Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers
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|ClinicalTrials.gov Identifier: NCT03589729|
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : November 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Cladribine Drug: Cytarabine Drug: Dexrazoxane Hydrochloride Drug: Gemtuzumab Ozogamicin Drug: Idarubicin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms|
|Actual Study Start Date :||September 19, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Supportive care (dexrazoxane hydrochloride, chemotherapy)
See detailed description.
Drug: Dexrazoxane Hydrochloride
Drug: Gemtuzumab Ozogamicin
- Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF) [ Time Frame: Baseline up to 6 months ]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.
- Incidence of cardiac symptoms [ Time Frame: Up to 1 year ]Cardiac symptoms to be evaluated include: clinical heart failure, exertional dyspnea, orthopnea, S3 gallop, acute coronary syndrome, acute pulmonary edema and life-threatening arrhythmias
- Assessment of change in troponin I and high-sensitivity troponin T [ Time Frame: Up to 1 year ]Troponin levels will be collected before and after the day 1 dose of idarubicin each month during induction, consolidation, and maintenance therapy.
- Incidence of adverse events [ Time Frame: Up to 1 year ]
- Complete remission (CR) /complete remission with incomplete blood count recovery (CRi) rates (Cohorts 1-3) [ Time Frame: Up to 1 year ]
- Overall response (Cohorts 1-3) [ Time Frame: Up to 1 year ]
- Overall survival (Cohorts 1-3) [ Time Frame: Up to 1 year ]
- Event-free survival (Cohorts 1-3) [ Time Frame: Up to 1 year ]
- Remission duration (Cohorts 1-3) [ Time Frame: Up to 1 year ]
- Recurrence-free survival [ Time Frame: Up to 6 months ]The recurrence-free survival rate at 6 months will be a binary endpoint where the recurrence including death occurred within 6 months of treatment will be considered as "recurrence event".
- Assessment of metal chelation effects of dexrazoxane and chemotherapy [ Time Frame: Up to 1 year ]Metal chelation effects assessed by utilizing technologies commonly used in the geochemistry.
- Assessment of minimal residual disease (MRD) [ Time Frame: Up to 1 year ]Will explore the impact of MRD on relapse.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589729
|Contact: Maro Ohanianfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maro Ohanian 713-792-2631|
|Principal Investigator: Maro Ohanian|
|Principal Investigator:||Maro Ohanian||M.D. Anderson Cancer Center|