Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib
Public ClinicalTrials.gov record NCT00036738. 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
Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive Ph+ Acute Leukemia ? A Multi-center Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
Study identification
- NCT ID
- NCT00036738
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 28 participants
Conditions and interventions
Conditions
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Blastic Phase
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
- Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Chronic Phase of Disease
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Disease
Interventions
- Cyclosporine Drug
- Dasatinib Drug
- Fludarabine Phosphate Drug
- Imatinib Mesylate Drug
- Mycophenolate Mofetil Drug
- Nilotinib Drug
- Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Procedure
- Peripheral Blood Stem Cell Transplantation Procedure
- Therapeutic Allogeneic Lymphocytes Biological
- Total-Body Irradiation Radiation
Drug · Procedure · Biological + 1 more
Eligibility (public fields only)
- Age range
- Up to 70 Years
- 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
- Jul 13, 2001 (Actual)
- Primary completion
- Jul 2014 (Actual)
- Completion
- May 2018 (Actual)
- Last update posted
- Jan 29, 2020
2001 – 2018
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Presbyterian - Saint Lukes Medical Center - Health One | Denver | Colorado | 80218 | — |
| VA Puget Sound Health Care System | Seattle | Washington | 98101 | — |
| 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 NCT00036738, 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 29, 2020 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00036738 live on ClinicalTrials.gov.