Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00458848
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of Participants Reaching Disease Free Survival At 60 months
- Secondary Outcome Measures
Name Time Method Number of Patients Reaching Complete Hematological Response After Induction Therapy At the end of induction, day +50 Percentage of Participants Reaching Overall Survival At 60 months Overall survival from diagnosis
Trial Locations
- Locations (66)
Ospedale S. Donato
🇮🇹Arezzo, Italy
S.G. Moscati Hospital
🇮🇹Avellino, Italy
Ospedale Binaghi
🇮🇹Cagliari, Italy
Ospedale Ferrarotto
🇮🇹Catania, Italy
Ospedali Riuniti Foggia
🇮🇹Foggia, Italy
Ospedale San Martino
🇮🇹Genoa, Italy
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Ospedale Santa Maria Goretti
🇮🇹Latina, Italy
Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
🇮🇹Lecce, Italy
Ospedale Niguarda Ca'Granda
🇮🇹Milan, Italy
Federico II University Medical School
🇮🇹Naples, Italy
U.O. Ematologia - P.O. Annunziata - A.O. di Cosenza
🇮🇹Cosenza, Italy
Ospedale Umberto I
🇮🇹Frosinone, Italy
Ospedale Cervello
🇮🇹Palermo, Italy
Ospedale Civile Pescara
🇮🇹Pescara, Italy
A. Perrino Hospital
🇮🇹Brindisi, Italy
Ospedale Regionale A. Pugliese
🇮🇹Catanzaro, Italy
Universita di Ferrara
🇮🇹Ferrara, Italy
Ospedale L'Aquila
🇮🇹L'Aquila, Italy
Azienda Ospedaliera - Universitaria di Modena
🇮🇹Modena, Italy
Azienda Ospedale S. Luigi at University of Torino
🇮🇹Orbassano, Italy
Azienda Ospedaliera Universitaria - Policlinico G. Martino
🇮🇹Messina, Italy
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
🇮🇹Nocera Inferiore, Italy
Amedeo Avogadro University of Eastern Piedmont
🇮🇹Novara, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Azienda Ospedaliera San Carlo - Potenza
🇮🇹Potenza, Italy
Ospedale Sta. Maria Delle Croci
🇮🇹Ravenna, Italy
Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
IRCCS "Casa Sollievo della Sofferenza"
🇮🇹San Giovanni Rotondo, Italy
Ospedal SS Annunziata
🇮🇹Taranto, Italy
Ospedale di Ronciglione
🇮🇹Ronciglione, Italy
Istituto di Ematologia Universita - University di Sassari
🇮🇹Sassari, Italy
Ospedale Giovanni Bosco
🇮🇹Turin, Italy
Ospedale S. Vincenzo
🇮🇹Taormina, Italy
University Campus Bio-Medico
🇮🇹Rome, Italy
Azienda Ospedale E. Morelli
🇮🇹Sondalo, Italy
Policlinico Universitario Udine
🇮🇹Udine, Italy
Ospedale Torrette University Ancona
🇮🇹Ancona, Italy
Ospedale Maggiore Lodi
🇮🇹Lodi, Italy
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
🇮🇹Naples, Italy
Ospedale San Francesco
🇮🇹Nuoro, Italy
Policlinico - Cattedra di Ematologia
🇮🇹Palermo, Italy
Ospedale La Maddalena - Palermo
🇮🇹Palermo, Italy
University of Pavia
🇮🇹Pavia, Italy
Azienda Ospedale - d S. Salvatore
🇮🇹Pesaro, Italy
Azienda Ospedaliera Pisana
🇮🇹Pisa, Italy
Ospedale Civile Alessandria
🇮🇹Alessandria, Italy
Universita Degli Studi di Bari
🇮🇹Bari, Italy
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
🇮🇹Ascoli Piceno, Italy
University of Bologna Medical School
🇮🇹Bologna, Italy
Ospedale S. Antonio Abate
🇮🇹Gallarate, Italy
Azienda Ospedaliera di Firenze
🇮🇹Florence, Italy
Ospedale S. Gennaro ASL NA1
🇮🇹Naples, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
Perugia Regional Cancer Center
🇮🇹Perugia, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy
Ospedale Sant' Eugenio
🇮🇹Rome, Italy
Ospedale S. M. delle Croci
🇮🇹Ravenna, Italy
Ospedale Oncologico Regionale
🇮🇹RIONERO in VULTURE, Italy
Azienda Ospedaliera S. Camillo-Forlanini
🇮🇹Rome, Italy
Istituto Regina Elena
🇮🇹Rome, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
H. San Giovanni-Addolorata Hospital
🇮🇹Rome, Italy
Universita Degli Studi "La Sapeinza"
🇮🇹Rome, Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
🇮🇹Turin, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
🇮🇹Verona, Italy