Trial · NCT00397813
Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
NCT00397813, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2018-10-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders. Trials, record NCT00397813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00397813
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
- NCT number
- NCT00397813
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- 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, Fludarabine Phosphate, Laboratory Biomarker Analysis, Mycophenolate Mofetil, Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation, Total-Body Irradiation
- First posted
- 2006-11-10
- Last updated
- 2020-01-31
- Results first posted
- 2018-10-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With HCT Failure. | 200 days | HCT failure will be defined as graft rejection (defined as \< 5% donor T-cell chimerism) or disease progression within 200 days of transplant. |
| Secondary | Number of Patients Who Had Infections | 1 year | Number of patients who experienced bacterial, fungal, or viral infections. |
| Secondary | Number of Patients Who Engrafted | 1 year | Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%. |
| Secondary | Number of Patients With Progression-free Survival | 1 year | Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia. |
| Secondary | Number of Patients With Relapse/Progression | 1 year | Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With HCT Failure. | 200 days | No patients were enrolled on arms A2 and A3 because dose escalation was never triggered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Had Infections | 1 year | No patients were enrolled on arms A2 and A3 because dose escalation was never triggered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Engrafted | 1 year | No patients were enrolled on arms A2 and A3 because dose escalation was never triggered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Progression-free Survival | 1 year | No patients were enrolled on arms A2 and A3 because dose escalation was never triggered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Relapse/Progression | 1 year | No patients were enrolled on arms A2 and A3 because dose escalation was never triggered. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With HCT Failure. | Arm A - Dose Level 1 | 4 | Participants | ||
| Number of Patients With HCT Failure. | Arm A - Dose Level 2 | 0 | Participants | ||
| Number of Patients With HCT Failure. | Arm A - Dose Level 3 | 0 | Participants | ||
| Number of Patients With HCT Failure. | Arm B - Dose Level 1 | 5 | Participants | ||
| Number of Patients With HCT Failure. | Arm B - Dose Level 2 | 3 | Participants | ||
| Number of Patients With HCT Failure. | Arm B - Dose Level 3 | 2 | Participants | ||
| Number of Patients Who Had Infections | Arm A - Dose Level 1 | 24 | Participants | ||
| Number of Patients Who Had Infections | Arm A - Dose Level 2 | 0 | Participants | ||
| Number of Patients Who Had Infections | Arm A - Dose Level 3 | 0 | Participants | ||
| Number of Patients Who Had Infections | Arm B - Dose Level 1 | 12 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - Dose Level 1 | 36 | |
| Overall Study | STARTED | Arm A - Dose Level 2 | 0 | |
| Overall Study | STARTED | Arm A - Dose Level 3 | 0 | |
| Overall Study | STARTED | Arm B - Dose Level 1 | 12 | |
| Overall Study | STARTED | Arm B - Dose Level 2 | 5 | |
| Overall Study | STARTED | Arm B - Dose Level 3 | 24 | |
| Overall Study | COMPLETED | Arm A - Dose Level 1 | 36 | |
| Overall Study | COMPLETED | Arm A - Dose Level 2 | 0 | |
| Overall Study | COMPLETED | Arm A - Dose Level 3 | 0 | |
| Overall Study | COMPLETED | Arm B - Dose Level 1 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events258
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Arm A - Dose Level 1 | 0 | 36 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A - Dose Level 2 | 0 | 0 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A - Dose Level 3 | 0 | 0 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B - Dose Level 1 | 1 | 12 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B - Dose Level 2 | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B - Dose Level 3 | 0 | 24 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Arm A - Dose Level 1 | 1 | 36 | 1 |
| other | Acute kidney injury | Renal and urinary disorders | Arm A - Dose Level 2 | 0 | 0 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Arm A - Dose Level 3 | 0 | 0 | 0 |
| other | Acute kidney injury | Renal and urinary disorders | Arm B - Dose Level 1 | 1 | 12 | 1 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - Dose Level 1 | 10 | 36 |
| Total, all-cause mortality | Arm A - Dose Level 2 | 0 | 0 |
| Total, all-cause mortality | Arm A - Dose Level 3 | 0 | 0 |
| Total, all-cause mortality | Arm B - Dose Level 1 | 10 | 12 |
| Total, all-cause mortality | Arm B - Dose Level 2 | 3 | 5 |
| Total, all-cause mortality | Arm B - Dose Level 3 | 9 | 24 |
| Total, other adverse events | Arm A - Dose Level 1 | 16 | 36 |
| Total, other adverse events | Arm A - Dose Level 2 | 0 | 0 |
| Total, other adverse events | Arm A - Dose Level 3 | 0 | 0 |
| Total, other adverse events | Arm B - Dose Level 1 | 9 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P01CA018029 | Adult Leukemia Research Center | HILL, GEOFFREY ROGER | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00397813
GET https://conductscience.org/api/trials/v1/NCT00397813/results?page=2