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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00770757 |
This study will test the safety and effectiveness CC-4047 (pomalidomide) in patients with advanced, steroid refractory graft-versus-host disease.
Condition | Intervention | Phase |
---|---|---|
Graft vs Host Disease |
Drug: CC-4047 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Open-Label, Single-Arm, PILOT Study of Safety and Efficacy of cc-4047 (Pomalidomide) in Patients With ADVANCED Chronic Graft Versus Host Disease Developing After Allogeneic Hematological Stem Cell Transplantation |
Estimated Enrollment: | 20 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: CC-4047
CC-4047 3 mg po daily for up to 12 months
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Chronic Graft vs. Host Disease is a major complication after allogeneic hematopoietic stem cell transplantation developing in 30 - 70% of patients. It is a multisystem alloimmune and autoimmune disorder with a negative impact on quality of life and functional status, increased need for extended immunosuppression and is the leading cause of late transplant related mortality.
CC-4047 is a novel immune modulatory drug that is a thalidomide analog with a 4,000 fold greater inhibition of TNF-α production related to thalidomide. Several features of CC-4047 suggest that this drug may be useful in treating chronic GVHD including in vitro suppression of TNF-α production, increasing Th1 and stimulation of IL-12 and sIL-Rα.
This study is a phase 2, open-label, single-arm, pilot study of efficacy and safety of CC-4047 in patients with advanced chronic GvHD who failed to achieve a response with high-dose corticosteroids or second line systemic immunosuppressive therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patient must meet all of the following inclusion criteria:
Exclusion Criteria:
Contact: John F. DiPersio, M.D., Ph.D. | 317-454-8304 | jdipersi@dom.wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63122 | |
Contact: John F. DiPersio, M.D., Ph.D. 314-454-8304 jdipersi@dom.wustl.edu | |
Sub-Investigator: Iskra Pusic, M.D. | |
Sub-Investigator: Edie Romvari, RN, MSN, FNP | |
Sub-Investigator: Camille N. Abboud, M.D. | |
Sub-Investigator: Amanda Cashen, M.D. | |
Sub-Investigator: Michael P. Rettig, Ph.D. | |
Sub-Investigator: Keith Stockerl-Goldstein, M.D. | |
Sub-Investigator: Geoffrey Uy, M.D. | |
Sub-Investigator: Ravi Vij, M.D. | |
Sub-Investigator: Peter Westervelt, M.D., Ph.D. | |
Sub-Investigator: Stephanie Bauer, RN, MSN, FNP | |
Sub-Investigator: George Bryant, ND | |
Sub-Investigator: Holly Comer, RN, FNP | |
Sub-Investigator: Eric Ruettgers, RN, FNP | |
Sub-Investigator: Feng Gao, M.D., Ph.D. |
Principal Investigator: | John F. DiPersio, M.D., Ph.D. | Washington Univerisity School of Medicine |
Responsible Party: | Washington University School of Medicine ( John DiPersio, M.D., Ph.D. ) |
Study ID Numbers: | 08-1093 |
Study First Received: | October 7, 2008 |
Last Updated: | November 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00770757 |
Health Authority: | United States: Food and Drug Administration |
Graft versus host disease Graft vs Host Disease Homologous wasting disease |
Immune System Diseases |