Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study

Phase 2

Completed

• Conditions: Treatment; Stem Cell Transplantation

• Registration Number: NCT01025505
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary

This study is an open-label, multicentric, exploratory, single arm, phase II study of adults who are either more than 60 years old, or are unfit for intensive chemotherapy and allo SCT. The patients are treated with NILOTINIB, administered orally twice daily, for 6 weeks (Course A) followed by IMATINIB, administered orally twice daily, for other 6 weeks (Course B).The courses will be repeated (rotated) for a total of 4 times or until relapse, or until it is in the interest of the patients. Prednisone (P) will be administered to all patients for 7-14 days, before TKIs, so as to make it possible to wait for the results of cytogenetic and molecular tests, and to evaluate the response to P alone, hence for another 21 days. Intrathecal therapy (IT) with MTX/AraC/DEX is mandatory, monthly, in patients without clinical-cytologic evidence of meningeal involvement, while in patients with CNS involvement it is performed twice weekly until clearance of leukemic cells, hence once weekly. IM will be administered at the dosage of 600 mg daily (300 mg twice daily) and Nilotinib at the dosage of 800 mg daily (400 mg twice daily) in all courses.

All patients are scheduled to receive at least 4 courses of either drugs, for a total of 4 courses (4 x 6 = 24 weeks). After 4 courses, patients are either allowed to continue the treatment until relapse or progression, if it is in their interest, or to discontinue the treatment and receive other therapies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Study Start: 2012-06
• Primary Completion: 2015-12
• Study Completion: 2020-09-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Previously untreated Ph+ ALL more than 60 years old or more than 18 years old, but unfit for program of intensive therapy and allogeneic SCT

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (DFS)	at 24 months

Secondary Outcome Measures

Name	Time	Method
Complete Hematological Response (CHR) rate	at 6, 12 and 24 weeks
Complete Cytogenetic Response (CCgR) rate	at 6, 12 and 24 weeks and duration of CCgR
Complete molecular response rate (CMR)	at 12 and 24 weeks and duration of CMolR
Type and number of BCR-ABL kinase domain mutations	developing during and after the study
Relationship between the response, biomarkers and gene expression profile (GEP)	At the end of study
Event-Free Survival (EFS) and Overall Survival (OS)	defined as the time from the 1st dose of corticosteroids to death or last contact
Side effects, adverse events (AE) and serious AE (SAE)	At the end of study

Trial Locations

Locations (35)

Osp. Reg. A. Di Summa; 🇮🇹 Brindisi, Italy

Clinica Ematologica - Università degli Studi; 🇮🇹 Genova, Italy

U.O. Ematologia, Azienda Ospedaliera Universitaria Senese; 🇮🇹 Siena, Italy

Complesso Ospedaliero S. Giovanni Addolorata; 🇮🇹 Roma, Italy

Policlinico Universitario - Clinica Ematologia; 🇮🇹 Udine, Italy

Dipartimento Area Medica P.O.; 🇮🇹 Ascoli Piceno, Italy

UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari; 🇮🇹 Bari, Italy

Ist.Ematologia e Oncologia Medica L.e A. Seragnoli; 🇮🇹 Bologna, Italy

Azienda Ospedaliera - Nuovo Ospedale "Torrette"; 🇮🇹 Ancona, Italy

Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Div. di Ematologia IRCCS Policlinico S. Matteo; 🇮🇹 Pavia, Italy

Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore; 🇮🇹 Pesaro, Italy

Sez. di medicina Interna Oncologia ed Ematologia; 🇮🇹 Modena, Italy

Ospedale di Rilievo Nazionale "A. Cardarelli"; 🇮🇹 Napoli, Italy

Ospedale S. Luigi Gonzaga; 🇮🇹 Orbassano, Italy

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia; 🇮🇹 Roma, Italy

Rimini Ospedale "Infermi"; 🇮🇹 Rimini, Italy

Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"; 🇮🇹 Reggio Calabria, Italy

Policlinico G.B. Rossi; 🇮🇹 Verona, Italy

U.O.C. Ematologia - Ospedale S.Eugenio; 🇮🇹 Roma, Italy

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli; 🇮🇹 Roma, Italy

SCDO Ematologia 2 AOU S.Giovanni Battista; 🇮🇹 Torino, Italy

Sezione di Ematologia e Trapianti Spedali Civili; 🇮🇹 Brescia, Italy

Ospedale Ferrarotto; 🇮🇹 Catania, Italy

Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna; 🇮🇹 Ferrara, Italy

Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi; 🇮🇹 Cagliari, Italy

Ospedale Niguarda "Ca' Granda"; 🇮🇹 Milano, Italy

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia; 🇮🇹 Napoli, Italy

U.O. Ematologia Clinica - Azienda USL di Pescara; 🇮🇹 Pescara, Italy

Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza; 🇮🇹 Piacenza, Italy

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro; 🇮🇹 Novara, Italy

Università degli Studi di Padova - Ematologia ed Immunologia Clinica; 🇮🇹 Padova, Italy

Ospedali Riuniti 'Villa Sofia-Cervello'; 🇮🇹 Palermo, Italy

Ospedale S.Maria delle Croci; 🇮🇹 Ravenna, Italy

Università degli Studi - Policlinico di Tor Vergata; 🇮🇹 Roma, Italy