Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myeloid/Lymphoblastic Leukemia
  • Allogeneic Stem Cell Transplant Candidate
  • Lymphoproliferative Disorders
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a Phase I, pilot study designed to treat 10 participants with the donor NK/?? T cell-enriched product on transplant Day 28.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 125 years
Gender
Both males and females

Description

The primary objective of this study is to investigate if donor lymphocytes depleted of TCR-?? T cells and B cells can be infused on Day 28 following allogeneic stem cell transplantation without inducing Grade III-IV graft versus host disease, Grade II GVHD requiring systemic treatment and or new ons...

The primary objective of this study is to investigate if donor lymphocytes depleted of TCR-?? T cells and B cells can be infused on Day 28 following allogeneic stem cell transplantation without inducing Grade III-IV graft versus host disease, Grade II GVHD requiring systemic treatment and or new onset, severe neutropenia requiring growth factor support. This study also seeks to characterize the lymphocyte subsets obtained following depletion of TCR-?? T cells and B cells from non-mobilized, leukapheresis products. Additionally, this study will attempt to describe occurrence of disease relapse and to describe the occurrence of post-transplant re- activation and/or infections with viruses such as CMV, and EBV.

Tracking Information

NCT #
NCT03939585
Collaborators
Not Provided
Investigators
Principal Investigator: Folashade Otegbeye, MD University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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