Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
18 Years
34 Years
Both
Leukemia
Trial Information
Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of acute lymphoid leukemia, meeting any of the following criteria:
- Non-mature B-cell disease
- Non-Philadelphia chromosome positive disease
- T -cell or B-cell phenotype
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Prior pretreatment with antiblastic chemotherapy allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment feasibility
Outcome Description:
To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
Outcome Time Frame:
At 24 months from study entry.
Safety Issue:
No
Principal Investigator
Roberto Foa, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universita Degli Studi "La Sapeinza"
Authority:
Italy: Ethics Committee
Study ID:
LAL1308
NCT ID:
NCT01156883
Start Date:
April 2010
Completion Date:
February 2015
Related Keywords:
- Leukemia
- B-cell adult acute lymphoblastic leukemia
- recurrent adult acute lymphoblastic leukemia
- T-cell adult acute lymphoblastic leukemia
- untreated adult acute lymphoblastic leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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