CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Cyclophosphamide +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00789776
NCT00789776Phase 2Completed

A Phase I/II Study Evaluating the Safety and Efficacy of Adding a Single Prophylactic Donor Lymphocyte Infusion (DLI) of Natural Killer Cells Early After Nonmyeloablative, HLA-Haploidentical Hematopoietic Cell Transplantation - A Multi Center Trial

Fred Hutchinson Cancer Center·interventional·Posted Nov 13, 2008·Updated Jan 31, 2020

In Brief

A Phase 2 clinical trial evaluating Allogeneic Bone Marrow Transplantation, Cyclophosphamide, and 6 other interventions for Acute Lymphoblastic Leukemia and 15 related conditions. Completed, enrolled 41 participants across 3 sites.

Detailed Summary

This phase I/II trial studies the side effects and best dose of donor natural killer (NK) cell therapy and to see how well it works when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, donor bone marrow transplant, mycophenolate mofetil, and tacrolimus in treating patients with hematologic cancer. Giving chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow 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 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. Giving an infusion of the donor's T cells (donor lymphocyte infusion) may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and tacrolimus after the transplant may stop this from happening.

Study Details

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2008
Enrollment StartOct 13, 2008
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 17.6 years ago

Interventions

Allogeneic Bone Marrow Transplantationprocedure

Undergo donor bone marrow transplantation

Cyclophosphamidedrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given PO

Natural Killer Cell Therapybiological

Given IV

Tacrolimusdrug

Given IV or PO

Total-Body Irradiationradiation

Undergo total-body irradiation