Combination Chemotherapy With or Without Imatinib Mesylate and/or Peripheral Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (LAL0904)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00458848
First received: April 9, 2007
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.


Condition Intervention Phase
Leukemia
Drug: asparaginase
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: idarubicin
Drug: imatinib mesylate
Drug: mercaptopurine
Drug: methotrexate
Drug: methylprednisolone
Drug: mitoxantrone hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Multicenter Phase II Study for the Treatment of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
    Evaluation of disease free survival in patients with high risk of remission obtaining a Complete Remission as from the date of hematological complete remission.


Secondary Outcome Measures:
  • Complete response after HAM [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
    Evaluation, in terms of complete response, of HAM as 2nd line treatment in resistant patients not in progression after the 2nd or 3rd induction cycle

  • Feasibility of minimal residual disease (MRD) monitoring [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
    Feasibility of minimal residual disease in hight and standard risk patients

  • Negative prognostic role of MRD positivity [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
  • Rate of complete hematological response after induction therapy in Ph+ patients [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
  • Disease free survival in Ph+ patients [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
  • Cumulative incidence of relapse [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
  • Molecular monitoring of BCR/ABL after complete hematological response [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: At 4 years from study entry ] [ Designated as safety issue: No ]
    Overall survival from diagnosis


Enrollment: 470
Study Start Date: October 2004
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:

    • Negative myeloperoxidase stain
    • Phenotype T (T-ALL) or B (B-ALL)
    • No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)

PATIENT CHARACTERISTICS:

  • Creatinine ≤ 2.5 mg/dL (after adequate hydration)
  • SGOT and SGPT ≤ 3 times upper limit of normal
  • LVEF ≥ 50%
  • No severe psychiatric disorders
  • No other concurrent malignant disease
  • No presence of documented infections not responding to antibiotic and/or antifungal therapy
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • No prior steroids
  • No prior antiblastic chemotherapy
  • No other concurrent chemotherapy or radiotherapy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458848

  Show 66 Study Locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Study Chair: Roberto Foa, MD Universita Degli Studi "La Sapeinza"
  More Information

Additional Information:
Publications:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00458848     History of Changes
Other Study ID Numbers: LAL0904, GIMEMA-LAL0904, EUDRACT-2004-001738-11
Study First Received: April 9, 2007
Last Updated: May 13, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
B-cell adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia
L1 adult acute lymphoblastic leukemia
L2 adult acute lymphoblastic leukemia
TdT positive adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
6-Mercaptopurine
Methotrexate
Imatinib
Asparaginase
Daunorubicin
Etoposide
Idarubicin
Methylprednisolone Hemisuccinate
Prednisolone
Mitoxantrone
Prednisone
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014