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

This study is currently recruiting participants.
Verified by Gruppo Italiano Malattie EMatologiche dell'Adulto May 2007

Sponsored by:

Gruppo Italiano Malattie EMatologiche dell'Adulto

Information provided by:

Gruppo Italiano Malattie EMatologiche dell'Adulto

ClinicalTrials.gov Identifier:

NCT00475280

 

Purpose

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 II

 

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Number of arms in study:  3

Official Title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17

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]

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


Total Enrollment:  102

Study start: May 2007

Treatment:

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

 

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