Study of Inotuzumab Ozogamicin Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor ALL
EWALL-INO
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
2 other identifiers
interventional
130
1 country
41
Brief Summary
The aim of the present EWALL-INO study is to confirm very promising results obtained with a combination of INO and mild chemotherapy in older de novo CD22+ B-ALL patients. For that purpose, safety and efficacy of a weekly INO administration combined to mild-intensity chemotherapy will be evaluated in a cohort of patients aged more than 55 years with newly diagnosed previously untreated Ph-negative (CD22+) BCP-ALL. Conversely to the MDACC miniHCVD-INO study and in order to lower the overall toxicity of the combination, INO will be given as part of the remission induction treatment phase during the first 2 treatment cycles only, in combination with corticosteroid, vincristine, cyclophosphamide and intrathecal prophylaxis only; then, all responding patients will received standard INO-free chemotherapy as consolidation and maintenance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2017
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2017
CompletedFirst Posted
Study publicly available on registry
August 15, 2017
CompletedStudy Start
First participant enrolled
December 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedSeptember 6, 2023
September 1, 2023
5.4 years
August 10, 2017
September 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Assessment of overall survival (OS)
The primary objective of the trial is to assess overall survival (OS) observed at 1 year after administration of INO and chemotherapy in older Ph-negative BCP-ALL patients.
one year
Secondary Outcomes (5)
Assessment of adverse events (AEs)
3 months
Rate of complete remission (CR / CRp)
35 days
Assessment of Minimal residual disease (MRD)
35 days
Rate of early death
100 days
Composite measure for Duration of response (DOR), Disease-free survival (DFS) and cumulative incidence of relapse (CIR)
one year
Study Arms (1)
Inotuzumab ozogamicin (INO)
EXPERIMENTALInterventions
INO schedule of administration is as follows: * First induction course: 0.8 mg/m² on day 1, 0.5 mg/m² on day 8, and 0.5 mg/m² on day 15 * Second induction course: 0.5 mg/m² on day 1, and 0.5 mg/m² on day 8
Eligibility Criteria
You may qualify if:
- Patients aged more than 55 years old,
- With confirmed diagnosis of BCP-ALL according to World Health Organisation (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, Fluorescence In Situ Hybridization (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.
You may not qualify if:
- Concurrent therapy with any other investigational agent or cytotoxic drug,
- Prior documented chronic liver disease,
- Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) 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 months following the last dose of maintenance.
- Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
CH Amiens sud
Amiens, France
CHU Angers
Angers, France
CH Victor Dupouy
Argenteuil, France
CH cote basque
Bayonne, France
CHU Besançon
Besançon, France
Hopital Avicenne
Bobigny, France
Hopital Duchenne
Boulogne-sur-Mer, France
CHU Caen
Caen, France
CH Rene Dubois
Cergy-Pontoise, France
CH metropole Savoie_ chambery
Chambéry, France
HIA Percy
Clamart, France
CHU Clermond Ferrand
Clermont-Ferrand, France
Hopital Mondor
Créteil, France
Hopital Dijon
Dijon, France
CHU Grenoble
Grenoble, France
CHU la Reunion
La Réunion, France
CH Versailles
Le Chesnay, France
CHU Limoges
Limoges, France
Centre Leon Berard
Lyon, France
IPC
Marseille, France
CH Meaux
Meaux, France
CH Montpellier
Montpellier, France
CHU Nantes
Nantes, France
Centre Lacassagne
Nice, France
CHU Nice
Nice, France
CHU Nimes
Nîmes, France
CHR Orléans
Orléans, France
Hopital Necker
Paris, France
Hopital St Antoine
Paris, France
Hopital St Louis
Paris, France
CHU Haut Leveque
Pessac, France
CH Lyon Sud
Pierre-Bénite, France
CH Reims
Reims, France
CHU Pontchaillou
Rennes, France
CH Roubaix
Roubaix, France
Centre H Becquerel Rouen
Rouen, France
Institut de cancerologie
Saint-Priest-en-Jarez, France
CHU Strasbourg
Strasbourg, France
IUCT Oncopole
Toulouse, France
CH Valenciennes
Valenciennes, France
CHRU Nancy
Vandœuvre-lès-Nancy, France
Related Publications (1)
Chevallier P, Leguay T, Delord M, Salek C, Kim R, Huguet F, Hicheri Y, Wartiovaara-Kautto U, Raffoux E, Cluzeau T, Balsat M, Roth-Guepin G, Tavernier E, Lepretre S, Bilger K, Bergugnat H, Berceanu A, Alexis M, Doubek M, Brissot E, Hunault-Berger M, Lebon D, Turlure P, Chantepie S, Belhabri A, Wickenhauser S, Bastie JN, Cacheux V, Himberlin C, Banos A, Gardin C, Bonnet S, Plantier I, Pica GM, Escoffre-Barbe M, Boissel N, Dombret H, Clappier E, Rousselot P; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) and the European Working Group for Adult Acute Lymphoblastic Leukemia (EWALL); European Working Group for Adult Acute Lymphoblastic Leukemia (EWALL). Inotuzumab Ozogamicin and Low-Intensity Chemotherapy in Older Patients With Newly Diagnosed CD22+ Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia. J Clin Oncol. 2024 Dec 20;42(36):4327-4341. doi: 10.1200/JCO.24.00490. Epub 2024 Oct 17.
PMID: 39418626DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrice CHEVALLIER, MD
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 10, 2017
First Posted
August 15, 2017
Study Start
December 28, 2017
Primary Completion
May 30, 2023
Study Completion
June 1, 2024
Last Updated
September 6, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share