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 : September 13, 2021
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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 |
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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 |
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.
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Consolidation therapy: Patients receive consolidation therapy according to risk group.
- Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.
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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) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | October 31, 2017 |
Actual Study Completion Date : | October 31, 2017 |

- 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 ]
- Safety [ Time Frame: At 3 years from study entry ]Grade III-IV toxicity events
- Compliance [ Time Frame: At 3 years from study entry ]Therapy compliance

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Ages Eligible for Study: | 18 Years to 34 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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

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" |
Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
ClinicalTrials.gov Identifier: | NCT01156883 |
Other Study ID Numbers: |
LAL1308 GIMEMA-LAL1308 EU-21042 |
First Posted: | July 5, 2010 Key Record Dates |
Last Update Posted: | September 13, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
B-cell adult acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia T-cell adult acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Leukemia, Lymphoid Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Dexamethasone Prednisone Methylprednisolone Cyclophosphamide Ifosfamide |
Doxorubicin Liposomal doxorubicin Methotrexate Vincristine Daunorubicin Asparaginase Mercaptopurine Thioguanine Vindesine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents |