RDCRN 6502: A Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis after Allogeneic Hematopoietic Cell Transplantation
Study Status
Open to Enrollment
Study Description
This clinical trial is for people who have received a hematopoietic cell transplant (HCT) and who have developed symptoms of cutaneous sclerosis within the past 12 months. The purpose of the study is to determine if cutaneous sclerosis improves with treatment with either rituximab or imatinib.
Cutaneous sclerosis (CS) can cause damaging changes in the skin, joints and some internal organs. CS occurs in almost 16% of HCT transplant patients within 5 years after transplant. The current way to treat CS is to use high doses of steroids, which help control CS symptoms in about half of the people treated. Long term steroid use can result in bone damage and serious infections. Therefore there is a need to find a better way to treat CS that does not require high doses of steroids.
Rituximab is FDA approved to treat rheumatoid arthritis and certain types of cancers like non-Hodgkin lymphoma and chronic lymphocytic leukemia. Imatinib is FDA approved to treat certain types of cancers (chronic myeloid leukemia) and gastrointestinal tumors. Using rituximab and imatinib for treating CS is not FDA approved and is therefore experimental.
Study participants will be randomly assigned to take either:
- Rituximab via infusion once a week for the first 4 weeks, and then once a week for weeks 90 days after the first set of infusions
- Imatinib (as a pill taken by mouth) for at least 6 months; if imatinib is controlling a participant’s CS, they will continue taking imatinib for another 6 months (up to 1 year total)
There is no placebo used in this study. If the study drug a participant is assigned to is not helping with symptoms of CS at 3 month and 6 month assessments, the study physician may stop the current treatment and start treatment with the other study drug. This is called “crossover.”
Disease Status and/or Stage
Cutaneous Sclerosis after Hematopoietic Cell Transplant (HCT); blood disorders; rituximab; imatinib; Sebastian Mayer MD; Weill Cornell Bone Marrow Transplant; stem cell transplant; New York Presbyterian Hospital
Sponsor
NIH, GVHD Consortium
Key Eligibility
- Men and women age 2-99
- Diagnosis of cutaneous sclerosis after hematopoietic cell transplant (HTC)
- No more than 12 months since diagnosis of cutaneous sclerosis
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- June Greenberg, RN
- (212) 746-2651
- [email protected]
- Bone Marrow Transplant Medical Practice
- (212) 746-2119
Protocol ID
RDCRN 6502
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
