Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
Public ClinicalTrials.gov record NCT00397813. 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
Low-Dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection After Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders - A Multi-Center Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD). Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
Study identification
- NCT ID
- NCT00397813
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 77 participants
Conditions and interventions
Conditions
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- Chronic Myelomonocytic Leukemia
- de Novo Myelodysplastic Syndrome
- Essential Thrombocythemia
- Myeloproliferative Neoplasm
- Paroxysmal Nocturnal Hemoglobinuria
- Polycythemia Vera
- Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase
- Primary Myelofibrosis
- Refractory Anemia
- Refractory Anemia With Excess Blasts
- Refractory Anemia With Ring Sideroblasts
- Refractory Cytopenia With Multilineage Dysplasia
- Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts
Interventions
- Cyclosporine Drug
- Fludarabine Phosphate Drug
- Laboratory Biomarker Analysis Other
- Mycophenolate Mofetil Drug
- Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Procedure
- Peripheral Blood Stem Cell Transplantation Procedure
- Total-Body Irradiation Radiation
Drug · Other · Procedure + 1 more
Eligibility (public fields only)
- Age range
- 50 Years to 75 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
- Dec 31, 2005
- Primary completion
- Aug 31, 2017
- Completion
- Feb 28, 2018
- Last update posted
- Jan 30, 2020
2006 – 2018
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| LDS Hospital | Salt Lake City | Utah | 84143 | — |
| Veterans Administration Center-Seattle | Seattle | Washington | 98108 | — |
| 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 NCT00397813, 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 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00397813 live on ClinicalTrials.gov.