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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
asparaginase
daunorubicin hydrochloride
etoposide
idarubicin
imatinib mesylate
mercaptopurine
methotrexate
methylprednisolone
mitoxantrone hydrochloride
prednisone
vincristine sulfate
allogeneic hematopoietic stem cell transplantation
autologous hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring B-cell adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, TdT positive adult acute lymphoblastic leukemia

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Civile Alessandria
  • Ospedale Torrette University Ancona
  • Ospedale S. Donato
  • Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
  • S.G. Moscati Hospital
  • Universita Degli Studi di Bari
  • University of Bologna Medical School
  • Spedali Civili di Brescia
  • A. Perrino Hospital
  • Ospedale Binaghi
  • Ospedale Ferrarotto
  • Ospedale Regionale A. Pugliese
  • U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
  • Universita di Ferrara
  • Azienda Ospedaliera di Firenze
  • Ospedali Riuniti Foggia
  • Ospedale Umberto I
  • Ospedale S. Antonio Abate
  • Ospedale San Martino
  • Ospedale L'Aquila
  • Ospedale Santa Maria Goretti
  • Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
  • Ospedale Maggiore Lodi
  • Azienda Ospedaliera Universitaria - Policlinico G. Martino
  • Ospedale Niguarda Ca'Granda
  • Azienda Ospedaliera - Universitaria di Modena
  • Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
  • Federico II University Medical School
  • Ospedale S. Gennaro ASL NA1
  • Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
  • Amedeo Avogadro University of Eastern Piedmont
  • Ospedale San Francesco
  • Azienda Ospedale S. Luigi at University of Torino
  • Azienda Ospedaliera di Padova
  • Policlinico - Cattedra di Ematologia
  • Ospedale Cervello
  • Ospedale La Maddalena - Palermo
  • Fondazione I.R.C.C.S. Policlinico San Matteo
  • University of Pavia
  • Perugia Regional Cancer Center
  • Azienda Ospedale - d S. Salvatore
  • Ospedale Civile Pescara
  • Azienda Ospedaliera Pisana
  • Azienda Ospedaliera San Carlo - Potenza
  • Ospedale Sta. Maria Delle Croci
  • Ospedale S. M. delle Croci
  • Azienda Ospedaliera Bianchi Melacrino Morelli
  • Arcispedale S. Maria Nuova
  • Ospedale Oncologico Regionale
  • Ospedale Sant' Eugenio
  • Azienda Ospedaliera S. Camillo-Forlanini
  • University Campus Bio-Medico
  • Istituto Regina Elena
  • Universita Degli Studi "La Sapeinza"
  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  • H. San Giovanni-Addolorata Hospital
  • Ospedale di Ronciglione
  • IRCCS "Casa Sollievo della Sofferenza"
  • Istituto di Ematologia Universita - University di Sassari
  • Azienda Ospedale E. Morelli
  • Ospedale S. Vincenzo
  • Ospedal SS Annunziata
  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  • Ospedale Giovanni Bosco
  • Policlinico Universitario Udine
  • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Outcomes

Primary Outcome Measures

Percentage of Participants Reaching Disease Free Survival

Secondary Outcome Measures

Number of Patients Reaching Complete Hematological Response After Induction Therapy
Percentage of Participants Reaching Overall Survival
Overall survival from diagnosis

