Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia (LAL1308)
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|ClinicalTrials.gov Identifier: NCT01156883|
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : February 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: mercaptopurine Drug: methotrexate Drug: methylprednisolone Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Drug: vindesine||Not Applicable|
- 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.
- 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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||January 2018|
- Treatment feasibility [ Time Frame: 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.
- Disease free survival [ Time Frame: At three years from study entry ]Estimation of Disease Free Survival (DFS).
- Event free survival [ Time Frame: At 3 years from study entry ]Estimation of Event Free Survival (EFS).
- Overal survival [ Time Frame: At 3 years from study entry ]
- Toxicity [ Time Frame: At 3 years from study entry ]Grade III-IV toxicity events
- Compliance [ Time Frame: At 3 years from study entry ]Therapy compliance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156883
|Principal Investigator:||Roberto Foa, MD||Universita Degli Studi "La Sapeinza"|