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A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease

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ClinicalTrials.gov Identifier: NCT00760981
Recruitment Status : Unknown
Verified February 2010 by Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : September 26, 2008
Last Update Posted : February 19, 2010
Information provided by:
Stanford University

Brief Summary:
To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Drug: Imatinib Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease
Study Start Date : September 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Primary Outcome Measures :
  1. The frequency of adverse events graded according to the CTCAE will be the primary endpoint [ Time Frame: Subjects will be monitored at 1, 4, 8, 16, and 24 weeks. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:A. Subject has cGVHD requiring systemic therapy occurring >100 days after hematopoietic cell transplant diagnosed with at least one diagnostic feature from Appendix A.

B. Subject has active cGVHD with either:

  1. Persistent steroid dependence defined as the inability to taper steroid treatment to less than 0.25 mg/kg/d prednisone or its equivalent for at least 3 months
  2. Progression of cGVHD signs and symptoms on steroid therapy equivalent to prednisone 0.5 mg/kg/d for at least 1 month.

C. Subject has at least one of the following manifestations with which to follow progression of disease or response to imatinib:

  1. Skin changes (rash, sclerosis, fasciitis, or ulceration)
  2. Abnormal eye wetness <= 5 mm as measured by Schirmer's test
  3. Oral mucosal changes (erythema, lichenoid changes, ulcers, or mucoceles)
  4. Thrombocytopenia (platelets <150,000/uL).
  5. Abnormal liver function testing (alkaline phosphatase, AST, ALT, or total bilirubin > ULN).
  6. Bronchiolitis obliterans (diagnosed by a > 5% annual decline in FEV1 with the lowest post-transplant FEV1/FVC < 0.8 and an appropriate CT scan or lung biopsy, see Appendix A for details)

D. Subject may have previously any received immunosuppressive therapies for cGVHD. Continuing treatment with steroids and any one or none of the following is allowed: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or extracorporeal photopheresis.

E. Subject has been on a fixed dose of steroids or a fixed dose of steroids and one other immunosuppressant (cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or extracorporeal photopheresis) for >= 30 days before starting imatinib.

F. Subject has a life expectancy >= 6 months.

G. Subject has the ability to understand and willingness to sign a written informed consent document.

H. Subject has a Karnofsky performance status^3 50% (Appendix B).

I. Subject is ³ 18 years of age.

J. If a female with reproductive potential (defined as having at least 1 menstrual period in the past 12 months), the subject must have a negative pregnancy test performed <= 7 days before starting study drug.

K. If a female with reproductive potential, the subject agrees to use contraception for the duration of the trial.

L. Subject has a total bilirubin < 1.5X ULN.

M. Subject has an aspartate transaminase (AST), alanine aminotransferase (ALT), and alkaline phosphatase < 2.5X ULN.

N. Subject has an absolute neutrophil count > 500/uL (growth factor supplementation is allowed).

O. Subject has a hematocrit > 26% (transfusion support is allowed).

P. Subject has a platelet count > 20,000/uL.

Exclusion Criteria:A. Subject has received another investigational agent <= 30 days before starting the study drug.

B. Subject has an on-going, intercurrent illness such as an infection not responsive to antibiotics, antiviral medicines, or antifungal medicines.

C. Subject has progressive malignant disease.

D. Subject has a secondary malignancy that has not been effectively treated within the past 5 years (except localized basal cell or squamous cell carcinoma).

E. Subject has imatinib intolerance or allergy.

F. Subject is breast-feeding.

G. Subject is not willing to comply with treatment or response evaluation.

H. Subject has received an allogeneic cell product (including DLI or hematopoietic cell boost) <= 100 days before starting study drug.

I. The subject's steroid and/or immunosuppressant dose has changed <= 30 days before starting study drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760981

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Washington
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Stanford University
Principal Investigator: David Miklos Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Miklos, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00760981     History of Changes
Other Study ID Numbers: SU-07112008-1254
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: February 19, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action