Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation

Summary

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PRIMARY OBJECTIVE: I. To assess the safety of the addition of inotuzumab ozogamicin (IO) pre- and post-allogeneic transplantation in patients with CD22-positive hematological malignancies. SECONDARY OBJECTIVES: I. Overall survival, progression-free survival and relapse rates. II. Treatment-related m...

PRIMARY OBJECTIVE: I. To assess the safety of the addition of inotuzumab ozogamicin (IO) pre- and post-allogeneic transplantation in patients with CD22-positive hematological malignancies. SECONDARY OBJECTIVES: I. Overall survival, progression-free survival and relapse rates. II. Treatment-related mortality. III. Cumulative incidence of acute and chronic graft-versus-host disease (GVHD). OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I: Patients with acute lymphoblastic leukemia (ALL) receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -2, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients receiving stem cells from a matched unrelated donor (MUD), receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1 and not receive chemotherapy drugs. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients then receive methotrexate IV over 30 minutes on days 1, 3, 6, and 11 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal. Patients with CD22-positive cancer, receive rituximab IV over 4-6 hours on days 1 and 8. GROUP II: Patients with lymphoma receive inotuzumab ozogamicin IV over 1 hour on day -13, fludarabine IV over 1 hour and bendamustine IV over 30 minutes to 1 hour on days -5 to -3, and tacrolimus IV continuously beginning on day -2 then PO QD or BID for about 6 months. Patients receiving stem cells from a MUD, receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1 and not receive chemotherapy drugs. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients then receive rituximab IV over 4-6 hours on days 1 and 8, methotrexate IV over 30 minutes on days 1, 3, and 6, and filgrastim-sndz SC once a day beginning 1 week after the transplant. Patients who received a stem cell transplant from a MUD also receive methotrexate IV over 30 minutes on day 11. MAINTENANCE: Between 45 and 100 days after stem cell transplantation, all patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 2. Beginning 28 to 100 days after start of first cycle, patients receive inotuzumab ozogamicin IV over 1 hour on days 1 and 2 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

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