Fludarabine, Bendamustine, and Rituximab in Treating Participants With Lymphoid Cancers Undergoing Stem Cell Transplant
Condition: CD20 Positive; Chronic Lymphocytic Leukemia; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; T-Cell Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the best dose and how well bendamustine works with standard
      chemotherapy (fludarabine, rituximab) in treating participants with lymphoid cancers
      undergoing stem cell transplant. Drugs used in chemotherapy, such as fludarabine,
      bendamustine, and rituximab, work in different ways to stop the growth of cancer cells,
      either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer
      cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells.
      When the healthy stem cells from a donor are infused into the participant, they may help the
      participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
      Sometimes, the transplanted cells from a donor can make an immune response against the body's
      normal cells called graft versus host disease. Giving rituximab and methotrexate after the
      transplant may stop this from happening.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine engraftment and dose limiting toxicity (DLT) of bendamustine in patients with
      lymphoid malignancies undergoing non-myeloablative allogeneic hematopoietic transplantation.

      SECONDARY OBJECTIVES:

      I. To monitor the risk of graft-versus-host disease (GVHD) and clinical responses.

      OUTLINE: This is a dose escalation study of bendamustine.

      Participants receive rituximab intravenously (IV) over 5-7 hours on days -13 and -6,
      fludarabine IV over 1 hour and bendamustine IV over 1 hour on days -5 to -3, and tacrolimus
      IV starting on day -2 and orally (PO) after hospital discharge for 6 to 8 months.
      Participants with matched unrelated donor (MUD) receive thymoglobulin on days -2 and -1.
      Participants undergo allogenic stem cell transplant over 30-45 minutes on day 0. Participants
      receive rituximab IV over 5-7 hours on days 1 and 8 and methotrexate IV over 30 minutes on
      days 1, 3, and 6. Participants with MUD also receive methotrexate IV on day 11. Participants
      receive filgrastim (G-CSF) subcutaneously (SC) once daily starting on day 7 until white blood
      cell counts recover.

      After completion of study treatment, participants are followed up every 3 months during year
      1 and every 6 months for up to 3 years.
    

Intervention name(s): Allogeneic Hematopoietic Stem Cell Transplantation; Anti-Thymocyte Globulin; Bendamustine; Filgrastim; Fludarabine; Methotrexate; Rituximab; Tacrolimus
Intervention type(s): Procedure; Biological; Drug; Biological; Drug; Drug; Biological; Drug
Intervention description(s): Undergo ASCT; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV; Given IV and PO
Other intervention name(s): Allogeneic Hematopoietic Cell Transplantation; Allogeneic Stem Cell Transplantation; HSC; HSCT; Antithymocyte Globulin; Antithymocyte Serum; ATG; ATGAM; ATS; Thymoglobulin; SDX-105; FILGRASTIM, LICENSE HOLDER UNSPECIFIED; G-CSF; Neupogen; r-metHuG-CSF; Recombinant Methionyl Human Granulocyte Colony Stimulating Factor; rG-CSF; Tevagrastim; Fluradosa; Abitrexate; Alpha-Methopterin; Amethopterin; Brimexate; CL 14377; CL-14377; Emtexate; Emthexat; Emthexate; Farmitrexat; Fauldexato; Folex; Folex PFS; Lantarel; Ledertrexate; Lumexon; Maxtrex; Medsatrexate; Metex; Methoblastin; Methotrexate LPF; Methotrexate Methylaminopterin; Methotrexatum; Metotrexato; Metrotex; Mexate; Mexate-AQ; MTX; Novatrex; Rheumatrex; Texate; Tremetex; Trexeron; Trixilem; WR-19039; ABP 798; BI 695500; C2B8 Monoclonal Antibody; Chimeric Anti-CD20 Antibody; CT-P10; IDEC-102; IDEC-C2B8; IDEC-C2B8 Monoclonal Antibody; MabThera; Monoclonal Antibody IDEC-C2B8; PF-05280586; Rituxan; Rituximab Biosimilar ABP 798; Rituximab Biosimilar BI 695500; Rituximab Biosimilar CT-P10; Rituximab Biosimilar GB241; Rituximab Biosimilar IBI301; Rituximab Biosimilar PF-05280586; Rituximab Biosimilar RTXM83; Rituximab Biosimilar SAIT101; RTXM83; FK 506; Fujimycin; Hecoria; Prograf; Protopic
Intervention MeSH terms: Rituximab; Antineoplastic Agents, Immunological; Methotrexate; Fludarabine; Bendamustine Hydrochloride; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Lenograstim; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment