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

NCT ID: NCT01025505

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2020-09-01

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.

Conditions

Treatment; Stem Cell Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Nilotinib

The dose of NIL is 800 mg daily (400 mg twice daily). It must be adapted according to specific guidelines in case of adverse events (AE). It cannot be increased.

Intervention Type: DRUG

Imatinib

The dose of IM is 600 mg daily (300 mg b.i.d.). It must be adapted according to specific guidelines in case of AE. It cannot be increased.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Baccarani

Role: PRINCIPAL_INVESTIGATOR

Policlinico Sant'Orsola

Locations

Azienda Ospedaliera - Nuovo Ospedale "Torrette"

Ancona, , Italy

Dipartimento Area Medica P.O.

Ascoli Piceno, , Italy

UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari

Bari, , Italy

Ospedali Riuniti

Bergamo, , Italy

Ist.Ematologia e Oncologia Medica L.e A. Seragnoli

Bologna, , Italy

Sezione di Ematologia e Trapianti Spedali Civili

Brescia, , Italy

Osp. Reg. A. Di Summa

Brindisi, , Italy

Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi

Cagliari, , Italy

Ospedale Ferrarotto

Catania, , Italy

Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna

Ferrara, , Italy

Clinica Ematologica - Università degli Studi

Genova, , Italy

Ospedale Niguarda "Ca' Granda"

Milan, , Italy

Sez. di medicina Interna Oncologia ed Ematologia

Modena, , Italy

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, , Italy

Ospedale di Rilievo Nazionale "A. Cardarelli"

Napoli, , Italy

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, , Italy

Ospedale S. Luigi Gonzaga

Orbassano, , Italy

Università degli Studi di Padova - Ematologia ed Immunologia Clinica

Padua, , Italy

Ospedali Riuniti 'Villa Sofia-Cervello'

Palermo, , Italy

Div. di Ematologia IRCCS Policlinico S. Matteo

Pavia, , Italy

Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

Pesaro, , 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

Ospedale S.Maria delle Croci

Ravenna, , Italy

Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

Reggio Calabria, , Italy

Rimini Ospedale "Infermi"

Rimini, , Italy

Complesso Ospedaliero S. Giovanni Addolorata

Roma, , Italy

Università degli Studi - Policlinico di Tor Vergata

Roma, , Italy

U.O.C. Ematologia - Ospedale S.Eugenio

Roma, , Italy

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, , Italy

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

Roma, , Italy

U.O. Ematologia, Azienda Ospedaliera Universitaria Senese

Siena, , Italy

SCDO Ematologia 2 AOU S.Giovanni Battista

Torino, , Italy

Policlinico Universitario - Clinica Ematologia

Udine, , Italy

Policlinico G.B. Rossi

Verona, , Italy

Countries

Italy

Related Links

http://www.gimema.it

GIMEMA Foundation website

Other Identifiers

LAL1408

Identifier Type: -

Identifier Source: org_study_id