Recruitment

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