Philadelphia chromosome (Ph)-negative CD22+ B-cell Precursor (BCP) Acute Lymphoblastic Leukemia (ALL) MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000012958
Conditions
Interventions
Product Name: inotuzumab ozogamicin
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: INOTUZUMAB OZOGAMICIN
CAS Number: 635715-01-4
Current Sponsor code: WS2118883
Other
Sponsors
Centre Hospitalier de Versailles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged more than 55 years old, - With confirmed diagnosis of BCP-ALL according to WHO criteria expressing the CD22 antigen by flow cytometry (20% or more positive blast cells), - Without central nervous system (CNS) involvement, - Without BCR-ABL fusion by standard cytogenetics, FISH analysis and/or RT-PCR, - Previously untreated, - Eligible to intensive chemotherapy, due to general health status, - ECOG performance status = 2, - Patients must have the following laboratory values unless considered due to leukemia: AST and ALT = 2.5 x upper the limit of normal (ULN); estimated GFR = 50 mL/min using the MDRD equation; total and direct serum bilirubin = 1.5 x ULN; electrolyte panel within normal ranges for the institution unless attributed to the underlying disease. - Written informed consent obtained prior to any screening procedures. - Eligible for National Health Insurance in France. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: - Concurrent therapy with any other investigational agent or cytotoxic drug, - Prior documented chronic liver disease, - Active HBV or HCV hepatitis or positive HIV serology, - Female patients who are pregnant or breast feeding or patients of childbearing potential not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug. - Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study, - Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess overall survival (OS) observed at 1 year after administration of INO and chemotherapy in older Ph-negative BCP-ALL patients. ;Secondary Objective: - Overall survival after censoring patients who will receive subsequent anti-leukemic treatment (for instance, allogeneic SCT or blinatumomab) at the start of this subsequent treatment; - Type, duration and frequency of AEs up to 3 months of induction course 1 or 2; - CR/CRp response rate after INO-based induction course 1 and 2; - Flow cytometry and Ig-TCR MRD levels, after INO-based induction course 1 and 2 and impact on outcomes; - Centralized ALL genomic characterization; - Early death (ED) rate at 30, 60 and 100 day from treatment initiation; Duration of response (DOR), disease-free survival (DFS) and cumulative incidence of relapse (CIR). ;Primary end point(s): Overall survival, defined by the time between day+1 of induction therapy until date of death or last follow-up, will be assessed by the 1-year Kaplan-Meier estimate.;Timepoint(s) of evaluation of this end point: The time frame between day+1 of induction therapy until date of death or last follow-up (one year maximum). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - DFS is defined in responding patients (CR/CRp) by the time between the day of CR/CRp documentation until date of relapse, death or last follow-up. - DOR is defined by the time between the day of CR/CRp documentation until relapse, or last follow-up. - CIR is defined by the time between the day of CR/CRp documentation until relapse, or last follow-up considering deaths in first CR/CRp as competing events.;Timepoint(s) of evaluation of this end point: The time frame between the day of CR/CRp documentation until date of relapse, death or last follow-up. | — |
Countries
Finland, France
Contacts
Public ContactAssitan KONE
Centre Hospitalier de Versailles
Outcome results
None listed