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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, November 2008
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
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title: "Geriatric Assessment Adapted" Therapy for Ph- ALL Elderly Patients. GIMEMA Protocol LAL1104. EudraCT Code 2005-002156-17

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: May 2007
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
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475280

Contacts
Contact: Marco VIGNETTI, Dr. +39 06 441639831 m.vignetti@gimema.it
Contact: Paola FAZI, Dr. +39 06 441639830 p.fazi@gimema.it

Locations
Italy
Nuovo Ospedale "Torrete" Not yet recruiting
Ancona, Italy
Contact: Pietro Leoni, Prof.            
Az. Ospedaliera S. G. Moscati Not yet recruiting
Avellino, Italy
Contact: Nicola Cantore, Dr            
Ospedale Ferrarotto Not yet recruiting
Catania, Italy
Contact: Rosario Giustolisi, Pr.            
Azienda Ospedaliera Universitaria - Università Federico II Recruiting
Napoli, Italy
Contact: Bruno Rotoli, Pr            
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Recruiting
Napoli, Italy
Contact: Felicetto FERRARA            
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Felicetto FERRARA, Dr. Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" di Napoli
  More Information

GIMEMA's Web page  This link exits the ClinicalTrials.gov site

Publications:
Sandler DP, Ross JA. Epidemiology of acute leukemia in children and adults. Semin Oncol. 1997 Feb;24(1):3-16. Review.
Taylor PR, Reid MM, Bown N, Hamilton PJ, Proctor SJ. Acute lymphoblastic leukemia in patients aged 60 years and over: a population-based study of incidence and outcome. Blood. 1992 Oct 1;80(7):1813-7.
Taylor PR, Reid MM, Proctor SJ. Acute lymphoblastic leukaemia in the elderly. Leuk Lymphoma. 1994 May;13(5-6):373-80. Review.
Kantarjian HM, O'Brien S, Smith T, Estey EH, Beran M, Preti A, Pierce S, Keating MJ. Acute lymphocytic leukaemia in the elderly: characteristics and outcome with the vincristine-adriamycin-dexamethasone (VAD) regimen. Br J Haematol. 1994 Sep;88(1):94-100.
Delannoy A, Ferrant A, Bosly A, Chatelain C, Doyen C, Martiat P, Michaux JL, Sokal G. Acute lymphoblastic leukemia in the elderly. Eur J Haematol. 1990 Aug;45(2):90-3.
Spath-Schwalbe E, Heil G, Heimpel H. Acute lymphoblastic leukemia in patients over 59 years of age. Experience in a single center over a 10-year period. Ann Hematol. 1994 Dec;69(6):291-6.
Ferrari A, Annino L, Crescenzi S, Romani C, Mandelli F. Acute lymphoblastic leukemia in the elderly: results of two different treatment approaches in 49 patients during a 25-year period. Leukemia. 1995 Oct;9(10):1643-7.
Bassan R, Di Bona E, Lerede T, Pogliani E, Rossi G, D'Emilio A, Buelli M, Rambaldi A, Viero P, Rodeghiero F, Barbui T. Age-adapted moderate-dose induction and flexible outpatient postremission therapy for elderly patients with acute lymphoblastic leukemia. Leuk Lymphoma. 1996 Jul;22(3-4):295-301.
Delannoy A, Sebban C, Cony-Makhoul P, Cazin B, Cordonnier C, Bouabdallah R, Cahn JY, Dreyfus F, Sadoun A, Vernant JP, Gay C, Broustet A, Michaux JL, Fiere D. Age-adapted induction treatment of acute lymphoblastic leukemia in the elderly and assessment of maintenance with interferon combined with chemotherapy. A multicentric prospective study in forty patients. French Group for Treatment of Adult Acute Lymphoblastic Leukemia. Leukemia. 1997 Sep;11(9):1429-34.

Study ID Numbers: LAL1104
Study First Received: May 17, 2007
Last Updated: November 7, 2008
ClinicalTrials.gov Identifier: NCT00475280  
Health Authority: Italy: The Italian Medicines Agency

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

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
 Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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