Trial Search Results
Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Stanford is currently not accepting patients for this trial.
Collaborator: The Leukemia and Lymphoma Society
- Procedure: Total lymphoid irradiation
- Drug: Rituximab
- Drug: Anti-thymoglobulin, rabbit (ATG, rabbit ATG)
- Drug: Cyclosporine
- Drug: Mycophenylate mofetil
- Drug: Filgrastim
- Drug: Granisetron
- Drug: Solumedrol
- Drug: Acetaminophen
- Drug: Diphenhydramine
- Drug: Hydrocortisone
Recipient Inclusion 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
(Physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative
- Mantle cell lymphoma (MCL): Transplant physicians believe subject would benefit from
- 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
Recipient Exclusion Criteria:
- 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)
- 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
- HIV seropositivity
Ages Eligible for Study
18 Years - 76 Years
Genders Eligible for Study