Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia (LAL1308)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01156883
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : September 13, 2021
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

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

Detailed Description:


  • 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.

Layout table for study information
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: At three years from study entry ]
    Estimation of Disease Free Survival (DFS).

  2. Event free survival [ Time Frame: At 3 years from study entry ]
    Estimation of Event Free Survival (EFS).

  3. Overal survival [ Time Frame: At 3 years from study entry ]
  4. Safety [ Time Frame: At 3 years from study entry ]
    Grade III-IV toxicity events

  5. Compliance [ Time Frame: At 3 years from study entry ]
    Therapy compliance

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • Prior pretreatment with antiblastic chemotherapy allowed

Information from the National Library of Medicine

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 identifier (NCT number): NCT01156883

Show Show 43 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Layout table for investigator information
Principal Investigator: Roberto Foa, MD Universita Degli Studi "La Sapeinza"
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier: NCT01156883    
Other Study ID Numbers: LAL1308
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
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
B-cell adult acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
Additional relevant MeSH terms:
Layout table for MeSH terms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents