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Completed

NCT Number: NCT01156883

Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complesso Ospedaliero S. Giovanni Addolorata, Roma, (RM), Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment

Acronym: LAL1308

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jul 5, 2010
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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