Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 42
Summary
- Conditions
- Lymphoma
- Multiple Myeloma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This is a phase Ib-IIA study of post-transplant combined check point inhibitors for patients with a high risk of relapse (>50%) after an autologous hematopoietic stem cell transplant. Patients will accrue to study by disease groups and followed separately by group for incidence and severity of toxic...
This is a phase Ib-IIA study of post-transplant combined check point inhibitors for patients with a high risk of relapse (>50%) after an autologous hematopoietic stem cell transplant. Patients will accrue to study by disease groups and followed separately by group for incidence and severity of toxicity, ability to receive intended schedule of combined check point inhibitors and for complete response and progression free survival (PFS) rates. Complete response and progression free survival rates will be compared to published standards for each disease group. Expected PFS at 18 months for all post-transplant groups without check point inhibitors is less than 50%. Each group with PFS at 18 months in 4 or more patients (57%) will be considered for eligibility in a successor phase IIB expansion trial.
Tracking Information
- NCT #
- NCT02681302
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Michele Donato, MD Hackensack Meridian Health