Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies
NCT02743351 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2023-02-08
Summary
This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.
Conditions
- Hematologic Malignancies
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Myelodysplastic Syndromes
- Chronic Myelogenous Leukemia
- Acute Graft-versus-host Disease
Interventions
- BIOLOGICAL
-
ProTmune
Ex-vivo, programmed mobilized peripheral blood (mPB) cells
- BIOLOGICAL
-
Control Arm
Untreated mobilized peripheral blood (mPB) cells
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Sarah Cooley, MD · Fate Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-12-20
- Primary Completion
- 2020-12-04
- Completion
- 2021-11-05
Countries
- United States
Study Locations
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