Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
This study has two phases, Phase I and Phase II. The main goal of the Phase I portion of this research study is to see what doses post-transplant inotuzumab ozogamicin can safely be given to subjects without having too many side effects. The Phase II portion of this study is to see what side effects are seen with medication after transplant. Inotuzumab ozogamicin is a combination of an antibody and chemotherapy which has been shown to have significant activity against relapsed/refractory acute lymphocytic leukemia (ALL). Inotuzumab ozogamicin is considered experimental in this study.
• Phase 1 Inclusion Criteria
• Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
• Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia
• Patients who are between T+40 and T+100 after allogeneic transplantation. Patients must receive their first dose of inotuzumab at or before T+100.
• Patients who have/are either:
‣ Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation
∙ --Pre- or Post-Transplant Minimal Residual Disease defined by:
∙ ---Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.
⁃ In second or third complete remission at the time of allogeneic transplantation
⁃ Treated with reduced intensity regimens or non-myeloablative conditioning regimens
⁃ Lymphoid blast crisis of CML
⁃ Are relapsed or refractory to at least 1 line of chemotherapy
⁃ Philadelphia-like ALL
• Patients who have evidence of donor chimerism after allogeneic transplantation.
• ECOG Performance status \< 2
• Participants must have ANC \> 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µL for 7 days.
• Able to adhere to the study visit schedule and other protocol requirements.
• Participants must have the ability to understand and the willingness to sign a written informed consent document.
• Phase 2 Inclusion Criteria
• Diagnosis of CD22-positive Acute Lymphoblastic Leukemia
• Patients who underwent an allogeneic hematopoietic stem cell transplantation from any donor source for acute lymphocytic leukemia
• Patients who are between T+40 and T+100 after allogeneic transplantation
• Patients who have/are either:
‣ Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation
∙ --Post-Transplant Minimal Residual Disease defined by:
∙ ---Any detectable ALL (by flow cytometry, cytogenetics, or PCR techniques) as per clinical indication.
⁃ In second or third complete remission at the time of allogeneic transplantation
⁃ Treated with reduced intensity regimens as defined per institutional standard of practice
⁃ Lymphoid blast crisis of CML
⁃ Are relapsed or refractory to at least 1 line of chemotherapy
⁃ Philadelphia-like ALL
• Patients who have \> 80% donor chimerism after allogeneic transplantation.
• Philadelphia chromosome positive ALL must have failed at least 1 TKI
• ECOG Performance status \< 1
• pre-transplant evaluation, see 10.1.1
• Participants must have ANC \> 1,000/µL for 3 days and platelet transfusion independence as defined as a platelet count \> 50,000/µL for 7 days.
• Able to adhere to the study visit schedule and other protocol requirements.
• Participants must have the ability to understand and the willingness to sign a written informed consent document.