete blood count recovery (CRi) rates (Cohorts 1-3)

  Up to 1 year

• Overall response (Cohorts 1-3)

  Up to 1 year

Other Outcomes (2)

• Assessment of metal chelation effects of dexrazoxane and chemotherapy

  Up to 1 year

• Assessment of minimal residual disease (MRD)

  Up to 1 year

Study Arms (1)

Supportive care (dexrazoxane hydrochloride, chemotherapy)

EXPERIMENTAL

See detailed description.

Drug: Cladribine; Drug: Cytarabine; Drug: Dexrazoxane Hydrochloride; Drug: Gemtuzumab Ozogamicin; Drug: Idarubicin

Interventions

Cladribine DRUG

Given IV

Also known as: 2-CdA, 2CDA, CdA, Cladribina, Leustat, Leustatin, Leustatine, RWJ-26251

Supportive care (dexrazoxane hydrochloride, chemotherapy)

Cytarabine DRUG

Given IV

Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453

Supportive care (dexrazoxane hydrochloride, chemotherapy)

Dexrazoxane Hydrochloride DRUG

Given IV

Also known as: Cardioxane, Totect, Zinecard

Supportive care (dexrazoxane hydrochloride, chemotherapy)

Gemtuzumab Ozogamicin DRUG

Given IV

Also known as: Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody, CDP-771, CMA-676, gemtuzumab, hP67.6-Calicheamicin, Mylotarg, WAY-CMA-676

Supportive care (dexrazoxane hydrochloride, chemotherapy)

Idarubicin DRUG

Given IV

Also known as: 4-Demethoxydaunomycin, 4-demethoxydaunorubicin, 4-DMDR

Supportive care (dexrazoxane hydrochloride, chemotherapy)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Blast Crisis; Sarcoma, Myeloid; Myeloproliferative Disorders

Interventions

Cladribine; Cytarabine; Dexrazoxane; Razoxane; Gemtuzumab; Idarubicin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sarcoma; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Diketopiperazines; Piperazines; Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Maro Ohanian

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maro Ohanian

CONTACT

713-792-2631; mohanian@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 18, 2018
• Study Start: September 19, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

US (1)