Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer
Condition: Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Nasal Type Extranodal NK/T-cell Lymphoma; Blastic Phase Chronic Myelogenous Leukemia; Contiguous Stage II Adult Burkitt Lymphoma; Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Contiguous Stage II Adult Lymphoblastic Lymphoma; Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Grade 3 Follicular Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Contiguous Stage II Small Lymphocytic Lymphoma; de Novo Myelodysplastic Syndromes; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Graft Versus Host Disease; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Myelodysplastic Syndromes; Splenic Marginal Zone Lymphoma; Stage I Adult Burkitt Lymphoma; Stage I Adult Diffuse Large Cell Lymphoma; Stage I Adult Diffuse Mixed Cell Lymphoma; Stage I Adult Diffuse Small Cleaved Cell Lymphoma; Stage I Adult Immunoblastic Large Cell Lymphoma; Stage I Adult Lymphoblastic Lymphoma; Stage I Adult T-cell Leukemia/Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Grade 3 Follicular Lymphoma; Stage I Mantle Cell Lymphoma; Stage I Marginal Zone Lymphoma; Stage I Mycosis Fungoides/Sezary Syndrome; Stage I Small Lymphocytic Lymphoma; Stage II Adult T-cell Leukemia/Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Mycosis Fungoides/Sezary Syndrome; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-cell Leukemia/Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Sezary Syndrome; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Waldenstrom Macroglobulinemia; Leukemia-Lymphoma, Adult T-Cell; Blast Crisis; Lymphomatoid Granulomatosis; Leukemia, Myeloid, Accelerated Phase; Lymphoma, Extranodal NK-T-Cell; Myelodysplastic Syndromes; Graft vs Host Disease; Syndrome; Recurrence
Intervention: rituximab; mycophenolate mofetil; tacrolimus; anti-thymocyte globulin; allogeneic hematopoietic stem cell transplantation; laboratory biomarker analysis; graft versus host disease prophylaxis/therapy; cyclophosphamide; fludarabine phosphate; busulfan; total-body irradiation; graft-versus-tumor induction therapy; immunosuppressive therapy
Intervention description: Given IV; Given IV or PO; Given IV; Given IV; Stem cell transplant; Correlative studies; Undergo graft versus host disease prophylaxis/therapy; Given PO or IV; Given IV; Given IV; Undergo TBI; Undergo graft-versus-tumor induction therapy; Undergo immunosuppressive therapy
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Busulfan; Rituximab; Fludarabine; Fludarabine phosphate; Tacrolimus; Thymoglobulin; Antilymphocyte Serum; Immunosuppressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well rituximab works in preventing acute
      graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for
      hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell
      transplant helps stop the growth of cancer cells. It may also stop the patient's immune
      system from rejecting the donor's stem cells. The donated stem cells may replace the
      patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor
      effect). Sometimes the transplanted cells from a donor can also make an immune response
      against the body's normal cells. Giving a monoclonal antibody, rituximab, together with
      anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the
      transplant may stop this from happening
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic
             myelogenous leukemia (CML) in accelerated phase or blast crisis, chronic lymphocytic
             leukemia (CLL), Non-Hodgkin lymphoma (NHL), myelodysplastic syndromes (MDS)
             (intermediate-2 or high-risk disease by International Pelvic Pain Society [IPPS])

          -  Patients with AML, ALL, or MDS scheduled for myeloablative conditioning should have =<
             10% blasts in bone marrow or peripheral blood at the start of conditioning

          -  Patients with AML, ALL, or CML scheduled for reduced intensity conditioning or
             non-myeloablative conditioning should be in complete morphologic remission at the
             start of conditioning (residual disease by flow cytometry or cytogenetics and/or
             incomplete recovery of neutrophil or platelet count are acceptable)

          -  Patients with CLL or NHL scheduled for reduced intensity or non-myeloablative
             conditioning should have no evidence of bulky disease (> 50% bone marrow involvement
             or masses > 10 cm) at the start of conditioning

          -  Fulfills all pulmonary, cardiac, renal, and hepatic criteria for standard-of-care
             matched unrelated donor (MUD) allogeneic HCT

          -  Men and women of reproductive potential must agree to use an acceptable method of
             birth control during treatment and for twelve months after stem cell transplantation

          -  Adequately matched unrelated donor available

          -  Written informed consent; written informed consent of the unrelated donor is required
             to participate in the optional studies

        Exclusion Criteria:

          -  Patient or donor infected with human immunodeficiency virus (HIV)

          -  Patient or donor with history of hepatitis B or C and/or positive serology consistent
             with previous hepatitis B or C infection (patients and/or donor who received Hepatitis
             B vaccination are acceptable)

          -  Patient or donor with active hepatitis B or C and/or detectable viral ribonucleic acid
             (RNA)

          -  More than 20,000 circulating CD20+ cells/uL

          -  Treatment with rituximab for any reason in the 12 months preceding HCT

          -  Patient scheduled for cord blood transplantation

          -  Presence of active uncontrolled infection at start of conditioning

          -  Presence of active central nervous system (CNS) disease (history of adequately treated
             CNS disease is acceptable)

          -  Presence of uncontrolled psychiatric disorder

          -  Patient unable to give informed consent

          -  Unrelated donor products received from the Deutsche Knochenmarkspenderdatei (DKMS)
             Registry are not eligible for the optional study