Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Public ClinicalTrials.gov record NCT01028716. 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
Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.
Study identification
- NCT ID
- NCT01028716
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 46 participants
Conditions and interventions
Conditions
- Acute Biphenotypic Leukemia
- Acute Erythroid Leukemia in Remission
- Acute Leukemia in Remission
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukaemia With Prior Myelodysplastic Syndrome
- Acute Myeloid Leukemia in Remission
- Acute Myeloid Leukemia With FLT3/ITD Mutation
- Acute Myeloid Leukemia With Inv(3)(Q21Q26.2); RPN1-EVI1
- Acute Myeloid Leukemia With Multilineage Dysplasia
- Acute Myeloid Leukemia With t(6;9)
- Acute Undifferentiated Leukemia
- Adult Acute Lymphoblastic Leukemia in Complete Remission
- B Acute Lymphoblastic Leukemia With T(1;19)(Q23;P13.3); E2A-PBX1 (TCF3-PBX1)
- Ph+ ALL
- Burkitt Lymphoma
- Childhood Acute Lymphoblastic Leukemia in Complete Remission
- DS Stage II Plasma Cell Myeloma
- DS Stage III Plasma Cell Myeloma
- Myelodysplastic Syndrome
- Recurrent Anaplastic Large Cell Lymphoma
- Blasts Under 5 Percent of Bone Marrow Nucleated Cells
- Recurrent Follicular Lymphoma
- Recurrent Hodgkin Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Plasma Cell Myeloma
- Refractory Plasma Cell Myeloma
- Secondary Acute Myeloid Leukemia
- T Lymphoblastic Lymphoma
- Hematopoietic Cell Transplant Recipient
Interventions
- Cyclophosphamide Drug
- Filgrastim Biological
- Fludarabine Phosphate Drug
- Mycophenolate Mofetil Drug
- Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Procedure
- Peripheral Blood Stem Cell Transplantation Procedure
- Tacrolimus Drug
- Total-Body Irradiation Radiation
Drug · Biological · Procedure + 1 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
- May 18, 2010
- Primary completion
- Oct 6, 2021
- Completion
- Oct 6, 2021
- Last update posted
- Jan 22, 2023
2010 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | — |
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 NCT01028716, 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 22, 2023 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01028716 live on ClinicalTrials.gov.