Trial · NCT01309997

Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease

NCT01309997, Phase 2, Completed, Lee, Stephanie; results first posted 2016-06-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease. Trials, record NCT01309997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01309997

On this page

Trial

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

Title: Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host Disease
NCT number: NCT01309997
Status: Completed
Phases: Phase 2
Enrollment: 72 participants, actual
Lead sponsor: Lee, Stephanie
Conditions: Graft Versus Host Disease, Systemic Scleroderma
Interventions: imatinib mesylate, rituximab
First posted: 2011-03-07
Last updated: 2016-06-15
Results first posted: 2016-06-15

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Significant Clinical Response	6 months	Assessed by decline in an affected area's skin score as measured with the Vienna Skin Scale (from 4 \[worst\] to 2, 3 to 1, or 2 to 0 \[best\]) without a concurrent increase of two or more points in another area OR by an increase in the range of motion of the shoulders, elbows or wrists by two points (in a 1-7 scale where 1 is worst and 7 is best) or of the ankles by one point (in a 1 to 4 scale where 1 is worst and 4 is best) without a concurrent worsening in another area.
Secondary	Patients Who Were Able to Taper Corticosteroids	6 months	Patients who achieved a greater than or equal to 50% reduction in the daily corticosteroid dose at 6mo compared to baseline
Secondary	Cumulative Incidence of Treatment Failure	6 months	Defined as discontinuation of randomized treatment due to chronic GVHD progression or treatment intolerance or no significant clinical response in sclerosis.
Secondary	Number of Patients Achieving Improvement in Cutaneous Sclerosis	6 months	Assessed by decrease of \>= 0.2 units (where 0 is best and 3.0 is worst ) in the Scleroderma Health Assessment Questionnaire (SHAQ).
Secondary	Baseline Histopathologic Score in the Two Treatment Arms	Enrollment	Instrument: Nash dermal fibrosis grade. Measures extent of sclerosis in skin biopsies by histologic examination. Scale ranges from grade 0-5. Nash grade 5 is most severe fibrosis (0 is better outcome, 5 is worse outcome). No subscales are used in Nash grade. Please see table 1 in the reference for grading of dermal fibrosis. Nash RA, McSweeney PA, Crofford LJ, Abidi M, Chen CS, Godwin JD, et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for severe systemic sclerosis: long-term follow-up of the US multicenter pilot study. Blood 2007;110:1388-96.
Secondary	Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale	6 months	Maximum of 10 body areas. Each area can be graded 0 (best) to 4 (worst). Each of those grades requires a percentage of involvement. Improvement is measured by reduction of involvement in any grade and any body area.
Secondary	Percentage of CD27+ B Cells in Responders (SCR) and Non-responders	6 months	%CD27+ B cells

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Significant Clinical Response	6 months	Patients were not eligible for evaluation if they discontinued participation or had missing 6 mo data.	participants	NUMBER
SECONDARY	Patients Who Were Able to Taper Corticosteroids	6 months	Patients with no corticosteroid dose data missing from baseline or 6mo.	participants	NUMBER
SECONDARY	Cumulative Incidence of Treatment Failure	6 months	Only patients who were evaluable for SCR are included.	participants	NUMBER
SECONDARY	Number of Patients Achieving Improvement in Cutaneous Sclerosis	6 months	Only patients evaluable at 6 mo are included.	participants	NUMBER
SECONDARY	Baseline Histopathologic Score in the Two Treatment Arms	Enrollment	Only patients with skin biopsies at enrollment are included.	units on a scale	MEDIAN
SECONDARY	Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale	6 months	Only patients who were evaluable at 6mo are included.	participants	NUMBER
SECONDARY	Percentage of CD27+ B Cells in Responders (SCR) and Non-responders	6 months		percentage of CD27+ B cells	MEAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Value	Spread	Units
Significant Clinical Response	Arm I (Enzyme Inhibitor)	9		participants
Significant Clinical Response	Arm II (Monoclonal Antibody)	10		participants
Patients Who Were Able to Taper Corticosteroids	Arm I (Enzyme Inhibitor)	7		participants
Patients Who Were Able to Taper Corticosteroids	Arm II (Monoclonal Antibody)	9		participants
Cumulative Incidence of Treatment Failure	Arm I (Enzyme Inhibitor)	24		participants
Cumulative Incidence of Treatment Failure	Arm II (Monoclonal Antibody)	26		participants
Number of Patients Achieving Improvement in Cutaneous Sclerosis	Arm 1 (Enzyme Inhibitor)	2		participants
Number of Patients Achieving Improvement in Cutaneous Sclerosis	Arm II (Monocolonal Antibody)	9		participants
Baseline Histopathologic Score in the Two Treatment Arms	Arm 1 (Enzyme Inhibitor)	2	Full Range 0 to 5	units on a scale
Baseline Histopathologic Score in the Two Treatment Arms	Arm II (Monoclonal Antibody)	2	Full Range 0 to 5	units on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow10

