Trial · NCT01002742

Acute Graft-versus-Host Disease Treatment (BMT CTN 0802)

NCT01002742, Phase 3, Completed, Medical College of Wisconsin; results first posted 2016-05-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Acute Graft-versus-Host Disease Treatment (BMT CTN 0802). Trials, record NCT01002742. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01002742

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Trial

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

Title: Acute Graft-versus-Host Disease Treatment (BMT CTN 0802)
NCT number: NCT01002742
Status: Completed
Phases: Phase 3
Enrollment: 236 participants, actual
Lead sponsor: Medical College of Wisconsin
Conditions: Graft-versus-Host Disease, Immune System Disorders
Interventions: Mycophenolate Mofetil, Placebo
First posted: 2009-10-27
Last updated: 2023-01-04
Results first posted: 2016-05-27

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	GVHD-free Survival	Day 56	Success is defined as alive and free of GVHD at day 56 after randomization, all others are considered to be a study failure.
Secondary	Percentage of Surviving Participants With Complete Response (CR)	Days 14, 28, and 56	CR is defined as a score of 0 for the GVHD grading in all evaluable organs.
Secondary	Incidence of GVHD Flares Requiring Increased Therapy	Day 90	Flares are defined as any progression of acute GVHD after an initial response (i.e., earlier CR or PR) that requires re-escalation of steroid dosing, or initiation of additional topical or systemic therapy.
Secondary	Incidence of Discontinuation of Immune Suppression Without Flare	Day 56, Day 180 and Day 360 post-treatment
Secondary	Cumulative Steroid Dose	Days 28 and 56	The cumulative steroid dose for each patient will be calculated by adding the doses (end of each week's dose) for each of the first four weeks of treatment, divided by the number of days of survival during this interval. The cumulative steroid dose was calculated for all patients per treatment arm and compared.
Secondary	Incidence of Topical/Non-absorbable Therapy	Day 56
Secondary	Overall GVHD-free Survival Post-randomization	Months 6 and 12
Secondary	Incidence of Chronic GVHD	12 months post-randomization
Secondary	Incidence of Systemic Infections	6 Months	Number of participants that experienced at least one infection.
Secondary	Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma	12 months

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	GVHD-free Survival	Day 56		participants	NUMBER
SECONDARY	Percentage of Surviving Participants With Complete Response (CR)	Days 14, 28, and 56		percentage of participants	NUMBER
SECONDARY	Incidence of GVHD Flares Requiring Increased Therapy	Day 90		participants	NUMBER
SECONDARY	Incidence of Discontinuation of Immune Suppression Without Flare	Day 56, Day 180 and Day 360 post-treatment	No data collected
SECONDARY	Cumulative Steroid Dose	Days 28 and 56		mg/kg	NUMBER
SECONDARY	Incidence of Topical/Non-absorbable Therapy	Day 56		participants	NUMBER
SECONDARY	Overall GVHD-free Survival Post-randomization	Months 6 and 12		percentage of participants	NUMBER
SECONDARY	Incidence of Chronic GVHD	12 months post-randomization		percentage of participants	NUMBER
SECONDARY	Incidence of Systemic Infections	6 Months		participants	NUMBER
SECONDARY	Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma	12 months		participants	NUMBER

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group36

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

Outcome	Group	Category	Value	Units
GVHD-free Survival	Placebo	GVHD free	60	participants
GVHD-free Survival	Mycophenolate Mofetil	GVHD free	69	participants
GVHD-free Survival	Placebo	Study Failure	59	participants
GVHD-free Survival	Mycophenolate Mofetil	Study Failure	47	participants
Percentage of Surviving Participants With Complete Response (CR)	Placebo	Day 14	49.6	percentage of participants
Percentage of Surviving Participants With Complete Response (CR)	Mycophenolate Mofetil	Day 14	44	percentage of participants
Percentage of Surviving Participants With Complete Response (CR)	Placebo	Day 28	44.5	percentage of participants
Percentage of Surviving Participants With Complete Response (CR)	Mycophenolate Mofetil	Day 28	46.6	percentage of participants
Percentage of Surviving Participants With Complete Response (CR)	Placebo	Day 56	53.8	percentage of participants
Percentage of Surviving Participants With Complete Response (CR)	Mycophenolate Mofetil	Day 56	60.3	percentage of participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	119
Overall Study	STARTED	Mycophenolate Mofetil	117
Overall Study	COMPLETED	Placebo	119
Overall Study	COMPLETED	Mycophenolate Mofetil	116
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Mycophenolate Mofetil	1

Source ClinicalTrials.gov

Adverse events46

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
serious	Vomiting	Gastrointestinal disorders	Placebo	0	119
serious	Vomiting	Gastrointestinal disorders	Mycophenolate Mofetil	1	116	1
serious	Orthostatic hypotension	Vascular disorders	Placebo	0	119
serious	Orthostatic hypotension	Vascular disorders	Mycophenolate Mofetil	1	116	1
serious	Diarrhoea	Gastrointestinal disorders	Placebo	0	119
serious	Diarrhoea	Gastrointestinal disorders	Mycophenolate Mofetil	1	116	1
serious	Cerebellar ataxia	Nervous system disorders	Placebo	0	119
serious	Cerebellar ataxia	Nervous system disorders	Mycophenolate Mofetil	1	116	1
serious	Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Placebo	0	119
serious	Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Mycophenolate Mofetil	1	116	1

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Mycophenolate Mofetil
Total, other adverse events	Placebo	0	119
Total, other adverse events	Mycophenolate Mofetil	0	116
Total, serious adverse events	Placebo	13	119
Total, serious adverse events	Mycophenolate Mofetil	13	116

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25170121	RESULT	PubMed
32081787	DERIVED	PubMed

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
U24CA076518	A Data Resource for Blood and Marrow Transplants and Adoptive Cellular Therapy Research	SHAW, BRONWEN; MOSKOP, AMY M	MEDICAL COLLEGE OF WISCONSIN	NATIONAL CANCER INSTITUTE	1998 to 2025	NIH RePORTER
U01HL069294	BMT Clinical Research Network Data Coordinating Center	HOROWITZ, MARY MARESCA	MEDICAL COLLEGE OF WISCONSIN	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2001 to 2010	NIH RePORTER

Trial comparisons5

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

Comparison	Source
Mycophenolate Mofetil vs Placebo: Incidence of Systemic Infections	Trial comparisons
Mycophenolate Mofetil vs Placebo: Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma	Trial comparisons
Mycophenolate Mofetil vs Placebo: Incidence of Topical/Non-absorbable Therapy	Trial comparisons
Mycophenolate Mofetil vs Placebo: Incidence of GVHD Flares Requiring Increased Therapy	Trial comparisons
Mycophenolate Mofetil vs Placebo: 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/NCT01002742

GET https://conductscience.org/api/trials/v1/NCT01002742/results?page=2

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