Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia (LAL1308)

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:
NCT01156883
First received: July 2, 2010
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.


Condition Intervention
Leukemia
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mercaptopurine
Drug: methotrexate
Drug: methylprednisolone
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Treatment feasibility [ Time Frame: At 24 months from study entry. ] [ Designated as safety issue: No ]
    To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.


Secondary Outcome Measures:
  • Disease free survival [ Time Frame: At three years from study entry ] [ Designated as safety issue: No ]
    Estimation of Disease Free Survival (DFS).

  • Event free survival [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: No ]
    Estimation of Event Free Survival (EFS).

  • Overal survival [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: Yes ]
    Grade III-IV toxicity events

  • Compliance [ Time Frame: At 3 years from study entry ] [ Designated as safety issue: No ]
    Therapy compliance


Estimated Enrollment: 30
Study Start Date: April 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine the feasibility of combination chemotherapy in young adult patients with acute lymphoid leukemia.
  • To determine the complete response rate at the end of induction therapy in these patients.
  • To determine the overall survival of patients treated with these regimens.
  • To determine the disease-free survival of patients treated with these regimens.
  • To determine the event-free survival of patients treated with these regimens.
  • To determine toxicity of these regimens.
  • To determine compliance related to dose intensity.

OUTLINE:

  • Steroids prephase therapy: All patients receive steroids (i.e., prednisone or methylprednisolone) and methotrexate.
  • Induction therapy (induction Ia followed by Ib): Patients receive induction Ia comprising vincristine, daunorubicin hydrochloride, asparaginase, and prednisone. They then receive induction Ib comprising cyclophosphamide, mercaptopurine, and cytarabine. Patients who achieve hematological remission proceed to consolidation therapy.
  • Consolidation therapy: Patients receive consolidation therapy according to risk group.

    • Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.
    • High-risk patients: Patients receive consolidation therapy in 3 steps.

      • Step 1: Patients receive dexamethasone, vincristine, methotrexate, cytarabine, and asparaginase.
      • Step 2: Patients receive dexamethasone, vindesine, methotrexate, ifosfamide, asparaginase, and daunorubicin hydrochloride.
      • Step 3: Patients receive dexamethasone, cytarabine, and asparaginase. After completion of consolidation therapy, patients proceed to reinduction therapy.
  • Reinduction therapy (reinduction IIa followed by IIb): Patients receive reinduction IIa comprising vincristine, doxorubicin hydrochloride, asparaginase, and dexamethasone. Patients then receive reinduction IIb comprising cyclophosphamide, thioguanine, and cytarabine.
  Eligibility

Ages Eligible for Study:   18 Years to 34 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoid leukemia, meeting any of the following criteria:

    • Non-mature B-cell disease
    • Non-Philadelphia chromosome positive disease
    • T -cell or B-cell phenotype

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Prior pretreatment with antiblastic chemotherapy allowed
  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: NCT01156883

Locations
Italy
Complesso Ospedaliero S. Giovanni Addolorata Recruiting
Roma, (rm), Italy, 00184
Contact: Luciana ANNINO, Pr.       lannino@hsangiovanni.roma.it   
Contact: , .         
Principal Investigator: Luciana ANNINO, Pr.         
Sub-Investigator: Anna CHIERICHINI, Dr.         
Azienda Ospedaliera - Nuovo Ospedale "Torrette" Recruiting
Ancona, Italy
Contact: Massimo OFFIDANI, Dr.       m.offidani@ospedaliriuniti.marche.it   
Principal Investigator: Massimo OFFIDANI, Dr.         
Sub-Investigator: Silvia TRAPPOLINI, Dr.         
USL 8 - Ospedale S.Donato Recruiting
Arezzo, Italy
Contact: Antonio Benci, Dr.       ematolar@virgilio.it   
Principal Investigator: Antonio Benci, Dr.         
Sub-Investigator: Alessandra Caremani, Dr.         
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni" Recruiting
Ascoli, Italy
Contact: Piero GALIENI, Pr.       piero.galieni@sanita.marche.it   
Principal Investigator: Piero GALIENI, Pr.         
Sub-Investigator: Catia BIGAZZI, Dr.         
Az.Ospedaliera S.G.Moscati Recruiting
Avellino, Italy
Contact: Nicola Cantore, Dr.       n.cantore@virgilio.it   
Principal Investigator: Nicola Cantore, Dr.         
Sub-Investigator: Lidia Santoro, Dr.         
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari Recruiting
Bari, Italy
Contact: Giorgina Specchia, Pr.       g.specchia@ematba.uniba.it   
Principal Investigator: Giorgina Specchia, Pr.         
Sub-Investigator: Domenico Pastore, Dr.         
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi Recruiting
Bologna, Italy
Contact: Antonio Curti, Dr.       antonio.curti2@unibo.it   
Principal Investigator: Antonio Curti, Dr.         
Sub-Investigator: Giovanni Martinelli, Pr.         
Divisione di Ematologia Ospedale A. Perrino Recruiting
Brindisi, Italy
Contact: Giovanni Quarta, Dr.       quarta.gianni@gmail.com   
Principal Investigator: Giovanni Quarta, Dr.         
Sub-Investigator: Antonio Romano, Dr.         
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" Recruiting
Catania, Italy
Contact: Francesco Di Raimondo, Pr.       diraimon@unict.it   
Principal Investigator: Francesco Di Raimondo, Pr.         
Sub-Investigator: Dorina Cultrera, Dr.         
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia Recruiting
Catanzaro, Italy
Contact: Stefano Molica, Dr.       smolica@libero.it   
Principal Investigator: Stefano Molica, Dr.         
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna Recruiting
Ferrara, Italy
Contact: Antonio Cuneo, Pr.       cut@unife.it   
Principal Investigator: Antonio Cuneo, Pr.         
Sub-Investigator: Gian Matteo Rigolin, Dr.         
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino" Recruiting
Genova, Italy
Contact: Angelo Michele Carella, Pr.       angelomichele.carella@hsanmartino.it   
Principal Investigator: Angelo Michele Carella, Pr.         
Sub-Investigator: Giammatteo Pica, Dr.         
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE Recruiting
Lecce, Italy
Contact: Nicola Di Renzo, Dr.       direnzo.ematolecce@libero.it   
Principal Investigator: Nicola Di Renzo, Dr.         
Sub-Investigator: Michelina Dargenio, Dr.         
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte" Recruiting
Messina, Italy
Contact: Maura BRUGIATELLI, Pr.       mbrugiat@tiscali.it   
Sub-Investigator: Piero TERRIZZI, Dr.         
Principal Investigator: Maura BRUGIATELLI, Pr.         
Ospedale Niguarda " Ca Granda" Recruiting
Milano, Italy
Contact: Alessandra TEDESCHI, Pr.       alessandra.tedeschi@ospedaleniguarda.it   
Principal Investigator: Alessandra TEDESCHI, Pr.         
Sub-Investigator: Antonio GRECO, Dr.         
Centro Oncologico Modenese - Dipartimento di Oncoematologia Recruiting
Modena, Italy
Contact: Mario Luppi, Dr.       mario.luppi@unimore.it   
Principal Investigator: Mario Luppi, Dr.         
UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale" Not yet recruiting
Napoli, Italy
Contact: Gianpaolo MARACACCI, Dr.         
Principal Investigator: Gianpaolo MARACACCI, Dr.         
Sub-Investigator: Emanuela MORELLI, Dr.         
zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia Recruiting
Napoli, Italy
Contact: Fabrizio Pane, Pr.       fabrizio.pane@unina.it   
Principal Investigator: Fabrizio Pane, Pr.         
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Recruiting
Napoli, Italy
Contact: Felicetto Ferrara, Dr.       cut@unife.it   
Principal Investigator: Felicetto Ferrara, Dr.         
Sub-Investigator: Salvatore Palmieri, Dr.         
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I Recruiting
Nocera Inferiore, Italy
Contact: Alfonso Maria D'ARCO, pr.       mardarco@alice.it   
Principal Investigator: Alfonso Maria D'ARCO, Pr.         
Sub-Investigator: Castello CALIFANO, Dr.         
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Recruiting
Novara, Italy
Contact: Gianluca GAIDANO, Dr.       gaidano@med.unipmn.it   
Contact: Monia LUNGHI, Dr.         
Principal Investigator: Gianluca GAIDANO, Pr.         
Sub-Investigator: Monia LUNGHI, Dr.         
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone" Recruiting
Palermo, Italy
Contact: Maria Enza Mitra, Pr.       memitra@yahoo.com   
Principal Investigator: Maria Enza Mitra, Pr.         
Principal Investigator: Maria Raffaela Fadda, Dr.         
Ospedali Riuniti "Villa Sofia-Cervello" Recruiting
Palermo, Italy
Contact: Francesco Fabbiano, Pr.       fabbianofrancesco@tiscali.it   
