Nonmyeloablative Haploidentical Transplant Followed by MLN9708
NCT02169791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2021-09-02
Summary
In an attempt to reduce relapse risk and improve outcomes following haploidentical transplantation for patients with high risk hematologic malignancies, the investigators will implement several strategies to augment the well documented effect of NK cell alloreactivity seen in HLA-mismatched transplantation. These strategies include (1) choosing potential haploidentical donors for optimal NK-alloreactivity, (2) utilizing proteasome inhibition post-transplant with MLN9708 to both sensitize tumor cells to NK cytotoxicity and protect against graft-versus-host disease (GVHD), and (3) eliminating mycophenolate mofetil from the post-transplant immunosuppression regimen to improve NK cell reconstitution following haploidentical peripheral blood stem cell transplantation.
Conditions
- Acute Leukemia
- Chronic Leukemia
- Myelodysplastic Syndrome
- Lymphomas
- Multiple Myeloma
Interventions
- DRUG
-
MLN9708
MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant.
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
collaborator INDUSTRY -
Northside Hospital, Inc.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-15
- Primary Completion
- 2020-07-28
- Completion
- 2020-07-28
Countries
- United States
Study Locations
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