Clinical trial NCT00458848: Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2007-04-11
Enrollment: 470
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Reaching Disease Free Survival
timeFrame: At 60 months
Secondary outcomes:
measure: Number of Patients Reaching Complete Hematological Response After Induction Therapy
timeFrame: At the end of induction, day +50
measure: Percentage of Participants Reaching Overall Survival
timeFrame: At 60 months
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ospedale Civile Alessandria
city: Ancona
country: Italy
facility: Ospedale Torrette University Ancona
city: Arezzo
country: Italy
facility: Ospedale S. Donato
city: Ascoli Piceno
country: Italy
facility: Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
city: Avellino
country: Italy
facility: S.G. Moscati Hospital
city: Bari
country: Italy
facility: Universita Degli Studi di Bari
city: Bologna
country: Italy
facility: University of Bologna Medical School
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Brindisi
country: Italy
facility: A. Perrino Hospital
city: Cagliari
country: Italy
facility: Ospedale Binaghi
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Catanzaro
country: Italy
facility: Ospedale Regionale A. Pugliese
city: Cosenza
country: Italy
facility: U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
city: Ferrara
country: Italy
facility: Universita di Ferrara
city: Florence
country: Italy
facility: Azienda Ospedaliera di Firenze
city: Foggia
country: Italy
facility: Ospedali Riuniti Foggia
city: Frosinone
country: Italy
facility: Ospedale Umberto I
city: Gallarate
country: Italy
facility: Ospedale S. Antonio Abate
city: Genoa
country: Italy
facility: Ospedale San Martino
city: L'Aquila
country: Italy
facility: Ospedale L'Aquila
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Lecce
country: Italy
facility: Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
city: Lodi
country: Italy
facility: Ospedale Maggiore Lodi
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria - Policlinico G. Martino
city: Milan
country: Italy
facility: Ospedale Niguarda Ca'Granda
city: Modena
country: Italy
facility: Azienda Ospedaliera - Universitaria di Modena
city: Naples
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
city: Naples
country: Italy
facility: Federico II University Medical School
city: Naples
country: Italy
facility: Ospedale S. Gennaro ASL NA1
city: Nocera Inferiore
country: Italy
facility: Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
city: Novara
country: Italy
facility: Amedeo Avogadro University of Eastern Piedmont
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Orbassano
country: Italy
facility: Azienda Ospedale S. Luigi at University of Torino
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Policlinico - Cattedra di Ematologia
city: Palermo
country: Italy
facility: Ospedale Cervello
city: Palermo
country: Italy
facility: Ospedale La Maddalena - Palermo
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. Policlinico San Matteo
city: Pavia
country: Italy
facility: University of Pavia
city: Perugia
country: Italy
facility: Perugia Regional Cancer Center
city: Pesaro
country: Italy
facility: Azienda Ospedale - d S. Salvatore
city: Pescara
country: Italy
facility: Ospedale Civile Pescara
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana
city: Potenza
country: Italy
facility: Azienda Ospedaliera San Carlo - Potenza
city: Ravenna
country: Italy
facility: Ospedale Sta. Maria Delle Croci
city: Ravenna
country: Italy
facility: Ospedale S. M. delle Croci
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi Melacrino Morelli
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: RIONERO in VULTURE
country: Italy
facility: Ospedale Oncologico Regionale
city: Rome
country: Italy
facility: Ospedale Sant' Eugenio
city: Rome
country: Italy
facility: Azienda Ospedaliera S. Camillo-Forlanini
city: Rome
country: Italy
facility: University Campus Bio-Medico
city: Rome
country: Italy
facility: Istituto Regina Elena
city: Rome
country: Italy
facility: Universita Degli Studi "La Sapeinza"
city: Rome
country: Italy
facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
city: Rome
country: Italy
facility: H. San Giovanni-Addolorata Hospital
city: Ronciglione
country: Italy
facility: Ospedale di Ronciglione
city: San Giovanni Rotondo
country: Italy
facility: IRCCS "Casa Sollievo della Sofferenza"
city: Sassari
country: Italy
facility: Istituto di Ematologia Universita - University di Sassari
city: Sondalo
country: Italy
facility: Azienda Ospedale E. Morelli
city: Taormina
country: Italy
facility: Ospedale S. Vincenzo
city: Taranto
country: Italy
facility: Ospedal SS Annunziata
city: Turin
country: Italy
facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
city: Turin
country: Italy
facility: Ospedale Giovanni Bosco
city: Udine
country: Italy
facility: Policlinico Universitario Udine
city: Verona
country: Italy
facility: Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Study officials:
affiliation: Universita Degli Studi "La Sapeinza"
name: Roberto Foa, MD
role: STUDY_CHAIR
References:
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.
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.
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.