Trial · NCT01349101

A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors

NCT01349101, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University; results first posted 2025-12-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors. Trials, record NCT01349101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01349101

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors
NCT number: NCT01349101
Status: Completed
Phases: Phase 2
Enrollment: 78 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Conditions: Hematological Malignancies
Interventions: Total Body Irradiation, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil, Fludarabine, Busulfan, Hematopoietic stem cell transplantation
First posted: 2011-05-06
Last updated: 2025-12-15
Results first posted: 2025-12-15

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Successful Engraftment Using Cyclophosphamide Post-Transplant	Through 100 days post-transplant	Successful Hematopoietic engraftment will be assessed by determining the incidence of participants who achieve both of the following criteria within the 100 days post-transplant: ANC \>/= 0.5x10e9/L for at least 3 days. Platelet engraftment \>20,000 with no transfusions X 7 days. The incidence will be calculated as the number of participants who meet both engraftment criteria. Results will be presented as a proportion/percentage/probability not as an incidence rate.
Secondary	Cumulative Incidence of Grade III-IV GVHD	Through 100 days post-transplant	The cumulative incidence of Grade III-IV graft-versus-host disease (GVHD) within 100 days post-transplant will be estimated; goal is less than 10%. The cumulative incidence represents the probability that a participant experiences Grade III-IV GVHD by day 100. Results will be reported as proportion/percentage/probability.
Secondary	Incidence of GVHD Unresponsive to Corticosteroids and Photopheresis	Through 100 days post-treatment	This outcome will estimate the cumulative incidence (probability) of graft-versus-host disease (GVHD) that is considered unresponsive to corticosteroids and photopheresis within 100 days after treatment; goal is less than 15%. The cumulative incidence will be calculated as the number of participants meeting these criteria. Results will be reported as a proportion/percentage.
Secondary	Transplant-Related Mortality	100 days post-transplant	The cumulative incidence of transplant related mortality (TRM) by day 100 post-transplant will be estimated. Assess day 100 transplant-related mortality; goal is less than 15%. TRM is defined as death that results from medical treatment rather than from the underlying disease itself. The cumulative incidence reflects the probability of TRM by day 100. The result will be reported as a proportion/percentage/probability, not an incidence rate.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Successful Engraftment Using Cyclophosphamide Post-Transplant	Through 100 days post-transplant	Cumulative Probability of Engraftment	NUMBER
SECONDARY	Cumulative Incidence of Grade III-IV GVHD	Through 100 days post-transplant	Cumulative Probability of Grade III-IV G	NUMBER
SECONDARY	Incidence of GVHD Unresponsive to Corticosteroids and Photopheresis	Through 100 days post-treatment	Cumulative Probability of GVHD	NUMBER
SECONDARY	Transplant-Related Mortality	100 days post-transplant	Cumulative Probability of Mortality	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Successful Engraftment Using Cyclophosphamide Post-Transplant	Myeloablative HSCT	1.00	95% Confidence Interval 1.00 to 1.00	Cumulative Probability of Engraftment
Successful Engraftment Using Cyclophosphamide Post-Transplant	Reduced Intensity HSCT	0.93	95% Confidence Interval 0.86 to 1.00	Cumulative Probability of Engraftment
Cumulative Incidence of Grade III-IV GVHD	Myeloablative HSCT	0.5152	95% Confidence Interval 0.3312 to 0.6716	Cumulative Probability of Grade III-IV G
Cumulative Incidence of Grade III-IV GVHD	Reduced Intensity HSCT	0.3111	95% Confidence Interval 0.1820 to 0.4493	Cumulative Probability of Grade III-IV G
Incidence of GVHD Unresponsive to Corticosteroids and Photopheresis	Myeloablative HSCT	0.0625	95% Confidence Interval 0.0107 to 0.1838	Cumulative Probability of GVHD
Incidence of GVHD Unresponsive to Corticosteroids and Photopheresis	Reduced Intensity HSCT	0.0233	95% Confidence Interval 0.00177 to 0.1072	Cumulative Probability of GVHD
Transplant-Related Mortality	Myeloablative HSCT	0.0909	95% Confidence Interval 0.0226 to 0.2192	Cumulative Probability of Mortality
Transplant-Related Mortality	Reduced Intensity HSCT	0.1951	95% Confidence Interval 0.0904 to 0.3292	Cumulative Probability of Mortality

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Myeloablative HSCT	33
Overall Study	STARTED	Reduced Intensity HSCT	45
Overall Study	COMPLETED	Myeloablative HSCT	29
Overall Study	COMPLETED	Reduced Intensity HSCT	36
Overall Study	NOT COMPLETED	Myeloablative HSCT	4
Overall Study	NOT COMPLETED	Reduced Intensity HSCT	9

Source ClinicalTrials.gov

Adverse events1,518

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 Distention - Grade 1	Musculoskeletal and connective tissue disorders	Myeloablative HSCT	1	33	1
other	Abdominal Distention - Grade 1	Musculoskeletal and connective tissue disorders	Reduced Intensity HSCT	3	45	3
other	Abdominal Distention - Grade 2	Musculoskeletal and connective tissue disorders	Myeloablative HSCT	1	33	1
other	Abdominal Distention - Grade 2	Musculoskeletal and connective tissue disorders	Reduced Intensity HSCT	2	45	2
other	Abnormal DLCO test - Grade 3	Respiratory, thoracic and mediastinal disorders	Myeloablative HSCT	0	33	0
other	Abnormal DLCO test - Grade 3	Respiratory, thoracic and mediastinal disorders	Reduced Intensity HSCT	1	45	1
other	Abrasion - Grade 1	Skin and subcutaneous tissue disorders	Myeloablative HSCT	0	33	0
other	Abrasion - Grade 1	Skin and subcutaneous tissue disorders	Reduced Intensity HSCT	1	45	1
other	Acute Kidney Injury - Grade 1	Renal and urinary disorders	Myeloablative HSCT	5	33	6
other	Acute Kidney Injury - Grade 1	Renal and urinary disorders	Reduced Intensity HSCT	9	45	10

1 to 10 of 1,518Source ClinicalTrials.gov

See all 1,518 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Myeloablative HSCT	3	33
Total, all-cause mortality	Reduced Intensity HSCT	8	45
Total, other adverse events	Myeloablative HSCT	33	33
Total, other adverse events	Reduced Intensity HSCT	45	45
Total, serious adverse events	Myeloablative HSCT	5	33
Total, serious adverse events	Reduced Intensity HSCT	5	45

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Myeloablative HSCT vs Reduced Intensity HSCT: deaths from any cause	Trial comparisons
Myeloablative HSCT vs Reduced Intensity HSCT: serious adverse events	Trial comparisons

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/NCT01349101

GET https://conductscience.org/api/trials/v1/NCT01349101/events?page=2

API reference For AI assistants