Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT01156883
- 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. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.
- Detailed Description
OBJECTIVES:
* To determine the feasibility of combination chemotherapy in young adult patients with acute lymphoid leukemia.
* To determine the complete response rate at the end of induction therapy in these patients.
* To determine the overall survival of patients treated with these regimens.
* To determine the disease-free survival of patients treated with these regimens.
* To determine the event-free survival of patients treated with these regimens.
* To determine toxicity of these regimens.
* To determine compliance related to dose intensity.
OUTLINE:
* Steroids prephase therapy: All patients receive steroids (i.e., prednisone or methylprednisolone) and methotrexate.
* Induction therapy (induction Ia followed by Ib): Patients receive induction Ia comprising vincristine, daunorubicin hydrochloride, asparaginase, and prednisone. They then receive induction Ib comprising cyclophosphamide, mercaptopurine, and cytarabine. Patients who achieve hematological remission proceed to consolidation therapy.
* Consolidation therapy: Patients receive consolidation therapy according to risk group.
* Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.
* High-risk patients: Patients receive consolidation therapy in 3 steps.
* Step 1: Patients receive dexamethasone, vincristine, methotrexate, cytarabine, and asparaginase.
* Step 2: Patients receive dexamethasone, vindesine, methotrexate, ifosfamide, asparaginase, and daunorubicin hydrochloride.
* Step 3: Patients receive dexamethasone, cytarabine, and asparaginase. After completion of consolidation therapy, patients proceed to reinduction therapy.
* Reinduction therapy (reinduction IIa followed by IIb): Patients receive reinduction IIa comprising vincristine, doxorubicin hydrochloride, asparaginase, and dexamethasone. Patients then receive reinduction IIb comprising cyclophosphamide, thioguanine, and cytarabine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Treatment feasibility At 24 months from study entry. To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
- Secondary Outcome Measures
Name Time Method Safety At 3 years from study entry Grade III-IV toxicity events
Disease free survival At three years from study entry Estimation of Disease Free Survival (DFS).
Event free survival At 3 years from study entry Estimation of Event Free Survival (EFS).
Overal survival At 3 years from study entry Compliance At 3 years from study entry Therapy compliance
Trial Locations
- Locations (43)
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
🇮🇹Ancona, Italy
USL 8 - Ospedale S.Donato
🇮🇹Arezzo, Italy
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
🇮🇹Bari, Italy
Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo
🇮🇹Roma, Italy
Divisione di Ematologia Ospedale A. Perrino
🇮🇹Brindisi, Italy
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
🇮🇹Ferrara, Italy
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
🇮🇹Nocera Inferiore, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
🇮🇹Novara, Italy
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
🇮🇹Pisa, Italy
Divisione Ematologia - Università Campus Bio-Medico
🇮🇹Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
🇮🇹Roma, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
🇮🇹Verona, Italy
Ospedale Niguarda " Ca Granda"
🇮🇹Milano, Italy
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
🇮🇹Ascoli Piceno, Italy
Az.Ospedaliera S.G.Moscati
🇮🇹Avellino, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
🇮🇹Catania, Italy
Complesso Ospedaliero S. Giovanni Addolorata
🇮🇹Roma, (rm), Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
🇮🇹Catanzaro, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
🇮🇹Lecce, Italy
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
🇮🇹Genova, Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
🇮🇹Messina, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
🇮🇹Napoli, Italy
UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale"
🇮🇹Napoli, Italy
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
🇮🇹Palermo, Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia
🇮🇹Modena, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
🇮🇹Palermo, Italy
zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
🇮🇹Napoli, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
🇮🇹Parma, Italy
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
🇮🇹Pescara, Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
🇮🇹Ravenna, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
🇮🇹Reggio Calabria, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
🇮🇹Roma, Italy
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
🇮🇹Roma, Italy
Università degli Studi - Policlinico di Tor Vergata
🇮🇹Roma, Italy
Universita Degli Studi "La Sapeinza"
🇮🇹Rome, Italy
Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani
🇮🇹Trani, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
🇮🇹Sassari, Italy
Clinica Ematologica - Policlinico Universitario
🇮🇹Udine, Italy