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

NCT01025505 | Completed Phase 2 DMC

• 1 other identifier: LAL1408
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 35

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

Keywords

Untreated Ph+ ALL unfit for intense therapy and allo SCT

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS)

  at 24 months

Secondary Outcomes (7)

• 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

Interventions

Nilotinib DRUG

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.

Imatinib DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (35)

Azienda Ospedaliera - Nuovo Ospedale "Torrette"

Ancona, Italy

Location

Dipartimento Area Medica P.O.

Ascoli Piceno, 63100, Italy

Location

UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari

Bari, Italy

Location

Ospedali Riuniti

Bergamo, Italy

Location

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

Bologna, Italy

Location

Sezione di Ematologia e Trapianti Spedali Civili

Brescia, 21125, Italy

Location

Osp. Reg. A. Di Summa

Brindisi, Italy

Location

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

Cagliari, Italy

Location

Ospedale Ferrarotto

Catania, 95124, Italy

Location

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

Ferrara, 44100, Italy

Location

Clinica Ematologica - Università degli Studi

Genova, Italy

Location

Ospedale Niguarda "Ca' Granda"

Milan, 20122, Italy

Location

Sez. di medicina Interna Oncologia ed Ematologia

Modena, Italy

Location

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

Napoli, Italy

Location

Ospedale di Rilievo Nazionale "A. Cardarelli"

Napoli, Italy

Location

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

Novara, Italy

Location

Ospedale S. Luigi Gonzaga

Orbassano, 10043, Italy

Location

Università degli Studi di Padova - Ematologia ed Immunologia Clinica

Padua, Italy

Location

Ospedali Riuniti 'Villa Sofia-Cervello'

Palermo, Italy

Location

Div. di Ematologia IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

Location

Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

Pesaro, Italy

Location

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, 65100, Italy

Location

Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

Piacenza, Italy

Location

Ospedale S.Maria delle Croci

Ravenna, 48100, Italy

Location

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

Reggio Calabria, Italy

Location

Rimini Ospedale "Infermi"

Rimini, Italy

Location

Complesso Ospedaliero S. Giovanni Addolorata

Roma, 00184, Italy

Location

Università degli Studi - Policlinico di Tor Vergata

Roma, 21100, Italy

Location

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

Roma, Italy

Location

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, Italy

Location

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

Roma, Italy

Location

U.O. Ematologia, Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

SCDO Ematologia 2 AOU S.Giovanni Battista

Torino, Italy

Location

Policlinico Universitario - Clinica Ematologia

Udine, 33100, Italy

Location

Policlinico G.B. Rossi

Verona, 37134, Italy

Location

Related Links

• GIMEMA Foundation website

MeSH Terms

Interventions

nilotinib; Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Michele Baccarani

  Policlinico Sant'Orsola

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 3, 2009
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2020
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (35)