Inotuzumab Ozogamicin for pediatric CD22-positive relapsed/refractory A
Recruiting
- Conditions
- pediatric CD22-positive relapsed / refractory Acute Lymphoblastic Leukemia
- Registration Number
- NL-OMON27023
- Lead Sponsor
- ErasmusMC, Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 156
Inclusion Criteria
Age
Exclusion Criteria
Isolated extramedullary relapse
Patients with isolated extramedullary disease are excluded (not applicable to lymphoma patients except for isolated CNS-relapse)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In stratum 1A: Dose-limiting toxicities (DLTs) during the first course of therapy.<br><br /><br /><br>In phase 2 cohort: Overall Response Rate, measured as best response during InO treatment<br /><br /><br><br>Stratum 2: Safety and tolerability<br><br /><br /><br><br>Stratum 1B and 1B-ASP: Dose-limiting toxicities (DLTs) during the first cycle of InO when added to a modified UKALL-R3 re-induction chemotherapy regimen without or with ASP.<br><br /><br /><br><br>Stratum 3: ORR: % of pats with CR, CRi, CRp, measured as best response to InO treatment <br><br /><br /><br>
- Secondary Outcome Measures
Name Time Method In stratum 1A: Safety and tolerability, Measures of anti-leukemic activity, Serum pharmacokinetic parameters of InO and unconjugated calicheamicin, Pharmacodynamic parameters.<br /><br /><br><br>Phase 2 cohort: safety, other measures of anti-leukemic activity, Serum pharmacokinetic parameters of InO and unconjugated calicheamicin, Pharmacodynamic parameters. <br /><br /><br><br>Stratum 2: Measures of anti-tumor activity , Serum pharmacokinetic parameters of InO and unconjugated calicheamicin <br /><br /><br><br>Stratum 1B and 1B-ASP: Safety and tolerability, Measures of anti-leukemic activity, Serum pharmacokinetic parameters of InO and unconjugated calicheamicin, Pharmacodynamic parameters.<br /><br /><br><br>Stratum 3: Safety, other measures of anti-tumor activity, Pharmacodynamic parameters <br /><br /><br>