Ph+/Bcr-Abl+ ALL Imatinib and Nilotinib Rotational Study (LAL1408)

October 10, 2022 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Front-line Treatment of Ph Positive (Ph+)/Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) With Two Tyrosine Kinase Inhibitors (TKI) (Imatinib and Nilotinib). A Phase II Exploratory Multicentric Study in Elderly Patients and in Patients Unfit for Program of Intensive Therapy and Allogeneic Stem Cell Transplantation. GIMEMA Protocol LAL1408. EudraCT 2009-01327122

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Azienda Ospedaliera - Nuovo Ospedale "Torrette"
      • Ascoli Piceno, Italy, 63100
        • Dipartimento Area Medica P.O.
      • Bari, Italy
        • UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
      • Bergamo, Italy
        • Ospedali Riuniti
      • Bologna, Italy
        • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
      • Brescia, Italy, 21125
        • Sezione di Ematologia e Trapianti Spedali Civili
      • Brindisi, Italy
        • Osp. Reg. A. Di Summa
      • Cagliari, Italy
        • Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi
      • Catania, Italy, 95124
        • Ospedale Ferrarotto
      • Ferrara, Italy, 44100
        • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
      • Genova, Italy
        • Clinica Ematologica - Università degli Studi
      • Milano, Italy, 20122
        • Ospedale Niguarda "Ca' Granda"
      • Modena, Italy
        • Sez. di medicina Interna Oncologia ed Ematologia
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Napoli, Italy
        • Ospedale di Rilievo Nazionale "A. Cardarelli"
      • Novara, Italy
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
      • Orbassano, Italy, 10043
        • Ospedale S. Luigi Gonzaga
      • Padova, Italy
        • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
      • Palermo, Italy
        • Ospedali Riuniti 'Villa Sofia-Cervello'
      • Pavia, Italy, 27100
        • Div. di Ematologia IRCCS Policlinico S. Matteo
      • Pesaro, Italy
        • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
      • Pescara, Italy, 65100
        • U.O. Ematologia Clinica - Azienda USL di Pescara
      • Piacenza, Italy
        • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
      • Ravenna, Italy, 48100
        • Ospedale S.Maria delle Croci
      • Reggio Calabria, Italy
        • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
      • Rimini, Italy
        • Rimini Ospedale "Infermi"
      • Roma, Italy
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Roma, Italy
        • U.O.C. Ematologia - Ospedale S.Eugenio
      • Roma, Italy
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy, 00184
        • Complesso Ospedaliero S. Giovanni Addolorata
      • Roma, Italy, 21100
        • Università degli Studi - Policlinico di Tor Vergata
      • Siena, Italy, 53100
        • U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
      • Torino, Italy
        • SCDO Ematologia 2 AOU S.Giovanni Battista
      • Udine, Italy, 33100
        • Policlinico Universitario - Clinica Ematologia
      • Verona, Italy, 37134
        • Policlinico G.B. Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-Free Survival (DFS)
Time Frame: at 24 months
at 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Michele Baccarani, Policlinico Sant'Orsola

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 3, 2009

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAL1408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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