Acute Lymphoblastic Leukemia (ALL) - Philadelphia Chromosome (Ph)-Negative CD22+ B-cell Precursor (BCP) Clinical Trial
— EWALL-INOOfficial 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
| Verified date | September 2023 |
| Source | Versailles Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 130 |
| Est. completion date | June 2024 |
| Est. primary completion date | May 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Versailles Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Assessment of adverse events (AEs) | Type, duration and frequency of AEs up to 3 months of induction course 1 or 2 | 3 months | |
| Secondary | Rate of complete remission (CR / CRp) | CR/CRp response rate after INO-based induction course 1 and 2 | 35 days | |
| Secondary | Assessment of Minimal residual disease (MRD) | Flow cytometry and Ig-TCR MRD levels, after INO-based induction course 1 and 2 and impact on outcomes | 35 days | |
| Secondary | Rate of early death | Early death (ED) rate at 30, 60 and 100 day from treatment initiation | 100 days | |
| Secondary | Composite measure for Duration of response (DOR), Disease-free survival (DFS) and cumulative incidence of relapse (CIR) | Duration of response (DOR), Disease-free survival (DFS) and cumulative incidence of relapse (CIR) | one year |