Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolimus in Treating Patients With Hematologic Cancer
Public ClinicalTrials.gov record NCT00789776. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00789776
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 41 participants
Conditions and interventions
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Aggressive Non-Hodgkin Lymphoma
- Diffuse Large B-Cell Lymphoma
- Previously Treated Myelodysplastic Syndrome
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Recurrent Indolent Adult Non-Hodgkin Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Plasma Cell Myeloma
- Recurrent Small Lymphocytic Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Refractory Hodgkin Lymphoma
- Refractory Plasma Cell Myeloma
- Refractory Small Lymphocytic Lymphoma
- Waldenstrom Macroglobulinemia
Interventions
- Allogeneic Bone Marrow Transplantation Procedure
- Cyclophosphamide Drug
- Fludarabine Phosphate Drug
- Laboratory Biomarker Analysis Other
- Mycophenolate Mofetil Drug
- Natural Killer Cell Therapy Biological
- Tacrolimus Drug
- Total-Body Irradiation Radiation
Procedure · Drug · Other + 2 more
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 12, 2008
- Primary completion
- Apr 30, 2017
- Completion
- Apr 30, 2017
- Last update posted
- Jan 30, 2020
2008 – 2017
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
| Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00789776, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2020 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00789776 live on ClinicalTrials.gov.