Bisantrene for Relapsed /Refractory AML
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|ClinicalTrials.gov Identifier: NCT03820908|
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Allogeneic Stem Cell Transplantation||Drug: Bisantrene||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The patientswith Rel /Ref AML will receive bisantrene in conjunction with the conventional supportive care. In the event of a CR, patients will receive a 3-day consolidation course of bisantrene 250mg/m2/d (optional).|
|Masking:||None (Open Label)|
|Official Title:||Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)|
|Actual Study Start Date :||July 18, 2019|
|Actual Primary Completion Date :||May 19, 2020|
|Actual Study Completion Date :||July 22, 2020|
patients will receive bisantrene 250mg/m2/d for 7 days
The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.
- Overall survival [ Time Frame: 24 months ]Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
- Leukemia-free survival [ Time Frame: 24 months ]Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.
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): NCT03820908
|Chaim Sheba Medical Center|
|Ramat Gan, Israel, 57261|