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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03589729
Phase
PHASE2
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cladribine — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Dexrazoxane Hydrochloride — DRUG
    Given IV
  • Gemtuzumab Ozogamicin — DRUG
    Given IV
  • Idarubicin — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Sep 19, 2018
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (dexrazoxane hydrochloride, chemotherapy)
    See detailed description.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Maro Ohanian
713-792-2631
Maro Ohanian (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
M D Anderson Cancer Center· Houston, TX

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