Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS
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|ClinicalTrials.gov Identifier: NCT04749355|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2021
Last Update Posted : February 15, 2021
An open label multi center study to assess the safety and efficacy of BST-236 as single agent in adult patients unfit for standard therapy with Acute Myeloid Leukemia (AML) or higher-risk (HR) Myelodysplastic Syndromes (MDS) who fail to respond or relapsed following first line therapy.
Approximately 20 adult patients with relapsed and/or refractory AML and approximately 20 adult patients with relapsed and/or refractory HR MDS, will be enrolled into the study.
Patients will be treated with 1-2 induction courses and 2-4 maintenance courses. All patients will be followed for 1 year in the study and additional 1 year post study follow-up.
|Condition or disease||Intervention/treatment||Phase|
|AML, Adult MDS Relapse/Recurrence Refractory Acute Myeloid Leukemia||Drug: BST-236||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, multi-center, single arm, single agent study|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy With Relapsed or Refractory AML or Higher-Risk Myelodysplastic Syndromes|
|Estimated Study Start Date :||March 14, 2021|
|Estimated Primary Completion Date :||August 14, 2022|
|Estimated Study Completion Date :||March 14, 2024|
BST-236 Intravenous, 4.5 g/m^2/d or 2.3 g/m^2/d, for 6 days
BST-236 is a conjugate of cytarabine and asparagine, provided as a sterile lyophilized powder for IV administration
Other Name: Aspacytarabine
- CR rate [ Time Frame: To be assessed 5 months after the last patient was enrolled to the study ]In AML patients -The proportion of patients who achieve a CR per the IWG 2006 Criteria
- Overall response rate (ORR) [ Time Frame: To be assessed 5 months after the last patient was enrolled to the study ]In MDS patients -Overall response rate (ORR), defined as the proportion of patients who achieve a CR or PR per proposal for modification of the International Working Group (IWG) criteria for MDS, 2006
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): NCT04749355
|Contact: Liat Flaishon||+97236568669||Liat@Biosight-pharma.com|