Trial · NCT00544115
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
NCT00544115, Phase 2, Active not recruiting, City of Hope Medical Center; results first posted 2023-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders. Trials, record NCT00544115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00544115
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
- NCT number
- NCT00544115
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 260 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Precancerous/Nonmalignant Condition
- Interventions
busulfan, cyclophosphamide, cyclosporine, etoposide, fludarabine phosphate, melphalan, methotrexate, mycophenolate mofetil, sirolimus, tacrolimus, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, total-body irradiation
- First posted
- 2007-10-16
- Last updated
- 2026-06-02
- Results first posted
- 2023-05-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neutrophil Engraftment - The Days Till ANC Recovery | Up to 180 days post transplant | The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is \> 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment. |
| Secondary | Two-year Overall Survival | Up to 2 years post transplant | Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neutrophil Engraftment - The Days Till ANC Recovery | Up to 180 days post transplant | Some patients had engraftment failure and some had missing data. Therefore, the overall number of participants analyzed in each regimen is less than the overall number in the Participant Flow module. | days | MEDIAN |
| SECONDARY | Two-year Overall Survival | Up to 2 years post transplant | 1 subject in Regimen II did not have transplant. | percentage of survival probability | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neutrophil Engraftment - The Days Till ANC Recovery | Regimen I | 17 | 95% Confidence Interval 11 to 39 | days | |
| Neutrophil Engraftment - The Days Till ANC Recovery | Regimen II | 16 | 95% Confidence Interval 13 to 21 | days | |
| Neutrophil Engraftment - The Days Till ANC Recovery | Regimen III | 15 | 95% Confidence Interval 8 to 36 | days | |
| Neutrophil Engraftment - The Days Till ANC Recovery | Regimen IV | 14 | 95% Confidence Interval 14 to 17 | days | |
| Neutrophil Engraftment - The Days Till ANC Recovery | Regimen V | 18 | 95% Confidence Interval 11 to 28 | days | |
| Neutrophil Engraftment - The Days Till ANC Recovery | Regimen VI | 16 | 95% Confidence Interval 16 to 16 | days | |
| Two-year Overall Survival | Regimen I | 58 | 95% Confidence Interval 45 to 69 | percentage of survival probability | |
| Two-year Overall Survival | Regimen II | 50 | 95% Confidence Interval 25 to 71 | percentage of survival probability | |
| Two-year Overall Survival | Regimen III | 54 | 95% Confidence Interval 45 to 62 | percentage of survival probability | |
| Two-year Overall Survival | Regimen IV | 50 | 95% Confidence Interval 6 to 84 | percentage of survival probability |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen I | 62 | |
| Overall Study | STARTED | Regimen II | 17 | |
| Overall Study | STARTED | Regimen III | 130 | |
| Overall Study | STARTED | Regimen IV | 4 | |
| Overall Study | STARTED | Regimen V | 40 | |
| Overall Study | STARTED | Regimen VI | 2 | |
| Overall Study | COMPLETED | Regimen I | 62 | |
| Overall Study | COMPLETED | Regimen II | 17 | |
| Overall Study | COMPLETED | Regimen III | 130 | |
| Overall Study | COMPLETED | Regimen IV | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,386
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 | Bone marrow cellularity | Blood and lymphatic system disorders | Regimen I | 1 | 62 | 1 |
| other | Bone marrow cellularity | Blood and lymphatic system disorders | Regimen II | 0 | 17 | 0 |
| other | Bone marrow cellularity | Blood and lymphatic system disorders | Regimen III | 1 | 130 | 1 |
| other | Bone marrow cellularity | Blood and lymphatic system disorders | Regimen IV | 0 | 4 | 0 |
| other | Bone marrow cellularity | Blood and lymphatic system disorders | Regimen V | 0 | 40 | 0 |
| other | Bone marrow cellularity | Blood and lymphatic system disorders | Regimen VI | 0 | 2 | 0 |
| other | Coagulation - Other (Specify, __) | Blood and lymphatic system disorders | Regimen I | 0 | 62 | 0 |
| other | Coagulation - Other (Specify, __) | Blood and lymphatic system disorders | Regimen II | 0 | 17 | 0 |
| other | Coagulation - Other (Specify, __) | Blood and lymphatic system disorders | Regimen III | 1 | 130 | 1 |
| other | Coagulation - Other (Specify, __) | Blood and lymphatic system disorders | Regimen IV | 0 | 4 | 0 |
1 to 10 of 1,386Source ClinicalTrials.gov
See all 1,386 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen I | 45 | 62 |
| Total, all-cause mortality | Regimen II | 14 | 17 |
| Total, all-cause mortality | Regimen III | 103 | 130 |
| Total, all-cause mortality | Regimen IV | 2 | 4 |
| Total, all-cause mortality | Regimen V | 32 | 40 |
| Total, all-cause mortality | Regimen VI | 1 | 2 |
| Total, other adverse events | Regimen I | 14 | 62 |
| Total, other adverse events | Regimen II | 4 | 17 |
| Total, other adverse events | Regimen III | 38 | 130 |
| Total, other adverse events | Regimen IV | 0 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source 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/NCT00544115
GET https://conductscience.org/api/trials/v1/NCT00544115/events?page=2