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Enzyme Inhibitor)	35
Overall Study	STARTED	Arm II (Monoclonal Antibody)	37
Overall Study	Remained on First Arm Only	Arm I (Enzyme Inhibitor)	16
Overall Study	Remained on First Arm Only	Arm II (Monoclonal Antibody)	14
Overall Study	Crossed Over to Second Arm	Arm I (Enzyme Inhibitor)	19
Overall Study	Crossed Over to Second Arm	Arm II (Monoclonal Antibody)	23
Overall Study	COMPLETED	Arm I (Enzyme Inhibitor)	30
Overall Study	COMPLETED	Arm II (Monoclonal Antibody)	31
Overall Study	NOT COMPLETED	Arm I (Enzyme Inhibitor)	5
Overall Study	NOT COMPLETED	Arm II (Monoclonal Antibody)	6

Source ClinicalTrials.gov

Adverse events260

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	Imatinib as Initial Therapy	1	35	1
other	Anemia	Blood and lymphatic system disorders	Rituximab as Initial Therapy	0	37	0
other	Anemia	Blood and lymphatic system disorders	Imatinib as Secondary Therapy	1	23	4
other	Anemia	Blood and lymphatic system disorders	Rituximab as Secondary Therapy	1	19	1
other	Infusion related reaction	General disorders	Imatinib as Initial Therapy	0	35	0
other	Infusion related reaction	General disorders	Rituximab as Initial Therapy	1	37	1
other	Infusion related reaction	General disorders	Imatinib as Secondary Therapy	0	23	0
other	Infusion related reaction	General disorders	Rituximab as Secondary Therapy	0	19	0
other	Pain	General disorders	Imatinib as Initial Therapy	0	35	0
other	Pain	General disorders	Rituximab as Initial Therapy	0	37	0

1 to 10 of 260Source ClinicalTrials.gov

See all 260 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Imatinib as Initial Therapy
Total, all-cause mortality	Rituximab as Initial Therapy
Total, all-cause mortality	Imatinib as Secondary Therapy
Total, all-cause mortality	Rituximab as Secondary Therapy
Total, other adverse events	Imatinib as Initial Therapy	12	35
Total, other adverse events	Rituximab as Initial Therapy	12	37
Total, other adverse events	Imatinib as Secondary Therapy	21	23
Total, other adverse events	Rituximab as Secondary Therapy	1	19
Total, serious adverse events	Imatinib as Initial Therapy	11	35
Total, serious adverse events	Rituximab as Initial Therapy	19	37

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26378033	RESULT

Source 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
P30CA015704	Cancer Center Support Grant	LYNCH, THOMAS JAMES	FRED HUTCHINSON CANCER CENTER	NATIONAL CANCER INSTITUTE	1985 to 2025	NIH RePORTER
U54CA163438	Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplants (HCT)	LEE, STEPHANIE J	FRED HUTCHINSON CANCER RESEARCH CENTER	NATIONAL CANCER INSTITUTE	2011 to 2014	NIH RePORTER

Trial comparisons5

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

Comparison	Source
Arm I (Enzyme Inhibitor) vs Arm II (Monoclonal Antibody): Patients Who Were Able to Taper Corticosteroids	Trial comparisons
Arm I (Enzyme Inhibitor) vs Arm II (Monoclonal Antibody): Significant Clinical Response	Trial comparisons
Arm 1 (Enzyme Inhibitor) vs Arm II (Monocolonal Antibody): Number of Patients Achieving Improvement in Cutaneous Sclerosis	Trial comparisons
Arm I (Enzyme Inhibitor) vs Arm II (Monoclonal Antibody): Patients With Any Percentage Decline in Any Grade of Sclerosis Without Increase in Percentage of Higher Grades of Sclerosis in Other Areas on the Vienna Skin Scale	Trial comparisons
Arm I (Enzyme Inhibitor) vs Arm II (Monoclonal Antibody): Cumulative Incidence of Treatment Failure	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/NCT01309997

GET https://conductscience.org/api/trials/v1/NCT01309997/events?page=2

API reference For AI assistants