Gene Therapy Clinical Trials
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.
Stanford Investigator(s):
Intervention(s):
- 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
Eligibility
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
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 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)
- 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
Ages Eligible for Study
18 Years - 76 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kate Tierney
6507257063
Not Recruiting