Full Information

First Posted
April 9, 2007
Last Updated
September 24, 2018
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT00458848
Brief Title
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
Acronym
LAL0904
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
B-cell adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, L1 adult acute lymphoblastic leukemia, L2 adult acute lymphoblastic leukemia, TdT positive adult acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
470 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
asparaginase
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Type
Drug
Intervention Name(s)
mercaptopurine
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
allogeneic hematopoietic stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
autologous hematopoietic stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Percentage of Participants Reaching Disease Free Survival
Time Frame
At 60 months
Secondary Outcome Measure Information:
Title
Number of Patients Reaching Complete Hematological Response After Induction Therapy
Time Frame
At the end of induction, day +50
Title
Percentage of Participants Reaching Overall Survival
Description
Overall survival from diagnosis
Time Frame
At 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Foa, MD
Organizational Affiliation
Universita Degli Studi "La Sapeinza"
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Civile Alessandria
City
Alessandria
ZIP/Postal Code
I-15100
Country
Italy
Facility Name
Ospedale Torrette University Ancona
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Ospedale S. Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
City
Ascoli Piceno
Country
Italy
Facility Name
S.G. Moscati Hospital
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Universita Degli Studi di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
University of Bologna Medical School
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A. Perrino Hospital
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Facility Name
Ospedale Binaghi
City
Cagliari
ZIP/Postal Code
090100
Country
Italy
Facility Name
Ospedale Ferrarotto
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Ospedale Regionale A. Pugliese
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
City
Cosenza
Country
Italy
Facility Name
Universita di Ferrara
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Azienda Ospedaliera di Firenze
City
Florence
ZIP/Postal Code
50011
Country
Italy
Facility Name
Ospedali Riuniti Foggia
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Ospedale Umberto I
City
Frosinone
ZIP/Postal Code
03100
Country
Italy
Facility Name
Ospedale S. Antonio Abate
City
Gallarate
ZIP/Postal Code
21013
Country
Italy
Facility Name
Ospedale San Martino
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale L'Aquila
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Ospedale Santa Maria Goretti
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
City
Lecce
Country
Italy
Facility Name
Ospedale Maggiore Lodi
City
Lodi
ZIP/Postal Code
I-20075
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Policlinico G. Martino
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Ospedale Niguarda Ca'Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
City
Naples
ZIP/Postal Code
80127
Country
Italy
Facility Name
Federico II University Medical School
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S. Gennaro ASL NA1
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
City
Nocera Inferiore
Country
Italy
Facility Name
Amedeo Avogadro University of Eastern Piedmont
City
Novara
ZIP/Postal Code
I-28100
Country
Italy
Facility Name
Ospedale San Francesco
City
Nuoro
ZIP/Postal Code
08100
Country
Italy
Facility Name
Azienda Ospedale S. Luigi at University of Torino
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico - Cattedra di Ematologia
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Ospedale Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Ospedale La Maddalena - Palermo
City
Palermo
Country
Italy
Facility Name
Fondazione I.R.C.C.S. Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
University of Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Perugia Regional Cancer Center
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Azienda Ospedale - d S. Salvatore
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Ospedale Civile Pescara
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Facility Name
Azienda Ospedaliera Pisana
City
Pisa
Country
Italy
Facility Name
Azienda Ospedaliera San Carlo - Potenza
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale Sta. Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Ospedale S. M. delle Croci
City
Ravenna
ZIP/Postal Code
I-48100
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi Melacrino Morelli
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Ospedale Oncologico Regionale
City
RIONERO in VULTURE
ZIP/Postal Code
I-58028
Country
Italy
Facility Name
Ospedale Sant' Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera S. Camillo-Forlanini
City
Rome
ZIP/Postal Code
00151
Country
Italy
Facility Name
University Campus Bio-Medico
City
Rome
ZIP/Postal Code
00155
Country
Italy
Facility Name
Istituto Regina Elena
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Universita Degli Studi "La Sapeinza"
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
H. San Giovanni-Addolorata Hospital
City
Rome
ZIP/Postal Code
00184
Country
Italy
Facility Name
Ospedale di Ronciglione
City
Ronciglione
ZIP/Postal Code
01037
Country
Italy
Facility Name
IRCCS "Casa Sollievo della Sofferenza"
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto di Ematologia Universita - University di Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Azienda Ospedale E. Morelli
City
Sondalo
ZIP/Postal Code
23039
Country
Italy
Facility Name
Ospedale S. Vincenzo
City
Taormina
ZIP/Postal Code
98039
Country
Italy
Facility Name
Ospedal SS Annunziata
City
Taranto
ZIP/Postal Code
74100
Country
Italy
Facility Name
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Giovanni Bosco
City
Turin
Country
Italy
Facility Name
Policlinico Universitario Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
City
Verona
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27515250
Citation
Chiaretti S, Vitale A, Vignetti M, Piciocchi A, Fazi P, Elia L, Falini B, Ronco F, Ferrara F, De Fabritiis P, Luppi M, La Nasa G, Tedeschi A, Califano C, Fanin R, Dore F, Mandelli F, Meloni G, Foa R. A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: final results of the GIMEMA LAL 0904 study. Haematologica. 2016 Dec;101(12):1544-1552. doi: 10.3324/haematol.2016.144535. Epub 2016 Aug 11.
Results Reference
background
PubMed Identifier
21623761
Citation
Messina M, Chiaretti S, Iacobucci I, Tavolaro S, Lonetti A, Santangelo S, Elia L, Papayannidis C, Paoloni F, Vitale A, Guarini A, Martinelli G, Foa R. AICDA expression in BCR/ABL1-positive acute lymphoblastic leukaemia is associated with a peculiar gene expression profile. Br J Haematol. 2011 Mar;152(6):727-32. doi: 10.1111/j.1365-2141.2010.08449.x. Epub 2011 Jan 31.
Results Reference
result
PubMed Identifier
34048072
Citation
Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
Results Reference
derived
Links:
URL
http://www.gimema.it
Description
GIMEMA Foundation Website

Learn more about this trial

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

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