Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI); The Leukemia and Lymphoma Society
• Treatments: Acetaminophen; Antilymphocyte Serum; Cyclosporine; Cyclosporins; Diphenhydramine; Granisetron; Hydrocortisone; Lenograstim; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Promethazine; Rituximab; Thymoglobulin

Criteria

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