Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
Trial ID or NCT#
Status
Purpose
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Official Title
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
Eligibility Criteria
- * 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:
- 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Kate Tierney
6507257063
View on ClinicalTrials.gov