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

ConditionsAcute 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
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cladribine

    Drug

    Given IV

  • Cytarabine

    Drug

    Given IV

  • Dexrazoxane Hydrochloride

    Drug

    Given IV

  • Gemtuzumab Ozogamicin

    Drug

    Given IV

  • Idarubicin

    Drug

    Given IV

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Supportive care (dexrazoxane hydrochloride, chemotherapy)Experimental treatment 5 interventions

Trial outcomes

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.

Time frame
Baseline up to 6 months

Secondary outcomes

1

Incidence of cardiac symptoms

Cardiac symptoms to be evaluated include: clinical heart failure, exertional dyspnea, orthopnea, S3 gallop, acute coronary syndrome, acute pulmonary edema and life-threatening arrhythmias

Time frame
Up to 1 year
2

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

Troponin levels will be collected before and after the day 1 dose of idarubicin each month during induction, consolidation, and maintenance therapy.

Time frame
Up to 1 year
3

Incidence of adverse events

Time frame
Up to 1 year
4

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

Time frame
Up to 1 year

Other outcomes

1

Assessment of metal chelation effects of dexrazoxane and chemotherapy

Metal chelation effects assessed by utilizing technologies commonly used in the geochemistry.

Time frame
Up to 1 year
2

Assessment of minimal residual disease (MRD)

Will explore the impact of MRD on relapse.

Time frame
Up to 1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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