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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|