Sabatolimab as a Treatment for Patients With Acute Myeloid Leukemia and Presence of Measurable Residual Disease After Allogeneic Stem Cell Transplantation.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 99 years
- Gender
- Both males and females
Description
This is a phase Ib/II, open label, multi-center study of sabatolimab as monotherapy and in combination with azacitidine, in participants with AML/secondary AML who have received one aHSCT and achieved complete remission but MRD+, by local assessment, anytime between day 100 and day 365 post-aHSCT an...
This is a phase Ib/II, open label, multi-center study of sabatolimab as monotherapy and in combination with azacitidine, in participants with AML/secondary AML who have received one aHSCT and achieved complete remission but MRD+, by local assessment, anytime between day 100 and day 365 post-aHSCT and at least 2 weeks after immunosuppressive medications have been tapered off. The study will enroll approximately 59 participants and will be conducted in two parts: Part 1 is a Safety Run-in of approximately 20 participants, to assess whether sabatolimab as monotherapy at the two tested dose levels (400 mg and 800 mg intravenously Q4W) is safe when administered in the post-aHSCT setting. For each dose level, once the required number of evaluable participants has been confirmed, enrollment will be halted until participants have completed the DLT observation period (? 8 weeks following the first dose). Following the observation period for DLTs, a Safety Review Meeting will be conducted after each dose level to assess safety and determine the recommended dose for expansion to proceed with enrollment of additional cohorts in Part 2 of the study. Part 2 consists of sabatolimab monotherapy expansion cohort of approximately 13 participants, sabatolimab in combination with azacitidine cohort of approximately 20 participants, and an adolescent cohort of approximately 6 participants (? 12 years but < 18 years of age) with sabatolimab as monotherapy. Sabatolimab will be administered at the recommended dose for expansion determined in Part 1.
Tracking Information
- NCT #
- NCT04623216
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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