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

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.
 
ClinicalTrials.gov Identifier: NCT00458848
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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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. 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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study 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.
Study Start Date : October 2004
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Imatinib

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Reaching Disease Free Survival [ Time Frame: At 60 months ]

Secondary Outcome Measures :
  1. Number of Patients Reaching Complete Hematological Response After Induction Therapy [ Time Frame: At the end of induction, day +50 ]
  2. Percentage of Participants Reaching Overall Survival [ Time Frame: At 60 months ]
    Overall survival from diagnosis


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00458848


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

Publications of Results:

Other Publications:

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00458848    
Other Study ID Numbers: LAL0904
LAL0904 ( Other Identifier: GIMEMA )
2004-001738-11 ( Other Identifier: EudraCT )
First Posted: April 11, 2007    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: September 2018
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:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Methylprednisolone
Methotrexate
Etoposide
Vincristine
Imatinib Mesylate
 Daunorubicin
Asparaginase
Mercaptopurine
Mitoxantrone
Idarubicin
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents