Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
Trial ID or NCT#
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation
- - Between 18 and 76 years of age - Chronic lymphocytic leukemia (CLL): - Unmutated IgG VH gene status - Mutated IgG VH genes (> 2% nucleotide change compared to somatic sequence) - Complete remission benefit most from allogeneic hematopoietic stem cell transplant (HSCT). (Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.) - Mantle cell lymphoma (MCL): Transplant physicians believe subject would benefit from allogeneic HSCT. - Adequate renal (Cr < 2.4 mg/dL) and hepatic (Bilirubin < 3.0 mg/dL, Aspartate aminotransferase (AST) < 100 IU) function. - Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. - All subjects must provide written informed consent Donor Inclusion Criteria: - Genotypically or phenotypically human leukocyte antigen (HLA)-identical. - Age < 76 unless cleared by institutional PI - Capable of giving written, informed consent. - Must consent to peripheral blood stem cell (PBSC) mobilization with G-CSF and apheresis Recipient
- - Recipient has a 9 of 10 or 10 of 10 HLA identical donor (high resolution molecular genotyping at HLA A, B, C and DrB1, and DQ) - Pregnancy - Lactating - Serious uncontrolled infection - HIV seropositivity - Hepatitis B or C seropositivity - Cardiac function: ejection fraction < 40% or uncontrolled cardiac failure - Pulmonary: Diffusing capacity - carbon monoxide (DLCO) < 50% predicted - Liver function abnormalities: elevation of bilirubin to ≥ 3 mg/dL and/or AST > 100 - Renal: creatinine > 2.4 - Karnofsky performance score ≤ 60% - Patients with poorly controlled hypertension (systolic blood pressure > 150 or diastolic blood pressure > 90 repeatedly). - Known life-threatening hypersensitivity to rituximab or other anti-B cell antibodies. - Inability to comply with the allogeneic transplant treatment. - Uncontrolled central nervous system (CNS) involvement with disease Donor Exclusion Criteria: - Identical twin to subject - Contra-indication to subcutaneous G-CSF at a dose of 16 mg/kg/d for 5 consecutive days - Serious medical or psychological illness - Prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers. - HIV seropositivity
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