Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT01156883
Last Updated: 2021-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2010-04-30
2017-10-31
Brief Summary
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PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
doxorubicin hydrochloride
ifosfamide
mercaptopurine
methotrexate
methylprednisolone
prednisone
thioguanine
vincristine sulfate
vindesine
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
34 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Roberto Foa, MD
Role: PRINCIPAL_INVESTIGATOR
Universita Degli Studi "La Sapeinza"
Locations
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Complesso Ospedaliero S. Giovanni Addolorata
Roma, (RM), Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, , Italy
USL 8 - Ospedale S.Donato
Arezzo, , Italy
Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
Ascoli Piceno, , 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"
Milan, , 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
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni 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
Countries
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References
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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.
Other Identifiers
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GIMEMA-LAL1308
Identifier Type: -
Identifier Source: secondary_id
EU-21042
Identifier Type: -
Identifier Source: secondary_id
LAL1308
Identifier Type: -
Identifier Source: org_study_id
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