Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
ConditionAcute Lymphocytic Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age16-75
SponsorLeland Metheny
About this trial
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.
Eligibility criteria
Qualifiers
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.
Transplanted in hematologic first complete remission with evidence of minimal residual disease within 45 days of allogeneic transplantation
Disqualifiers
Patients with clinical evidence of disease progression prior to enrollment
Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)
Creatinine clearance < 30ml/min
Bilirubin > 2X institutional upper limit of normal
Trial design
Treatments tested in this trial
- Inotuzumab Ozogamicin
Treatment groups
44 Participants
are divided into 1 treatment groupSponsors and collaborators
Leland Metheny
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov