Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients with Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2016-004942-27-FR
• Date of registration: 21/07/2017
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier de Versailles
• Public title: Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients with Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia
• Scientific title: 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 - EWALL INO
• Date of first enrolment: 17/07/2017
• Target sample size: 130
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004942-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

France

Contacts

• Name: Assitan KONE
• Affiliation: Centre Hospitalier de Versailles

• Name: Assitan KONE
• Affiliation: Centre Hospitalier de Versailles

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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 descriptive name: INOTUZUMAB OZOGAMICIN
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: range
Concentration number: 0.8-0.5

Trade Name: Oncovin
Pharmaceutical Form: Powder for solution for injection

Trade Name: Methotrexate Accord
Pharmaceutical Form: Powder for solution for injection

Trade Name: Endoxan
Pharmaceutical Form: Powder for solution for infusion

Primary Outcome(s)

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 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).

Main Objective: Assess overall survival (OS) observed at 1 year after administration of INO and chemotherapy in older Ph-negative BCP-ALL patients.

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.

Secondary Outcome(s)

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.

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.

Secondary ID(s)

P16/11

Source(s) of Monetary Support

Pfizer