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.

Trial Details

NCT ID
NCT03104491
Phase
PHASE1 / PHASE2
Sponsor
Leland Metheny
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Inotuzumab Ozogamicin
Locations (sample)
  • Westwood, Kansas, United States|39.04056,-94.6169
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Omaha, Nebraska, United States|41.25626,-95.94043
  • New York, New York, United States|40.71427,-74.00597
  • Cleveland, Ohio, United States|41.4995,-81.69541

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Leukemia Trials on Trialify →