4 and older, any sex, with Sclerotic Graft Versus Host Disease or Imatinib Mesylate. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent Change in Absolute Range of Motion (ROM) From Baseline to 6 MonthsPrimary· 6 months
A change in ROM is 25% or greater from baseline. A partial response required improvement in 25% or more in ROM. Progression required 25% or greater loss of ROM.Patients with negative values in the Table are those who lost ROM. Percent improvement in ROM for 1-3 target joints. For patients with \>1 target joint, the average ROM improvement was calculated. The average percentage change in ROM deficit from baseline to 6 months was obtained based on the number of degrees of ROM change (6 months)/total ROM deficit (baseline) at each joint.
Pt 2 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
94
Pt 7 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
35
Pt 8 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
16
Pt10 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
21
Pt12 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
16
Pt13 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
61
Pt14 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
27
Pt15 6mo response% change in deficit from baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
22
Primary Range of Motion (ROM) ResponsePrimary· 6 months
Progressive disease is defined as joint ROM: decrease of \>25% in composite ROM score on 2 consecutive evaluations at least 2 weeks apart, but not greater than 4 weeks apart or steroid pulse: \>1 steroid pulse per 3 month period if administered for sclerotic-type chronic graft versus host disease (ScGVHD). Response is joint ROM: increase of \>25% in composite ROM score. Maximal response is a response with no further improvement over 2 sequential 3-month evaluations. Stable disease does not meet the criteria for progression, response, or maximal response.
Partial Response
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
5
Stable Disease
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
7
Progressive Disease
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
2
Number of Participants With Adverse EventsSecondary· Date treatment consent signed to date off study, approximately, 41 months, 27 days
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
20
Average Percentage Change in Range of Motion (ROM) DeficitSecondary· 6 months
One or more joints were assessed for ROM deficit by a physiatrist with expertise in graft versus host disease and joint ROM.
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
24.2
15.5 – 30.5
Total Skin Score at Baseline and 6 MonthsSecondary· Baseline and 6 Months
Total skin score was graded by the National Institutes of Health Consensus Criteria. Skin score was calculated by dividing the total score by seven domains (skin, eye, oral, joint, gastrointestinal, hepatic, pulmonary) in men and 8 domains in women (previous domains noted plus gynecologic). Total skin score is a percentage of body surface area (BSA) involvement (range 0-100%). It was calculated from the sum of moveable body surface BSA and non-moveable BSA. Higher numbers = greater body surface area affected.
Patient # 2 - Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
66.6
Patient # 2 - 6 months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
54
Patient # 3 - Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
43.38
Patient # 3 - 6 months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
NA
Patient # 7 - Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
66.24
Patient # 7 - 6 months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
55.53
Patient # 8 - Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
53.1
Patient # 8 - 6 months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
55.26
Total Chronic Graft Versus Host Disease (cGVHD) Provider Global Rating Score at Baseline and 6 MonthsSecondary· Baseline and 6 months
The provider global rating is a physician impression of severity of cGVHD symptoms from a scale of zero (no symptoms) to 10 (most severe GVHD symptoms possible).
Patient #2 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
5
Patient #2 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
4
Patient #3 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
3
Patient #3 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
NA
Patient #7 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
6
Patient #7 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
8
Patient #8 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
6
Patient #8 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
7
Lung Function Score at Baseline and 6 MonthsSecondary· Baseline and 6 Months
Lung function was graded by the National Institutes of Health Chronic Graft Versus Host Disease organ response criteria. The Lung function score = forced expiratory volume 1 (FEV1) score + carbon monoxide diffusing capacity (DLCO) score, with a possible range of 2 (better outcome)-12 (worst outcome). The percent predicted FEV1 and DLCO (adjusted for hematocrit but not alveolar volume) should be converted to a numeric score as follows: \>80% =1; 70-79% = 2; 60-69% = 3; 50-59% = 4; 40-49% = 5; \<40% = 6.
Patient #2 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
2
Patient #2 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
2
Patient #3 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
9
Patient #3 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
NA
Patient #7 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
3
Patient #7 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
8
Patient #8 at Baseline
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
5
Patient #8 at 6 Months
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
6
Change in ImmunosuppressionSecondary· 6 months
Change in immunosuppression was defined by an increase or decrease in steroid use form baseline.
↓ Pred 20 mg everyday (qd )to 5 mg every other day
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
1
↓ MPred 16 mg every other day(qod) to 4 mg qod
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
1
↓ Pred:24mg every day(qd) to 20mg qd
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
1
No change
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
5
↓ Tacro 2mg every am 1.5mg every pm to .5mg bid
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
1
Pred↓ 25mg qd to 15mg qd;Tacro↓ 2mg bid to 1mg bid
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
1
Pred↓ 2.5mg qd to 2.5mg every other day
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
1
↓ Siro:2mg qd to 1 mg qd
Group
Value
95% CI
Imatinib Mesylate in Patients With cGVHD
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately, 41 months, 27 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Imatinib Mesylate in Patients With cGVHD
Serious: 5/20 (25%)
Deaths: 0/20
Serious adverse events (13 terms)
Reaction
System
Imatinib Mesylate in Patie…
Dyspnea (shortness of breath)
Respiratory, thoracic and mediastinal disorders
—
Pulmonary/Upper Respiratory - Other (Specify, Pulmonary edema)
Respiratory, thoracic and mediastinal disorders
—
Edema::head and neck
General disorders
—
Edema: limb
General disorders
—
Edema:: trunk/genital
General disorders
—
Hypertension
Vascular disorders
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
Infection with unknown ANC::Lung (pneumonia)
Infections and infestations
—
Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized
Background:
Chronic graft-versus-host disease (GVHD) is a common complication of stem cell transplant, resulting from the donor's immune cells attacking the cells of the body of the recipient. One effect of GVHD is fibrosis (scarring) of the skin that can lead to impaired function, decreased quality of life and increased risk of death. This is known as sclerotic skin changes of GVHD, or sclerodermatous graft versus host disease (ScGVHD).
Imatinib mesylate (Gleevec) is a drug that has been approved by the Food and Drug Administration to treat cancer in humans and fibrosing conditions in animals.
Objectives:
To see if imatinib mesylate can improve ScGVHD and evaluate its effect on other GVHD symptoms
To assess the side effects of imatinib mesylate in patients with GVHD
To evaluate blood, body fluids and tissue samples in patients to try to better understand the biology of ScGVHD
Eligibility:
Patients 4 years of age and older with ScGVHD
Design:
Initial treatment: Participants take imatinib mesylate tablets once a day for up to 6 months, as long as their GVHD does not get worse and they do not develop unacceptable side effects of the drug.
Evaluations: Participants are evaluated at 1, 3 and 6 months at the National Institutes of Health (NIH) Clinical Center with procedures that may include the following:
Medical history and physical examination
Blood and urine tests
Lung function test
Skin biopsy
Magnetic resonance imaging (MRI) scan
Specialty consultations (e.g., physical or rehabilitative therapy, dentist, eye doctor, dermatologist)
Electrocardiogram (EKG)
Echocardiogram (ultrasound test of the heart)
Muga scan (nuclear medicine test of the heart)
Quality-of-life questionnaires
Apheresis (procedure for collecting quantities of white blood cells)
Office visits with local physician once a week for 1 month, then once every 2 weeks for 5 months
Followup visits at National Institutes of Health (NIH) every 6 months for 1 year
Continuing treatment: Patients who improve continue to receive imatinib mesylate for up to 6 months after their best response and are followed for up to 2 years. Patients who continue to respond or who become worse after stopping treatment may receive additional treatment for up to 2 years.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem
· Phase 1, PHASE2
· recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After
· Phase 1
· not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 30 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00702689.