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

September 6, 2021 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Azienda Ospedaliera - Nuovo Ospedale "Torrette"
      • Arezzo, Italy
        • USL 8 - Ospedale S.Donato
      • Ascoli Piceno, Italy
        • Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
      • Avellino, Italy
        • Az.Ospedaliera S.G.Moscati
      • Bari, Italy
        • UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
      • Bologna, Italy
        • Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
      • Brindisi, Italy
        • Divisione di Ematologia Ospedale A. Perrino
      • Catania, Italy
        • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
      • Catanzaro, Italy
        • Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
      • Ferrara, Italy
        • Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
      • Genova, Italy
        • Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
      • Lecce, Italy
        • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
      • Messina, Italy
        • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
      • Milano, Italy
        • Ospedale Niguarda " Ca Granda"
      • Modena, Italy
        • Centro Oncologico Modenese - Dipartimento di Oncoematologia
      • Napoli, Italy
        • Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
      • Napoli, Italy
        • zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Napoli, Italy
        • UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale"
      • Nocera Inferiore, Italy
        • Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
      • Novara, Italy
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
      • Palermo, Italy
        • Ospedali Riuniti "Villa Sofia-Cervello"
      • Palermo, Italy
        • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
      • Parma, Italy
        • Cattedra di Ematologia CTMO Università degli Studi di Parma
      • Pavia, Italy
        • S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
      • Pescara, Italy
        • U.O. Ematologia Clinica - Azienda USL di Pescara
      • Pisa, Italy
        • Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
      • Ravenna, Italy
        • Dipartimento Oncologico - Ospedale S.Maria delle Croci
      • Reggio Calabria, Italy
        • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
      • Reggio Emilia, Italy
        • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
      • Roma, Italy
        • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
      • Roma, Italy
        • U.O.C. Ematologia - Ospedale S.Eugenio
      • Roma, Italy
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma, Italy
        • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
      • Roma, Italy
        • Università degli Studi - Policlinico di Tor Vergata
      • Roma, Italy
        • Divisione Ematologia - Università Campus Bio-Medico
      • Roma, Italy
        • Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo
      • Rome, Italy, 00161
        • Universita Degli Studi "La Sapeinza"
      • San Giovanni Rotondo, Italy
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Sassari, Italy
        • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
      • Trani, Italy
        • Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani
      • Udine, Italy
        • Clinica Ematologica - Policlinico Universitario
      • Verona, Italy
        • Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
    • (rm)
      • Roma, (rm), Italy, 00184
        • Complesso Ospedaliero S. Giovanni Addolorata

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 24 months from study entry.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: At three years from study entry
Estimation of Disease Free Survival (DFS).
At three years from study entry
Event free survival
Time Frame: At 3 years from study entry
Estimation of Event Free Survival (EFS).
At 3 years from study entry
Overal survival
Time Frame: At 3 years from study entry
At 3 years from study entry
Safety
Time Frame: At 3 years from study entry
Grade III-IV toxicity events
At 3 years from study entry
Compliance
Time Frame: At 3 years from study entry
Therapy compliance
At 3 years from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 5, 2010

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAL1308
  • GIMEMA-LAL1308
  • EU-21042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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