Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD
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)
To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days
 after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly
 the incidence of chronic graft-vs-host disease (cGvHD).
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