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NCT Number: NCT00475280

"Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients

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.

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Key information

Conditions

Leukemia, Lymphoblastic, Acute Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani, Pagani, (SA), Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Geriatric assessment adapted therapy

Procedure

Geriatric assessment is performed before the induction phase starts.

Stem cells autotransplantation

Procedure

Stem cells autotransplantation is performed after consolidation treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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

Acronym: LAL1104

Important dates

Study start
2007
Primary completion
2016
Study completion
2020
First posted
May 21, 2007
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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