Lymphoma Clinical Trial
Official title:
Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
RATIONALE: Giving an infusion of natural killer cells from a donor after a donor stem cell
transplant may help kill any remaining cancer cells after the transplant.
PURPOSE: This phase I/II trial is studying the side effects and best dose of donor natural
killer cells when given after a donor stem cell transplant in treating patients with
advanced cancer.
OBJECTIVES:
Primary
- To assess the safety of donor natural killer (NK) cell infusion after
HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a
familial donor in patients with advanced malignant disorders.
- To determine the maximum number of donor NK cells that can be safely given to these
patients.
Secondary
- To assess the clinical efficacy donor NK cell infusion, in terms of tumor response,
response duration, and survival, in patients with progressive or recurrent malignant
disorders.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
- Phase I: Patients receive an infusion of donor natural killer (NK) cells on days 18 and
21.
- Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After
completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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