Chronic Graft-versus-host Disease Clinical Trial
Official title:
Phase II Trial Evaluating the Safety and Efficacy of Rituximab as Primary Treatment for Extensive Chronic Graft Versus Host Disease
Verified date | January 2016 |
Source | Northside Hospital, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Rituximab is an attractive agent to bring to the upfront treatment of chronic graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has significant activity in cGVHD when utilized early in the course of the process. In addition, the investigators hope to show that the early use of Rituximab may allow for the earlier discontinuation of immunosuppression while obviating the need for long courses of systemic corticosteroids, which should translate into reduced treatment-related morbidity and mortality associated with cGVHD.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | February 2016 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - First episode of extensive chronic GvHD, without residual or concurrent acute GvHD. - Age 18 - 75 - Any primary diagnosis requiring treatment by allogeneic HSCT - Recipient of an allogeneic stem cell transplant (bone marrow, peripheral blood stem cell, or cord blood) from a related or unrelated donor, minimum 80 days ago - Conditioning regimen: Myeloablative or non-myeloablative - Patient gives written informed consent Exclusion Criteria: - Creatinine > 2.0 mg/dl - Uncontrolled, active infection - Recurrent or progressive malignancy - Anticipated life expectancy of less than 1 year - Pregnant or breast feeding - Contraindications to administration of the study intervention or known inability of the patient to tolerate the study intervention - Patients with perceived fixed, irreversible defects (pulmonary involvement, contractures, etc.) which would not be expected to improve with the study intervention - Residual or concurrent acute GVHD |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northside Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Northside Hospital, Inc. | Blood and Marrow Transplant Group of Georgia |
United States,
Canninga-van Dijk MR, van der Straaten HM, Fijnheer R, Sanders CJ, van den Tweel JG, Verdonck LF. Anti-CD20 monoclonal antibody treatment in 6 patients with therapy-refractory chronic graft-versus-host disease. Blood. 2004 Oct 15;104(8):2603-6. Epub 2004 Jul 13. — View Citation
Cutler C, Miklos D, Kim HT, Treister N, Woo SB, Bienfang D, Klickstein LB, Levin J, Miller K, Reynolds C, Macdonell R, Pasek M, Lee SJ, Ho V, Soiffer R, Antin JH, Ritz J, Alyea E. Rituximab for steroid-refractory chronic graft-versus-host disease. Blood. 2006 Jul 15;108(2):756-62. Epub 2006 Mar 21. — View Citation
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Stewart BL, Storer B, Storek J, Deeg HJ, Storb R, Hansen JA, Appelbaum FR, Carpenter PA, Sanders JE, Kiem HP, Nash RA, Petersdorf EW, Moravec C, Morton AJ, Anasetti C, Flowers ME, Martin PJ. Duration of immunosuppressive treatment for chronic graft-versus-host disease. Blood. 2004 Dec 1;104(12):3501-6. Epub 2004 Aug 3. — View Citation
Zaja F, Bacigalupo A, Patriarca F, Stanzani M, Van Lint MT, Filì C, Scimè R, Milone G, Falda M, Vener C, Laszlo D, Alessandrino PE, Narni F, Sica S, Olivieri A, Sperotto A, Bosi A, Bonifazi F, Fanin R; GITMO (Gruppo Italiano Trapianto Midollo Osseo). Treatment of refractory chronic GVHD with rituximab: a GITMO study. Bone Marrow Transplant. 2007 Aug;40(3):273-7. Epub 2007 Jun 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Complete Response of cGVHD to Treatment. | 2 years | Yes | |
Primary | Rate of Overall Response of cGVHD to Treatment | 2 years | Yes | |
Primary | Rate of Partial Response of cGVHD to Treatment | 2 years | Yes | |
Secondary | Requirement for Systemic Corticosteroid Use | 2 years | No | |
Secondary | Time to Immunosuppression Withdrawal | 2 years | No | |
Secondary | Incidence of Overall Survival | 2 years | No | |
Secondary | Duration of Systemic Corticosteroid Use | 2 years | No | |
Secondary | Incidence of Disease-free Survival | 2 years | No | |
Secondary | Incidence of Non-relapse Mortality | 2 years | No |
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