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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00624897 |
RATIONALE: Rituximab may be an effective treatment for acute graft-versus-host disease that did not responded to steroid therapy.
PURPOSE: This clinical trial is studying the side effects and how well rituximab works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.
Condition | Intervention |
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Cancer |
Drug: cyclosporine Drug: methylprednisolone Drug: prednisone Drug: rituximab Drug: tacrolimus |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | Chimeric Monoclonal CD-20 Antibody (Rituximab) for Steroid Refractory Acute Graft Versus Host Disease (SR-aGVHD): A Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on days 1, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity. Two weeks after completion of study therapy, patients achieving a partial response receive 4 more weekly doses of rituximab.
Patients continue corticosteroid therapy (i.e., methylprednisone IV at the study entry dose or an equivalent oral dose of prednisone) and immunosuppression (i.e., cyclosporine or tacrolimus) as prescribed for graft-versus-host disease (GVHD) prophylaxis until at least 1 week after completion of rituximab. In the event of acute GVHD improvement, corticosteroid therapy is tapered.
After completion of study therapy, patients are followed for up to 1 year.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute graft-versus-host disease (aGVHD) meeting the following criteria:
Steroid-refractory and meeting any of the following organ-staging criteria:
Grade II-IV aGVHD requiring systemic therapy within 24-48 hours of diagnosis
Have undergone hematopoietic stem cell transplantation for any indication and from any allogeneic graft and donor type (i.e., marrow or peripheral blood, matched-related or matched-unrelated) within the past 100 days
Patients failing to respond to second-line aGVHD treatment with infliximab or other second-line therapy are allowed
PATIENT CHARACTERISTICS:
No uncontrolled infection (i.e., documented bacterial, viral, or fungal infection within 72 hours prior to study entry)
More than 8 weeks since documentation of any of the following opportunistic infections:
PRIOR CONCURRENT THERAPY:
United States, Texas | |
Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Shehzana Hussaini 713-441-1954 | |
Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Rammurti Kamble, MD 713-394-6252 |
Study Chair: | Rammurti Kamble, MD | Baylor College of Medicine |
Study ID Numbers: | CDR0000582348, BCM-H-19734 |
Study First Received: | February 27, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00624897 |
Health Authority: | Unspecified |
graft versus host disease stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma |
stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma |
Blast Crisis Prednisone Sezary syndrome Cyclosporine Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Tacrolimus Small non-cleaved cell lymphoma Cyclosporins Lymphoma, large-cell, immunoblastic Preleukemia Neoplasm Metastasis Rhabdomyosarcoma Immunoglobulins |
Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Acute myelogenous leukemia Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Lymphoma, Non-Hodgkin Hairy cell leukemia Lymphoma, Follicular Sezary Syndrome Neuroblastoma |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Neuroprotective Agents Hormones Therapeutic Uses Antifungal Agents Dermatologic Agents Neoplasms by Histologic Type |
Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Enzyme Inhibitors Immunosuppressive Agents Protective Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |