Inotuzumab Ozogamicin for treatment of pediatric BCP-ALL
Research type
Research Study
Full title
A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia.
IRAS ID
219932
Contact name
Donna Lancaster
Contact email
Sponsor organisation
Erasmus MC
Eudract number
2016-000227-71
Clinicaltrials.gov Identifier
NTR5736, NTR
Duration of Study in the UK
4 years, 1 months, 30 days
Research summary
Inotuzumab Ozogamizin (InO) has demonstrated activity in the treatment of adult Acute Lymphoblastic Leukenmia (ALL) patients. Given the medical need in pediatric relapse/refractory B cell precursor ALL (BCP-ALL), development of InO in pediatric ALL seems highly warranted. This study consists of a phase I study (stratum 1A) to establish the maximum tolerated dose (MTD) of fractionated InO in pediatric BCP-ALL patients, which starts at 80% of the fractionated dose in adults. This is followed by a non-randomized phase 2 study in the same population of patients to determine the overall response rate of single-agent InO and to collect additional safety and pharmacokinetic data at the MTD. In addition, an explorative arm (stratum 2) is added for patients with CD22-positive other B-cell malignancies. In stratum 2 patients no formal dose-escalation rules will apply. Stratum 2 patients will be treated at one dose level below stratum 1 dose escalation level. This arm may remain open until accrual for stratum 1 is completed. The next step will be to incorporate InO in an existing ALL regimen to determine safety in combination with re-induction chemotherapy (stratum 1B, which requires a protocol amendment at a later stage. This development plan is part of an approved Pediatric Investigational Plan. Treatment of children with InO may result in improvement of their disease state.
REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1622
Date of REC Opinion
1 Dec 2017
REC opinion
Further Information Favourable Opinion