Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia (LAL0904)

September 24, 2018 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Study Overview

Status

Completed

Conditions

Leukemia

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

470

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
- - Alessandria, Italy, I-15100
    - Ospedale Civile Alessandria
  - Ancona, Italy, 60020
    - Ospedale Torrette University Ancona
  - Arezzo, Italy, 52100
    - Ospedale S. Donato
  - Ascoli Piceno, Italy
    - Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
  - Avellino, Italy, 83100
    - S.G. Moscati Hospital
  - Bari, Italy, 70124
    - Università degli Studi di Bari
  - Bologna, Italy, 40138
    - University of Bologna Medical School
  - Brescia, Italy, 25123
    - Spedali Civili di Brescia
  - Brindisi, Italy, 72100
    - A. Perrino Hospital
  - Cagliari, Italy, 090100
    - Ospedale Binaghi
  - Catania, Italy, 95124
    - Ospedale Ferrarotto
  - Catanzaro, Italy, 88100
    - Ospedale Regionale A. Pugliese
  - Cosenza, Italy
    - U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
  - Ferrara, Italy, 44100
    - Università di Ferrara
  - Florence, Italy, 50011
    - Azienda Ospedaliera di Firenze
  - Foggia, Italy, 71100
    - Ospedali Riuniti Foggia
  - Frosinone, Italy, 03100
    - Ospedale Umberto I
  - Gallarate, Italy, 21013
    - Ospedale S. Antonio Abate
  - Genoa, Italy, 16132
    - Ospedale San Martino
  - L'Aquila, Italy, 67100
    - Ospedale L'Aquila
  - Latina, Italy, 04100
    - Ospedale Santa Maria Goretti
  - Lecce, Italy
    - Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
  - Lodi, Italy, I-20075
    - Ospedale Maggiore Lodi
  - Messina, Italy, 98125
    - Azienda Ospedaliera Universitaria - Policlinico G. Martino
  - Milan, Italy, 20162
    - Ospedale Niguarda Ca'Granda
  - Modena, Italy, 41100
    - Azienda Ospedaliera - Universitaria di Modena
  - Naples, Italy, 80131
    - Federico II University Medical School
  - Naples, Italy, 80127
    - Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
  - Naples, Italy, 80131
    - Ospedale S. Gennaro ASL NA1
  - Nocera Inferiore, Italy
    - Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
  - Novara, Italy, I-28100
    - Amedeo Avogadro University of Eastern Piedmont
  - Nuoro, Italy, 08100
    - Ospedale San Francesco
  - Orbassano, Italy, 10043
    - Azienda Ospedale S. Luigi at University of Torino
  - Padova, Italy, 35128
    - Azienda Ospedaliera di Padova
  - Palermo, Italy, 90146
    - Ospedale Cervello
  - Palermo, Italy
    - Ospedale La Maddalena - Palermo
  - Palermo, Italy, 90100
    - Policlinico - Cattedra di Ematologia
  - Pavia, Italy, 27100
    - University of Pavia
  - Pavia, Italy, 27100
    - Fondazione I.R.C.C.S. Policlinico San Matteo
  - Perugia, Italy, 06122
    - Perugia Regional Cancer Center
  - Pesaro, Italy, 61100
    - Azienda Ospedale - d S. Salvatore
  - Pescara, Italy, 65100
    - Ospedale Civile Pescara
  - Pisa, Italy
    - Azienda Ospedaliera Pisana
  - Potenza, Italy, 85100
    - Azienda Ospedaliera San Carlo - Potenza
  - RIONERO in VULTURE, Italy, I-58028
    - Ospedale Oncologico Regionale
  - Ravenna, Italy, 48100
    - Ospedale Sta. Maria Delle Croci
  - Ravenna, Italy, I-48100
    - Ospedale S. M. delle Croci
  - Reggio Calabria, Italy, 89100
    - Azienda Ospedaliera Bianchi Melacrino Morelli
  - Reggio Emilia, Italy, 42100
    - Arcispedale S. Maria Nuova
  - Rome, Italy, 00161
    - Istituto Regina Elena
  - Rome, Italy, 00144
    - Ospedale Sant' Eugenio
  - Rome, Italy, 00161
    - Universita Degli Studi "La Sapeinza"
  - Rome, Italy, 00168
    - Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  - Rome, Italy, 00151
    - Azienda Ospedaliera S. Camillo-Forlanini
  - Rome, Italy, 00155
    - University Campus Bio-Medico
  - Rome, Italy, 00184
    - H. San Giovanni-Addolorata Hospital
  - Ronciglione, Italy, 01037
    - Ospedale di Ronciglione
  - San Giovanni Rotondo, Italy, 71013
    - IRCCS "Casa Sollievo della Sofferenza"
  - Sassari, Italy, 07100
    - Istituto di Ematologia Universita - University di Sassari
  - Sondalo, Italy, 23039
    - Azienda Ospedale E. Morelli
  - Taormina, Italy, 98039
    - Ospedale S. Vincenzo
  - Taranto, Italy, 74100
    - Ospedal SS Annunziata
  - Turin, Italy, 10126
    - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  - Turin, Italy
    - Ospedale Giovanni Bosco
  - Udine, Italy, 33100
    - Policlinico Universitario Udine
  - Verona, Italy
    - Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - 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

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:
- Negative myeloperoxidase stain
- Phenotype T (T-ALL) or B (B-ALL)
- No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)

PATIENT CHARACTERISTICS:

Creatinine ≤ 2.5 mg/dL (after adequate hydration)
SGOT and SGPT ≤ 3 times upper limit of normal
LVEF ≥ 50%
No severe psychiatric disorders
No other concurrent malignant disease
No presence of documented infections not responding to antibiotic and/or antifungal therapy
Not pregnant

PRIOR CONCURRENT THERAPY:

No prior steroids
No prior antiblastic chemotherapy
No other concurrent chemotherapy or radiotherapy

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
Percentage of Participants Reaching Disease Free Survival Time Frame: At 60 months	At 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Reaching Complete Hematological Response After Induction Therapy Time Frame: At the end of induction, day +50		At the end of induction, day +50
Percentage of Participants Reaching Overall Survival Time Frame: At 60 months	Overall survival from diagnosis	At 60 months

Collaborators and Investigators

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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Study Chair: Roberto Foa, MD, Universita Degli Studi "La Sapeinza"

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.

General Publications

Helpful Links

GIMEMA Foundation website

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

October 1, 2004

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 9, 2007

First Submitted That Met QC Criteria