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

Primary Purpose

Leukemia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
doxorubicin hydrochloride
ifosfamide
mercaptopurine
methotrexate
methylprednisolone
prednisone
thioguanine
vincristine sulfate
vindesine
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring B-cell adult acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia

Eligibility Criteria

18 Years - 34 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Treatment feasibility
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
Estimation of Disease Free Survival (DFS).
Event free survival
Estimation of Event Free Survival (EFS).
Overal survival
Safety
Grade III-IV toxicity events
Compliance
Therapy compliance

Full Information

First Posted
July 2, 2010
Last Updated
September 6, 2021
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT01156883
Brief Title
Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia
Acronym
LAL1308
Official Title
Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
B-cell adult acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
asparaginase
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
mercaptopurine
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
thioguanine
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Drug
Intervention Name(s)
vindesine
Primary Outcome Measure Information:
Title
Treatment feasibility
Description
To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.
Time Frame
At 24 months from study entry.
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Estimation of Disease Free Survival (DFS).
Time Frame
At three years from study entry
Title
Event free survival
Description
Estimation of Event Free Survival (EFS).
Time Frame
At 3 years from study entry
Title
Overal survival
Time Frame
At 3 years from study entry
Title
Safety
Description
Grade III-IV toxicity events
Time Frame
At 3 years from study entry
Title
Compliance
Description
Therapy compliance
Time Frame
At 3 years from study entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Foa, MD
Organizational Affiliation
Universita Degli Studi "La Sapeinza"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complesso Ospedaliero S. Giovanni Addolorata
City
Roma
State/Province
(rm)
ZIP/Postal Code
00184
Country
Italy
Facility Name
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
City
Ancona
Country
Italy
Facility Name
USL 8 - Ospedale S.Donato
City
Arezzo
Country
Italy
Facility Name
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
City
Ascoli Piceno
Country
Italy
Facility Name
Az.Ospedaliera S.G.Moscati
City
Avellino
Country
Italy
Facility Name
UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari
City
Bari
Country
Italy
Facility Name
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
City
Bologna
Country
Italy
Facility Name
Divisione di Ematologia Ospedale A. Perrino
City
Brindisi
Country
Italy
Facility Name
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
City
Catanzaro
Country
Italy
Facility Name
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
City
Ferrara
Country
Italy
Facility Name
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino"
City
Genova
Country
Italy
Facility Name
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
City
Lecce
Country
Italy
Facility Name
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
City
Messina
Country
Italy
Facility Name
Ospedale Niguarda " Ca Granda"
City
Milano
Country
Italy
Facility Name
Centro Oncologico Modenese - Dipartimento di Oncoematologia
City
Modena
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
City
Napoli
Country
Italy
Facility Name
UOSC di Ematologia Oncologica - Istituto Nazionale Tumori "Fondazione Senatore Giovanni Pascale"
City
Napoli
Country
Italy
Facility Name
zienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
City
Napoli
Country
Italy
Facility Name
Inferiore U.O. Medicina Interna Ematologia ed Oncologia P.O. Umberto I
City
Nocera Inferiore
Country
Italy
Facility Name
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
City
Novara
Country
Italy
Facility Name
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
City
Palermo
Country
Italy
Facility Name
Ospedali Riuniti "Villa Sofia-Cervello"
City
Palermo
Country
Italy
Facility Name
Cattedra di Ematologia CTMO Università degli Studi di Parma
City
Parma
Country
Italy
Facility Name
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
City
Pavia
Country
Italy
Facility Name
U.O. Ematologia Clinica - Azienda USL di Pescara
City
Pescara
Country
Italy
Facility Name
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
City
Pisa
Country
Italy
Facility Name
Dipartimento Oncologico - Ospedale S.Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
City
Reggio Calabria
Country
Italy
Facility Name
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
City
Roma
Country
Italy
Facility Name
Divisione di Ematologia - Ospedale S. Camillo Divisione di Ematologia - Ospedale S. Camillo
City
Roma
Country
Italy
Facility Name
Divisione Ematologia - Università Campus Bio-Medico
City
Roma
Country
Italy
Facility Name
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
City
Roma
Country
Italy
Facility Name
U.O.C. Ematologia - Ospedale S.Eugenio
City
Roma
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
City
Roma
Country
Italy
Facility Name
Università degli Studi - Policlinico di Tor Vergata
City
Roma
Country
Italy
Facility Name
Universita Degli Studi "La Sapeinza"
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
City
Sassari
Country
Italy
Facility Name
Struttura Complessa Ematologia - Azienda Sanitaria Locale BAT1- Presidio Ospedaliero Bisceglie-Trani
City
Trani
Country
Italy
Facility Name
Clinica Ematologica - Policlinico Universitario
City
Udine
Country
Italy
Facility Name
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
City
Verona
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34048072
Citation
Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.
Results Reference
derived

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Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

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