CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies
Condition: Hematopoietic and Lymphoid Cell Neoplasm
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase I/II trial studies the side effects and the best dose of inotuzumab ozogamicin
      when given together with fludarabine phosphate, bendamustine hydrochloride, and rituximab
      before donor stem cell transplant in treating patients with lymphoid malignancies. Giving
      chemotherapy drugs, such as fludarabine phosphate and bendamustine hydrochloride, before a
      donor peripheral blood stem cell transplant helps stop the growth of cancer cells or abnormal
      cell and helps stop the patient's immune system from rejecting the donor's stem cells.
      Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and rituximab, may
      help the body's immune system attack the cancer, and may interfere with the ability of tumor
      cells to grow and spread. When the healthy stem cells from a donor are infused into the
      patient they may help the patient's bone marrow make stem cells, red blood cells, white blood
      cells, and platelets. Sometimes the transplanted cell from a donor can make an immune system
      response against the body's normal cells. Giving fludarabine phosphate and bendamustine
      hydrochloride before the transplant together with anti-thymocyte globulin and tacrolimus may
      stop this from happening.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To characterize the safety of anti-cluster of differentiation (CD) 22 immunoconjugate
      inotuzumab ozogamicin (CMC-544), when administered in conjunction with fludarabine
      (fludarabine phosphate), bendamustine (bendamustine hydrochloride), and rituximab as
      non-myeloablative preparative regimen for allogeneic stem cell transplantation for
      CD22-positive lymphoid malignancies.

      SECONDARY OBJECTIVES:

      I. To estimate tumor response. II. To determine overall and event-free survival rates by
      histology subtype.

      OUTLINE: This is a dose-escalation study of inotuzumab ozogamicin.

      Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, and
      fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1
      hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6
      hours on days -6, 1, and 8 and patients with matched unrelated donors (MUD) receive
      anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive
      tacrolimus IV over 24 hours continuously or orally (PO) daily beginning on days -2 to 180
      followed by taper in the absence of graft-versus-host disease (GVHD) and methotrexate IV over
      30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo
      allogeneic bone marrow (BM) or peripheral blood stem cell (PBSC) transplant on day 0.

      After completion of study treatment, patients are followed up periodically.
    

Intervention name(s): Allogeneic Bone Marrow Transplantation; Allogeneic Hematopoietic Stem Cell Transplantation; Anti-Thymocyte Globulin; Bendamustine Hydrochloride; Fludarabine Phosphate; Inotuzumab Ozogamicin; Methotrexate; Peripheral Blood Stem Cell Transplantation; Rituximab; Tacrolimus
Intervention type(s): Procedure; Procedure; Biological; Drug; Drug; Biological; Drug; Procedure; Biological; Drug
Intervention description(s): Undergo allogeneic BM transplant; Undergo allogeneic PBSC or BM transplant; Given IV; Given IV; Given IV; Given IV; Given IV; Undergo allogeneic PBSC transplant; Given IV; Given IV or PO
Other intervention name(s): Allo BMT; Allogeneic BMT; Allogeneic Hematopoietic Cell Transplantation; Allogeneic Stem Cell Transplantation; HSC; HSCT; Antithymocyte Globulin; Antithymocyte Serum; ATG; ATGAM; ATS; Thymoglobulin; Bendamustin Hydrochloride; Cytostasan Hydrochloride; Levact; Ribomustin; SyB L-0501; Treanda; 2-F-ara-AMP; 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-; Beneflur; Fludara; SH T 586; Besponsa; CMC-544; Way 207294; WAY-207294; 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; PBPC transplantation; PBSCT; Peripheral Blood Progenitor Cell Transplantation; Peripheral Stem Cell Support; Peripheral Stem Cell Transplant; Peripheral Stem Cell Transplantation; 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; Inotuzumab Ozogamicin; Methotrexate; Fludarabine; Fludarabine phosphate; Bendamustine Hydrochloride; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment