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

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)

Overall Status

Completed

CT.gov ID

NCT01156883

Collaborator

(none)

Enrollment

Locations

Duration (Months)

1.8

Patients Per Site

Patients Per Site Per Month

Study Details

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.

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	N/A

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

Study Type:

Interventional

Actual Enrollment :

76 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 :

Apr 1, 2010

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Oct 31, 2017

Outcome Measures

Primary Outcome Measures

Treatment feasibility [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

Disease free survival [At three years from study entry]
Estimation of Disease Free Survival (DFS).
Event free survival [At 3 years from study entry]
Estimation of Event Free Survival (EFS).
Overal survival [At 3 years from study entry]
Safety [At 3 years from study entry]
Grade III-IV toxicity events
Compliance [At 3 years from study entry]
Therapy compliance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 34 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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