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COMPLETED
NCT03249870
PHASE2

Study of Inotuzumab Ozogamicin Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor ALL

Sponsor: Versailles Hospital

View on ClinicalTrials.gov

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

DRUG

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