Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
Leland Metheny
Summary
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.
Description
Study Design This is a Phase I/II study of inotuzumab ozogamicin for the treatment of patients who underwent allogeneic transplantation for ALL and have a high risk of relapse. The Phase I portion of this study will be a 3+3 dose escalation trial. This is followed by a phase 2 cohort at the recommended Phase 2 dose (RP2D). Participants will receive study treatment up to 4 cycles until relapse of disease, unacceptable toxicity, or death, whichever occurs first Phase I: Inotuzumab Ozogamicin Dosing Escalation Subjects will be assessed for safety and tolerability (including adverse events, serio…
Eligibility
- Age range
- 16–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 Min…
Interventions
- DrugInotuzumab Ozogamicin
Inotuzumab ozogamicin, IV, 28 day cycles Phase 1 dosages: Dose Level -2 (0.1 mg/m\^2) Dose Level -1 (0.2 mg/m\^2) Dose Level 0 (0.3 mg/m\^2) Dose Level 1 (0.4 mg/m\^2) Dose Level 2 (0.5 mg/m\^2) Dose Level 3 (0.6 mg/m\^2)
Locations (7)
- The University of Kansas Cancer CenterWestwood, Kansas
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of Nebraska Medical CenterOmaha, Nebraska
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterCleveland, Ohio