Obinutuzumab in Preventing Chronic Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant

Inclusion Criteria

• Subjects deemed potentially eligible by their treating physicians will be screened for enrollment after d+60 from transplantation
• Patients who have undergone either ablative or non-myeloablative allogeneic stem cell transplantation are eligible
• Peripheral blood stem cells must have been used as the stem cell source
• Patients must have received transplantation from donors (both related and unrelated) who are identical at 8 HLA loci (A, B, C and DRbeta1), or mismatched at no more than 1 locus (7/8); among related donors, HLA C typing is not required (6/6 HLA matches); class I typing is to be performed by polymerase chain reaction (PCR)-sequence specific primers (SSP) techniques and complement-dependent cytotoxicity (CDC) techniques; class II typing is performed by PCR-restriction fragment length polymorphism (RFLP) +/- PCR-SSP techniques
• No evidence of relapsed or residual malignancy within 30 days of trial entry; all patients must undergo appropriate staging for their malignancy (i.e. bone marrow aspiration for the leukemias and positron emission tomography [PET]-computed tomography [CT] scanning for the lymphomas); evidence of a persistent cytogenetic abnormality will constitute evidence of residual or relapsed disease in the leukemias, where present; individuals with chronic lymphocytic leukemia (CLL) are eligible if there is no more than 20% residual leukemia in the bone marrow at the time of study entry
• Patients who have undergone a non-myeloablative stem cell transplant must have > 80% donor hematopoiesis within 30 days of study enrollment; chimerism within 30 days of study entry must be greater than, equal to, or no more than 5% less than the chimerism measured at approximately day +30 (if performed)
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• White blood cell (WBC) >= 2,500/uL
• Absolute neutrophil count >= 1,000/uL
• Platelets >= 50,000/uL
• Ability to understand and the willingness to sign a written informed consent document
• The effects of obinutuzumab on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of obinutuzumab administration

Exclusion Criteria

• Allogeneic stem cell transplantation using a single or multiple umbilical cord blood units or using bone marrow
• Allogeneic stem cell transplantation using in vivo or ex vivo T cell depletion, either by cell manipulation or with T cell depleting antibodies (any anti-thymocyte globulin preparation or alemtuzumab given within 30 days of transplantation)
• Participation in a clinical trial evaluating another preventative strategy for chronic graft-versus-host disease (GVHD), or ongoing participation in a clinical trial for therapy of acute GVHD; prior completion of experimental therapy for acute GVHD is permissible if the experimental agent was used > 30 days prior to enrollment
• Any evidence of ongoing gastrointestinal or hepatic acute GVHD, or evidence of greater than ongoing stage I cutaneous acute GVHD; ongoing, tapering therapy for resolved acute GVHD is permissible
• Any evidence of prior active or resolved chronic GVHD
• Any evidence of cGVHD or late acute graft versus host disease (aGVHD) between enrollment and first dose of obinutuzumab
• History of severe allergic reaction to obinutuzumab
• No donor lymphocyte infusion (DLI) prior to day 100, and no plans for a DLI in the upcoming 30 days
• Evidence of any active uncontrolled infection (bacterial, viral or fungal) or evidence of natural exposure to hepatitis B, hepatitis C or human immunodeficiency virus (HIV); evidence of hepatitis B exposure includes the presence of hepatitis B surface antigenemia, a positive serological test for hepatitis B core antibody or nucleic acid testing (NAT testing) that is positive for hepatitis B; vaccination to hepatitis B is not an exclusion criteria; testing done in the pre-transplant setting is sufficient to rule out infection
• Pregnancy or lactation; negative pregnancy test is required within the screening window for women of child bearing potential
• Active use of any other investigational agents