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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryNeutrophil Engraftment - The Days Till ANC RecoveryUp 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.
SecondaryTwo-year Overall SurvivalUp 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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNeutrophil Engraftment - The Days Till ANC RecoveryUp to 180 days post transplantSome 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.daysMEDIAN
SECONDARYTwo-year Overall SurvivalUp to 2 years post transplant1 subject in Regimen II did not have transplant.percentage of survival probabilityNUMBER

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Neutrophil Engraftment - The Days Till ANC RecoveryRegimen I1795% Confidence Interval 11 to 39days
Neutrophil Engraftment - The Days Till ANC RecoveryRegimen II1695% Confidence Interval 13 to 21days
Neutrophil Engraftment - The Days Till ANC RecoveryRegimen III1595% Confidence Interval 8 to 36days
Neutrophil Engraftment - The Days Till ANC RecoveryRegimen IV1495% Confidence Interval 14 to 17days
Neutrophil Engraftment - The Days Till ANC RecoveryRegimen V1895% Confidence Interval 11 to 28days
Neutrophil Engraftment - The Days Till ANC RecoveryRegimen VI1695% Confidence Interval 16 to 16days
Two-year Overall SurvivalRegimen I5895% Confidence Interval 45 to 69percentage of survival probability
Two-year Overall SurvivalRegimen II5095% Confidence Interval 25 to 71percentage of survival probability
Two-year Overall SurvivalRegimen III5495% Confidence Interval 45 to 62percentage of survival probability
Two-year Overall SurvivalRegimen IV5095% Confidence Interval 6 to 84percentage of survival probability

Participant flow18

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDRegimen I62
Overall StudySTARTEDRegimen II17
Overall StudySTARTEDRegimen III130
Overall StudySTARTEDRegimen IV4
Overall StudySTARTEDRegimen V40
Overall StudySTARTEDRegimen VI2
Overall StudyCOMPLETEDRegimen I62
Overall StudyCOMPLETEDRegimen II17
Overall StudyCOMPLETEDRegimen III130
Overall StudyCOMPLETEDRegimen IV4

Adverse events1,386

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherBone marrow cellularityBlood and lymphatic system disordersRegimen I1621
otherBone marrow cellularityBlood and lymphatic system disordersRegimen II0170
otherBone marrow cellularityBlood and lymphatic system disordersRegimen III11301
otherBone marrow cellularityBlood and lymphatic system disordersRegimen IV040
otherBone marrow cellularityBlood and lymphatic system disordersRegimen V0400
otherBone marrow cellularityBlood and lymphatic system disordersRegimen VI020
otherCoagulation - Other (Specify, __)Blood and lymphatic system disordersRegimen I0620
otherCoagulation - Other (Specify, __)Blood and lymphatic system disordersRegimen II0170
otherCoagulation - Other (Specify, __)Blood and lymphatic system disordersRegimen III11301
otherCoagulation - Other (Specify, __)Blood and lymphatic system disordersRegimen IV040

Adverse event totals18

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityRegimen I4562
Total, all-cause mortalityRegimen II1417
Total, all-cause mortalityRegimen III103130
Total, all-cause mortalityRegimen IV24
Total, all-cause mortalityRegimen V3240
Total, all-cause mortalityRegimen VI12
Total, other adverse eventsRegimen I1462
Total, other adverse eventsRegimen II417
Total, other adverse eventsRegimen III38130
Total, other adverse eventsRegimen IV04

Papers0

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA033572Cancer Center Support GrantCARPTEN, JOHN D.BECKMAN RESEARCH INSTITUTE/CITY OF HOPENATIONAL CANCER INSTITUTE1985 to 2025

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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