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

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ClinicalTrials.gov Identifier: NCT01156883
Recruitment Status : Completed
First Posted : July 5, 2010
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
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 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
Study Start Date : April 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : January 2018

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Treatment feasibility [ Time Frame: At 24 months from study entry. ]
    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 :
  1. Disease free survival [ Time Frame: At three years from study entry ]
    Estimation of Disease Free Survival (DFS).

  2. Event free survival [ Time Frame: At 3 years from study entry ]
    Estimation of Event Free Survival (EFS).

  3. Overal survival [ Time Frame: At 3 years from study entry ]
  4. Toxicity [ Time Frame: At 3 years from study entry ]
    Grade III-IV toxicity events

  5. Compliance [ Time Frame: At 3 years from study entry ]
    Therapy compliance


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156883


Locations
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Italy
Complesso Ospedaliero S. Giovanni Addolorata
Roma, (rm), Italy, 00184
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
USL 8 - Ospedale S.Donato
Arezzo, Italy
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli, Italy
Az.Ospedaliera S.G.Moscati
Avellino, Italy
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
Bari, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
Divisione di Ematologia Ospedale A. Perrino
Brindisi, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
Ferrara, Italy
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
Genova, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina, Italy
Ospedale Niguarda " Ca Granda"
Milano, Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia
Modena, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy
UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale"
Napoli, Italy
zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, Italy
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
Nocera Inferiore, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
Pisa, Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci
Ravenna, Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
Roma, Italy
Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo
Roma, Italy
Divisione Ematologia - Università Campus Bio-Medico
Roma, Italy
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Università degli Studi - Policlinico di Tor Vergata
Roma, Italy
Universita Degli Studi "La Sapeinza"
Rome, Italy, 00161
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
S. G. Rotondo, Italy
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
Sassari, Italy
Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani
Trani, Italy
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Roberto Foa, MD Universita Degli Studi "La Sapeinza"
More Information
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01156883     History of Changes
Other Study ID Numbers: LAL1308
GIMEMA-LAL1308
EU-21042
First Posted: July 5, 2010    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisone
Methylprednisolone
Cyclophosphamide
Doxorubicin
 Methotrexate
Vincristine
Ifosfamide
Daunorubicin
Asparaginase
Mercaptopurine
Thioguanine
Vindesine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids