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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014