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

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ClinicalTrials.gov Identifier: NCT00475280
Recruitment Status : Unknown
Verified August 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was:  Active, not recruiting
First Posted : May 21, 2007
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
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 or disease Intervention/treatment Phase
Leukemia, Lymphoblastic, Acute Procedure: Geriatric assessment adapted therapy Procedure: Stem cells autotransplantation Phase 2

Detailed Description:

Treatment:

  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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17
Actual Study Start Date : November 2007
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : October 1, 2018


Arm Intervention/treatment
Geriatric assessment 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




Primary Outcome Measures :
  1. 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 :
  1. Complete Response rate [ Time Frame: After induction therapy ]
  2. Stem cell autotransplant feasibility [ Time Frame: At 6 months from diagnosis ]
  3. Incidence of adult ALL [ Time Frame: At diagnosis ]
  4. Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60 [ Time Frame: At diagnosis and during follow-up ]
  5. Disease free survival [ Time Frame: During follow-up ]


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

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

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): NCT00475280


Locations
Show Show 32 study locations
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Felicetto FERRARA, Dr. Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli
Publications:

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00475280    
Other Study ID Numbers: LAL1104
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases