A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients with Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia
- Conditions
- 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: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004942-27-FI
- Lead Sponsor
- Centre Hospitalier de Versailles
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 130
- 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.
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
- 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 maintenance.
- 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 and for
3 month following the last dose of maintenance.
- Any of concurrent severe and/or uncontrolled medical condition, which
could compromise participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method