Trial · NCT02248597

Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases

NCT02248597, Phase 2, Completed, Wake Forest University Health Sciences; results first posted 2023-10-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases. Trials, record NCT02248597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02248597

On this page

Trial

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

Title: Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
NCT number: NCT02248597
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Wake Forest University Health Sciences
Conditions: Graft Versus Host Disease, Hematopoietic/Lymphoid Cancer
Interventions: fludarabine phosphate, busulfan, cyclophosphamide, allogeneic hematopoietic stem cell transplantation, tacrolimus, mycophenolate mofetil
First posted: 2014-09-25
Last updated: 2023-10-11
Results first posted: 2023-10-11

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	12 Month Disease Free Survival Probability	At 12 months	The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier.
Secondary	Rate of Acute GvHD	12 months	Kaplan-Meier estimation of the rate of acute GvHD in the study population at one year with a 95% confidence interval.
Secondary	Overall Survival	At 12 months	The survival function will be estimated and plotted using the method of Kaplan and Meier.
Secondary	Progression Free Survival	At 12 months	Kaplan-Meier estimation of the percentage of patients who are alive without progressive disease at one year.
Secondary	Relapse-free Mortality	At 12 months	Non-relapse mortality will be defined as time from registration to death due to anything other than relapse of hematological malignancy. Patients who relapse will be treated as a competing risk.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	12 Month Disease Free Survival Probability	At 12 months	percentage of participants	NUMBER
SECONDARY	Rate of Acute GvHD	12 months	percentage of participants	NUMBER
SECONDARY	Overall Survival	At 12 months	percentage of participants	NUMBER
SECONDARY	Progression Free Survival	At 12 months	percentage of participants	NUMBER
SECONDARY	Relapse-free Mortality	At 12 months	days	MEAN

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
12 Month Disease Free Survival Probability	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	51.8	95% Confidence Interval 33.0 to 70.7	percentage of participants
Rate of Acute GvHD	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	51.8	95% Confidence Interval 30.0 to 70.7	percentage of participants
Overall Survival	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	66.7	95% Confidence Interval 45.7 to 81.1	percentage of participants
Progression Free Survival	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	51.8	95% Confidence Interval 31.9 to 68.5	percentage of participants
Relapse-free Mortality	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	86.8	95% Confidence Interval 63.4 to 95.7	days

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	27
Overall Study	COMPLETED	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	27
Overall Study	NOT COMPLETED	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	0

Source ClinicalTrials.gov

Adverse events172

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	Anemia	Blood and lymphatic system disorders	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	24	27	24
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	2	27	2
other	ALC decrease	Blood and lymphatic system disorders	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	2	27	2
other	Pancytopenia	Blood and lymphatic system disorders	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	2	27	2
other	Activated partial thromboplastin time prolonged	Investigations	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	6	27	6
other	Alanine aminotransferase increased	Investigations	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	7	27	7
other	Alkaline phosphatase increased	Investigations	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	5	27	5
other	Aspartate aminotransferase increased	Investigations	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	5	27	5
other	Bilirubin increased	Investigations	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	9	27	9
other	Cardiac troponin I increased	Investigations	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	2	27	2

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	13	27
Total, other adverse events	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	27	27
Total, serious adverse events	Treatment (Stem Cell Transplant With GVHD Prophylaxis)	27	27

Source ClinicalTrials.gov

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA012197	Cancer Center Support Grant	MESA, RUBEN A.	WAKE FOREST UNIVERSITY HEALTH SCIENCES	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.

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/NCT02248597

GET https://conductscience.org/api/trials/v1/NCT02248597/events?page=2

API reference For AI assistants