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Natural Killer Cells in Allogeneic Cord Blood Transplantation
This phase I trial studies the side effects and best way to give natural killer cells and donor umbilical cord blood transplant in treating patients with hematological malignancies. Giving chemotherapy with or without total body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Details
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 13 |
| Start date | 2013-05-03 |
| Completion | 2021-11 |
Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Biphenotypic Leukemia
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia in Remission
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- DS Stage II Plasma Cell Myeloma
- DS Stage III Plasma Cell Myeloma
- High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- ISS Stage II Plasma Cell Myeloma
- ISS Stage III Plasma Cell Myeloma
Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Cyclophosphamide
- Fludarabine Phosphate
- Laboratory Biomarker Analysis
- Lenalidomide
- Melphalan
- Mycophenolate Mofetil
- Natural Killer Cell Therapy
- Rituximab
- Tacrolimus
Primary outcomes
- Generation of a minimum of 5 x 10^6 natural killer/kg cells in at least 60% of patients (success rate) — Up to 1 year
Will be estimated with 90% credible interval. - Treatment-related mortality — 100 days
The method described by Thall, et al will be used. Will be estimated with 90% credible interval. The product-limit estimator of Kaplan and Meier will be used with 95% confidence intervals. - Incidence of adverse events graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 — Up to 1 year
Changes from baseline in vital signs and laboratory values will be summarized. Tabulate adverse events by severity and relationship to therapy.
Countries
United States