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"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients (LAL1104)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier:
First received: May 17, 2007
Last updated: July 13, 2016
Last verified: July 2016
This study aims at considering clinical heterogeneity of patients based on a "geriatric assessment" without taking into account the real age of the subject. This will allow physicians to adapt therapy according to three different groups of patients: frail, fit and intermediate and to evaluate the efficacy and feasibility of a therapy adapted to the different categories of patients.

Condition Intervention Phase
Leukemia, Lymphoblastic, Acute
Procedure: Geriatric assessment adapted therapy
Procedure: Stem cells autotransplantation
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Overall survival in Ph negative ALL patients stratified according to a geriatric assessment [ Time Frame: at 6 months from diagnosis for the Frail group of pts and at 2 years from diagnosis for the Fit and Intermediate group of patients ]

Secondary Outcome Measures:
  • Complete Response rate [ Time Frame: After induction therapy ]
  • Stem cell autotransplant feasibility [ Time Frame: At 6 months from diagnosis ]
  • Incidence of adult ALL [ Time Frame: At diagnosis ]
  • Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60 [ Time Frame: At diagnosis and during follow-up ]
  • Disease free survival [ Time Frame: During follow-up ]

Estimated Enrollment: 102
Study Start Date: November 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Geriatric assessment adapted therapy
    Geriatric assessment is performed before the induction phase starts.
    Procedure: Stem cells autotransplantation
    Stem cells autotransplantation is performed after consolidation treatment
Detailed Description:


  1. Frail patients:

    • Pretreatment with PDN
    • Induction with Vinblastine and PDN
    • Maintenance with MTX, 6-MP, VBL and PDN
  2. Fit patients:

    • Pretreatment with PDN
    • Induction with VCR, DNR and PDN
    • Consolidation with MTX, ARA-C and G-CSF
    • Autologous transplantation
    • Maintenance with MTX, 6-MP, VCR, and PDN
  3. Intermediate patients:

    • Pretreatment with PDN
    • Induction with VCR, DNR and PDN
    • Consolidation with MTX, ARA-C and G-CSF
    • A second cycle of consolidation therapy
    • Maintenance with MTX, 6-MP, VCR, and PDN

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 60 years old
  • Cytomorphologic and immunophenotypic diagnosis of ALL (all FAB groups except L3 and all immunophenotypes except SmIg+ B-ALL)
  • Signed informed consent

Exclusion Criteria:

  • Age <= 60 years old
  • Ph+ ALL
  • Refuse to sign informed consent
  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 identifier: NCT00475280

Contact: Marco VIGNETTI, Dr. +39 06 441639831
Contact: Paola FAZI, Dr. +39 06 441639830

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Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Principal Investigator: Felicetto FERRARA, Dr. Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli
  More Information


Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto Identifier: NCT00475280     History of Changes
Other Study ID Numbers: LAL1104
Study First Received: May 17, 2007
Last Updated: July 13, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
geriatric assessment adapted therapy
Leukemia, Lymphoblastic, Acute
Older patients
> 60 years old
Ph negative

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on April 21, 2017