Trial · NCT00224874

Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)

NCT00224874, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2010-04-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302). Trials, record NCT00224874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00224874

On this page

Trial

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

Title: Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)
NCT number: NCT00224874
Status: Completed
Phases: Phase 2
Enrollment: 180 participants, actual
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Conditions: Graft vs Host Disease, Immune System Disorders
Interventions: Etanercept, Mycophenolate Mofetil, Denileukin Diftitox, Pentostatin
First posted: 2005-09-23
Last updated: 2021-11-01
Results first posted: 2010-04-09

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Number of Complete Response (CR) at Day 28 of Therapy	Measured at Day 28	Complete response at day 28 after randomization. CR was defined as resolution of all signs and symptoms of Graft-Versus-Host Disease (GVHD) in all evaluable organs in comparison to Day 1 scoring.
Secondary	Number of Partial Response (PR), Mixed Response (MR), and Progression	Measured at Day 28	Partial response, mixed response, and progression at Day 28 after randomization. Partial response was defined as improvement in one or more organs involved with Graft-Versus-Host Disease (GVHD) symptoms without progression in others. Mixed response was defined as improvement in one or more organs with deterioration in another organ manifesting symptoms of GVHD or development of symptoms of GVHD in a new organ. Progression was defined as deterioration in at least one organ without any improvement in others.
Secondary	Proportion of Treatment Failure	Measured at Day 56
Secondary	Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90	Measured at Day 90	Flares were defined as any increase in symptoms of or therapy for acute GVHD after an initial response (i.e., progression from an earlier CR or PR).
Secondary	Number of Patients Discontinuing Immune Suppression Without Flare	Measured at Days 90, 180, and 270 post-treatment	Immunosuppression discontinuation was defined as the discontinuation of corticosteroids and all additional immunosuppressives, except cyclosporine or tacrolimus, for treatment of acute GVHD without subsequent flare by Day 90 post-initiation of therapy and later by discontinuation of all immunosuppressive medications, including cyclosporine or tacrolimus.
Secondary	Number of Patients With Chronic Graft-versus-host Disease (GVHD)	Measured at 9 months	Number of patients with limited and extensive chronic GVHD at 9 months
Secondary	Number of Patients Surviving at 6 and 9 Months Post Randomization	Measured at 6 and 9 months
Secondary	Cumulative Incidence of Systemic Infections	Measured at Day 270
Secondary	Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma	Measured at 9 months

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Complete Response (CR) at Day 28 of Therapy	Measured at Day 28	All patients randomized were included in the analysis on an intent-to-treat basis	participants	NUMBER
SECONDARY	Number of Partial Response (PR), Mixed Response (MR), and Progression	Measured at Day 28	All patients randomized were included in the analysis on an intent-to-treat basis	participants	NUMBER
SECONDARY	Proportion of Treatment Failure	Measured at Day 56		percentage of participants	NUMBER
SECONDARY	Number of Patients With Acute Graft-versus-host Disease (GVHD) Flares at Day 90	Measured at Day 90	All patients randomized were included in the analysis on an intent-to-treat basis	participants	NUMBER
SECONDARY	Number of Patients Discontinuing Immune Suppression Without Flare	Measured at Days 90, 180, and 270 post-treatment	All patients randomized were included in the analysis on an intent-to-treat basis	participants	NUMBER
SECONDARY	Number of Patients With Chronic Graft-versus-host Disease (GVHD)	Measured at 9 months	All patients randomized were included in the analysis on an intent-to-treat basis	participants	NUMBER
SECONDARY	Number of Patients Surviving at 6 and 9 Months Post Randomization	Measured at 6 and 9 months	All patients randomized were included in the analysis on an intent-to-treat basis	participants	NUMBER
SECONDARY	Cumulative Incidence of Systemic Infections	Measured at Day 270		percentage of participants	NUMBER
SECONDARY	Incidence of Epstein-Barr Virus (EBV)-Associated Lymphoma	Measured at 9 months	No data collected

Source ClinicalTrials.gov

Results by group52

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

Outcome	Group	Category	Value	Units
Number of Complete Response (CR) at Day 28 of Therapy	Etanercept		12	participants
Number of Complete Response (CR) at Day 28 of Therapy	Mycophenolate Mofetil		27	participants
Number of Complete Response (CR) at Day 28 of Therapy	Denileukin Diftitox		25	participants
Number of Complete Response (CR) at Day 28 of Therapy	Pentostatin		16	participants
Number of Partial Response (PR), Mixed Response (MR), and Progression	Etanercept	Partial Response	10	participants
Number of Partial Response (PR), Mixed Response (MR), and Progression	Mycophenolate Mofetil	Partial Response	8	participants
Number of Partial Response (PR), Mixed Response (MR), and Progression	Denileukin Diftitox	Partial Response	3	participants
Number of Partial Response (PR), Mixed Response (MR), and Progression	Pentostatin	Partial Response	10	participants
Number of Partial Response (PR), Mixed Response (MR), and Progression	Etanercept	Mixed Response	3	participants
Number of Partial Response (PR), Mixed Response (MR), and Progression	Mycophenolate Mofetil	Mixed Response	4	participants

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Etanercept	46
Overall Study	STARTED	Mycophenolate Mofetil	45
Overall Study	STARTED	Denileukin Diftitox	47
Overall Study	STARTED	Pentostatin	42
Overall Study	COMPLETED	Etanercept	46
Overall Study	COMPLETED	Mycophenolate Mofetil	45
Overall Study	COMPLETED	Denileukin Diftitox	46
Overall Study	COMPLETED	Pentostatin	42
Overall Study	NOT COMPLETED	Etanercept	0
Overall Study	NOT COMPLETED	Mycophenolate Mofetil	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events68

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
serious	Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Etanercept	0	46
serious	Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Mycophenolate Mofetil	0	45
serious	Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Denileukin Diftitox	0	47
serious	Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	Pentostatin	1	42
serious	Diarrhoea	Gastrointestinal disorders	Etanercept	0	46
serious	Diarrhoea	Gastrointestinal disorders	Mycophenolate Mofetil	0	45
serious	Diarrhoea	Gastrointestinal disorders	Denileukin Diftitox	0	47
serious	Diarrhoea	Gastrointestinal disorders	Pentostatin	1	42
serious	Intestinal perforation	Gastrointestinal disorders	Etanercept	1	46
serious	Intestinal perforation	Gastrointestinal disorders	Mycophenolate Mofetil	0	45

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Etanercept
Total, all-cause mortality	Mycophenolate Mofetil
Total, all-cause mortality	Denileukin Diftitox
Total, all-cause mortality	Pentostatin
Total, other adverse events	Etanercept	0	46
Total, other adverse events	Mycophenolate Mofetil	0	45
Total, other adverse events	Denileukin Diftitox	0	47
Total, other adverse events	Pentostatin	0	42
Total, serious adverse events	Etanercept	4	46
Total, serious adverse events	Mycophenolate Mofetil	2	45

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19443659	RESULT	PubMed
19925875	RESULT	PubMed
20541024	RESULT	PubMed
22383800	DERIVED	PubMed

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
U01HL069294	BMT Clinical Research Network Data Coordinating Center	HOROWITZ, MARY MARESCA	MEDICAL COLLEGE OF WISCONSIN	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2001 to 2010

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/NCT00224874

GET https://conductscience.org/api/trials/v1/NCT00224874/results?page=2

API reference For AI assistants