The goal of this phase II clinical study is to learn about the safety of inotuzumab ozogamicin when given with fludarabine, with or without bendamustine, melphalan, and rituximab before and after a stem cell transplant. Researchers also want to learn if inotuzumab ozogamicin when given after a stem cell transplant can help control leukemia and lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab attaches to CD22-positive cancer cells in a targeted way and delivers ozogamicin to kill them. Giving chemotherapy before a bone marrow or peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor attack the body's normal cells (called graft-versus-host disease). Giving tacrolimus and mycophenolate mofetil before and after the transplant may stop this from happening. Fludarabine, bendamustine, melphalan, and rituximab are commonly given before stem cell transplants. Giving inotuzumab ozogamicin with chemotherapy may work better in treating patients with leukemia or lymphoma undergoing stem cell transplantation.
Additional locations may be listed on ClinicalTrials.gov for NCT03856216.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Issa F. Khouri
Phone: 713-745-0049
PRIMARY OBJECTIVE:
I. To assess the safety of the addition of inotuzumab ozogamicin 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 with ALL, aggressive lymphoma, indolent lymphoma in transformation, or those who have failed >= three small molecule inhibitors are assigned to Group I. Patients with indolent lymphoma who failed conventional treatment are assigned to Group II. Patients who are haploidentical or mismatched stem cell transplant recipients are assigned to Group III.
GROUP I: Patients 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. Patients receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients then receive cyclophosphamide IV days 3-4.
GROUP II: Patients 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. Patients receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients also receive rituximab IV over 4-6 hours on days -6, 1 and 8, and cyclophosphamide IV on days 3-4.
GROUP III: Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, and melphalan IV over 30 minutes on days -3 and -2. Patients then receive total body irradiation (TBI) over 30-40 minutes on day -1, bone marrow or peripheral blood progenitor cells IV on day 0, and cyclophosphamide IV over 3 hours on days 3-4.
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.
GVHD PROPHYLAXIS: All patients receive tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months and mycophenolate mofetil (MMF) PO or IV three times daily (TID) from day 5 to 60.
Patients undergo chest x-ray imaging and echocardiography (ECHO) during screening and bone marrow biopsy and aspiration during screening and as clinically indicated throughout the trial. Patients also may undergo positron emission tomography (PET) and computed tomography (CT) throughout the trial. Additionally, patients may optionally undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 12 months and at years 2 and 3 as clinically indicated.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorIssa F. Khouri
