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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Treatment feasibility
To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
Time frame: At 24 months from study entry.
Disease free survival
Estimation of Disease Free Survival (DFS).
Time frame: At three years from study entry
Event free survival
Estimation of Event Free Survival (EFS).
Time frame: At 3 years from study entry
Overal survival
Time frame: At 3 years from study entry
Safety
Grade III-IV toxicity events
Time frame: At 3 years from study entry
Compliance
Therapy compliance
Time frame: At 3 years from study entry
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Complesso Ospedaliero S. Giovanni Addolorata
Roma, (RM), Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
USL 8 - Ospedale S.Donato
Arezzo, Italy
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno, Italy
Az.Ospedaliera S.G.Moscati
Avellino, Italy
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Bari, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
Divisione di Ematologia Ospedale A. Perrino
Brindisi, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
...and 33 more locations