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

This study is currently recruiting participants.
Verified March 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00475280
First received: May 17, 2007
Last updated: March 20, 2014
Last verified: March 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete Response rate [ Time Frame: After induction therapy ] [ Designated as safety issue: No ]
  • Stem cell autotransplant feasibility [ Time Frame: At 6 months from diagnosis ] [ Designated as safety issue: No ]
  • Incidence of adult ALL [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
  • Evaluation of molecular, cytogenetics and immunophenotype heterogeneity in ph negative ALL patients >60 [ Time Frame: At diagnosis and during follow-up ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: During follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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:

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" Recruiting
Ancona, Italy
Contact: Massimo Offidani, Dr.         
Principal Investigator: Massimo Offidani, Dr.         
Sub-Investigator: Silvia Trappolini, Dr.         
USL 8 - Ospedale S.Donato Recruiting
Arezzo, Italy
Contact: Antonio Benci, Dr.         
Principal Investigator: Antonio Benci, Dr.         
Sub-Investigator: Alessandra Caremani, Dr.         
Az. Ospedaliera S. G. Moscati Recruiting
Avellino, Italy
Contact: Nicola Cantore, Dr         
Principal Investigator: Nicola Cantore, Dr.         
Sub-Investigator: Gabriella Storti, Dr.         
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi Suspended
Bologna, Italy
Ospedale Ferrarotto Recruiting
Catania, Italy
Contact: Francesco Di Raimondo, Pr.         
Principal Investigator: Francesco Di Raimondo, Pr.         
Sub-Investigator: Alessandra Cupri, Dr.         
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia Recruiting
Catanzaro, Italy
Contact: Stefano Molica, Dr.         
Principal Investigator: Stefano Molica, Dr.         
Sub-Investigator: Maria Grazia Kropp, Dr.         
Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile Recruiting
Civitanova Marche, Italy
Contact: Riccardo Centurioni, Dr.         
Principal Investigator: Riccardo Centurioni, Dr.         
Sub-Investigator: Angela Tassetti, Dr.         
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi Recruiting
Ferrara, Italy
Contact: Antonio Cuneo         
Principal Investigator: Antonio Cuneo         
Sub-Investigator: Gian Matteo Rigolin         
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino" Recruiting
Genova, Italy
Contact: Angelo Michele Carella, Dr.         
Principal Investigator: Angelo Michele Carella, Dr.         
Sub-Investigator: Giammatteo Pica, Dr.         
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE Recruiting
Lecce, Italy
Contact: Vincenzo Pavone, Dr.         
Principal Investigator: Vincenzo Pavone, Dr.         
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina Recruiting
Messina, Italy
Contact: Caterina Musolino, Dr.         
Principal Investigator: Caterina Musolino, Dr.         
Sub-Investigator: Giuseppina Penna, Dr.         
Centro Oncologico Modenese - Dipartimento di Oncoematologia Recruiting
Modena, Italy
Contact: Mario Luppi, Dr.         
Principal Investigator: Mario Luppi, Dr.         
Azienda Ospedaliera Universitaria - Università Federico II Recruiting
Napoli, Italy
Contact: Fabeizio Pane, Pr         
Principal Investigator: Fabrizio Pane, Pr.         
Sub-Investigator: Giuseppe Cerciello, Dr.         
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Recruiting
Napoli, Italy
Contact: Felicetto FERRARA         
Principal Investigator: Felicetto Ferrara, Dr.         
Sub-Investigator: Barbara Pocali, Dr.         
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I Recruiting
Nocera Inferiore, Italy
Contact: Alfonso Maria D'Arco, Dr.         
Principal Investigator: Alfonso Maria D'Arco, Dr.         
Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga Recruiting
Orbassano, Italy
Contact: Daniela Cilloni, Dr.         
Principal Investigator: Daniela Cilloni, Dr.         
Sub-Investigator: Emanuela Messa, Dr.         
La Maddalena Casa di Cura di Alta Specialità Dipartimento Oncologico di III Livello Recruiting
Palermo, Italy
Contact: Maurizio Musso         
Principal Investigator: Maurizio Musso         
Sub-Investigator: Alessandra Crescimanno         
Cattedra di Ematologia CTMO Università degli Studi di Parma Recruiting
Parma, Italy
Contact: Cecilia Caramatti, Dr.         
Principal Investigator: Cecilia Caramatti, Dr.         
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" Recruiting
Reggio Calabria, Italy
Contact: Francesco Nobile, Pr.         
Principal Investigator: Francesco Nobile, Pr.         
Sub-Investigator: Francesca Ronco, Dr.         
UO di Ematologia Centro Oncologico Basilicata Recruiting
Rionero in Vulture, Italy
Contact: Pellegrino Musto, Dr.         
Principal Investigator: Pellegrino Musto, Dr.         
Sub-Investigator: Giuseppe Pietrantuono, Dr.         
Complesso Ospedaliero S. Giovanni Addolorata Recruiting
Roma, Italy
Contact: Luciana Annino, Pr.         
Principal Investigator: Luciana Annino, Pr.         
Sub-Investigator: Anna Chierichini, Dr.         
Divisione Ematologia - Università Campus Bio-Medico Recruiting
Roma, Italy
Contact: Giuseppe AVVISATI, PR.         
Principal Investigator: Giuseppe Avvisati, Pr.         
Sub-Investigator: Ombretta Annibali, Dr.         
Segreteria di Ematologia - S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena Recruiting
Roma, Italy
Contact: Antonio Spadea, Dr.         
Principal Investigator: Antonio Spadea, Dr.         
Sub-Investigator: Laura Dessanti, Dr.         
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Recruiting
Roma, Italy
Contact: Roberto Foà, Pr.         
Principal Investigator: Roberto Foà, Pr.         
Sub-Investigator: Giovanna Meloni, Pr.         
U.O.C. Ematologia - Ospedale S.Eugenio Recruiting
Roma, Italy
Contact: Paolo De Fabritiis, Pr.         
Sub-Investigator: Benedetta Neri, Dr.         
Principal Investigator: Paolo De Fabritiis, Pr.         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
San Giovanni Rotondo, Italy
Contact: Nicola Cascavilla, Pr.         
Principal Investigator: Nicola Cascavilla, Pr.         
Sub-Investigator: Lorella Melillo, Dr.         
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia Recruiting
Sassari, Italy
Contact: Maurizio Longinotti, Pr.         
Principal Investigator: Maurizio Longinotti, Pr.         
Sub-Investigator: Rosa Maria Nieddu, Dr.         
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte" Recruiting
Siena, Italy
Contact: Monica Bocchia, Pr.         
Principal Investigator: Monica Bocchia, Pr.         
Sub-Investigator: Michela Rondoni, Dr.         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Anna Candoni, Dr.         
Principal Investigator: Anna Candoni, Dr.         
Sub-Investigator: Erica Simeone, Dr.         
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi Recruiting
Verona, Italy
Contact: Giovanni Pizzolo, Pr.         
Principal Investigator: Giovanni Pizzolo, Pr.         
Sub-Investigator: Massimiliano Bonifacio, Dr.         
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

Additional Information:
Publications:

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00475280     History of Changes
Other Study ID Numbers: LAL1104
Study First Received: May 17, 2007
Last Updated: March 20, 2014
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

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014