A Phase 4, Open-Label, Randomized Study of Two Inotuzumab Ozogamicin Dose Levels in Adult Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia Eligible for Hematopoietic Stem Cell Transplantation and Who Have Risk Factor(s) for Veno-Occlusive Disease
Categories (click each to see list of all clinical trials associated with that category): Leukemia/Myelodysplastic syndromes (MDS)/Myeloproliferative disorders (MPD)
Current Status: Open to accrual
Phase: IV
Principal Investigator: Gundabolu, Krishna
Contact Information:
Amberley Proctor
+1 402-836-9171
amberley.proctor@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03677596?cond=NCT03677596&draw=2&rank=1#eligibility
Summary
Primary Objective(s):
To evaluate the rates of VOD and hematologic remission (CR/CRi) for 2 inotuzumab ozogamicin dose levels in adult patients with relapsed or refractory B-cell ALL who are eligible for HSCT and who are at higher risk for developing VOD post-HSCT.
Secondary Objective(s): Safety and efficacy of 2 inotuzumab ozogamicin dose levels.
Tertiary/Exploratory Objective(s): To collect banked biospecimens for exploratory research, unless prohibited by local regulations or ethics committee/Investigational Review Board decision.