Principal Investigator: Francesco Fabbiano, Pr.         
Sub-Investigator: Carla Marino, Dr.         
Cattedra di Ematologia CTMO Università degli Studi di Parma Recruiting
Parma, Italy
Contact: Cecilia Caramatti, Dr.       cecilia.caramatti@unipr.it   
Principal Investigator: Cecilia Caramatti, Dr.         
Sub-Investigator: Elena Rosetti, Dr.         
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo Recruiting
Pavia, Italy
Contact: Patrizia Zappasodi, Dr.       p.zappasodi@smatteo.pv.it   
Principal Investigator: Patrizia Zappasodi, Dr.         
U.O. Ematologia Clinica - Azienda USL di Pescara Recruiting
Pescara, Italy
Contact: Giuseppe Fioritoni, Dr.       gfioritoni@tin.it   
Principal Investigator: Giuseppe Fioritoni, Dr.         
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia Recruiting
Pisa, Italy
Contact: Francesco Caracciolo, Dr.       f.caracciolo@med.unipi.it   
Principal Investigator: Francesco Caracciolo, Dr.         
Dipartimento Oncologico - Ospedale S.Maria delle Croci Recruiting
Ravenna, Italy
Contact: Alfonso Zaccaria, Pr.       a.zaccaria@ausl.ra.it   
Principal Investigator: Alfonso Zaccaria, Pr.         
Sub-Investigator: Eliana Zuffa, Dr.         
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" Recruiting
Reggio Calabria, Italy
Contact: Francesco Nobile, Pr.       nobile.franc@gmail.com   
Principal Investigator: Francesco Nobile, Pr.         
Sub-Investigator: Francesca Ronco, Dr.         
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Recruiting
Reggio Emilia, Italy
Contact: Francesco Merli, Pr.       francesco.merli@asmn.re.it   
Principal Investigator: Francesco Merli, Pr.         
Sub-Investigator: Annalisa Imovili, Dr.         
U.O.C. Ematologia - Ospedale S.Eugenio Recruiting
Roma, Italy
Contact: Paolo De Fabritiis, Pr.       paolo.de.fabritiis@uniroma2.it   
Principal Investigator: Paolo De Fabritiis, Pr.         
Principal Investigator: Giovanni Del Poeta, Dr.         
Divisione Ematologia - Università Campus Bio-Medico Recruiting
Roma, Italy
Contact: Giuseppe AVVISATI, Pr.       g.avvisati@unicampus.it   
Principal Investigator: Giuseppe AVVISATI, Pr.         
Sub-Investigator: Ombretta ANNIBALI, Dr.         
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena Not yet recruiting
Roma, Italy
Contact: Maria Concetta PETTI, Pr.         
Principal Investigator: Maria Concetta PETTI, Pr.         
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Recruiting
Roma, Italy
Contact: Simona Sica       s.sica@rm.unicatt.it   
Principal Investigator: Simona Sica, Dr.         
Università degli Studi - Policlinico di Tor Vergata Recruiting
Roma, Italy
Contact: Sergio Amadori, Pr.       sergio.amadori@ptvonline.it   
Principal Investigator: Sergio Amadori, Pr.         
Sub-Investigator: Adriano Venditti, Pr.         
Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo Recruiting
Roma, Italy
Contact: Leonardo Pacilli, Dr.       lpacilli@scamilloforlanini.rm.it   
Principal Investigator: Leonardo Pacilli, Dr.         
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia Recruiting
Roma, Italy
Contact: Antonella Ferrari, Dr.       antonella.ferrari7@tin.it   
Principal Investigator: Antonella Ferrari, Dr.         
Sub-Investigator: Maria Paola, Dr.         
Universita Degli Studi "La Sapeinza" Recruiting
Rome, Italy, 00161
Contact: Contact Person    39-6-8579-5753    rfoa@bce.uniroma1.it   
Principal Investigator: Roberto FOA', Pr.         
Sub-Investigator: Anna Maria TESTI, Pr.         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
S. G. Rotondo, Italy
Contact: Nicola Cascavila, Pr.       n.cascavilla@operapadrepio.it   
Principal Investigator: Nicola Cascavilla, Pr.         
Principal Investigator: Lorella Melillo, Dr.         
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia Recruiting
Sassari, Italy
Contact: Maurizio Longinotti, Pr.       longinot@uniss.it   
Principal Investigator: Maurizio Longinotti, Pr.         
Sub-Investigator: Claudio Fozza, Dr.         
Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani Recruiting
Trani, Italy
Contact: Giuseppe Tarantini, Dr.       giuseppetarantini0@gmail.com   
Principal Investigator: Giuseppe Tarantini, Dr.         
Sub-Investigator: Caterina Buquicchio, Dr.         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Anna Candoni, Dr.       candoni.anna@aoud.sanita.fvg.it   
Principal Investigator: Anna Candoni, 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.       giovanni.pizzolo@univr.it   
Principal Investigator: Giovanni Pizzolo, Pr.         
Sub-Investigator: Massimiliano Bonifacio, Dr.         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Roberto Foa, MD Universita Degli Studi "La Sapeinza"
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01156883     History of Changes
Other Study ID Numbers: LAL1308, GIMEMA-LAL1308, EU-21042
Study First Received: July 2, 2010
Last Updated: March 20, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
B-cell adult acute lymphoblastic leukemia
recurrent adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
untreated adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Asparaginase
Cyclophosphamide
Daunorubicin
Dexamethasone
Doxorubicin
Liposomal doxorubicin
Methotrexate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Vincristine
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antiemetics

ClinicalTrials.gov processed this record on October 30, 2014