Bisantrene for Relapsed /Refractory AML
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03820908|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia Allogeneic Stem Cell Transplantation||Drug: Bisantrene||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 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|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
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||Recruiting|
|Ramat Gan, Israel, 57261|
|Contact: Arnon Nagler, M.D. 972-3-530 5830 Arnon.Nagler@sheba.health.gov.il|