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Study of Inotuzumab Ozogamicin Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor ALL
Sponsor: Versailles Hospital
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.
Official 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
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2017-12-28
Completion Date
2024-10-17
Last Updated
2026-06-22
Healthy Volunteers
No
Interventions
Inotuzumab ozogamicin (INO)
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
Locations (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