Combination Chemotherapy in Treating Young Adult Patients NCT01156883

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01156883
Other study ID #	LAL1308
Secondary ID	GIMEMA-LAL1308EU
Status	Completed
Phase	N/A
First received
Last updated
Start date	April 2010
Est. completion date	October 31, 2017

Study information
Verified date	September 2021
Source	Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	76
Est. completion date	October 31, 2017
Est. primary completion date	October 31, 2017
Accepts healthy volunteers	No
Gender	All
Age group	18 Years to 34 Years
Eligibility	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 Design

Related Conditions & MeSH terms

Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• asparaginase

• cyclophosphamide

• cytarabine

• daunorubicin hydrochloride

• dexamethasone

• doxorubicin hydrochloride

• ifosfamide

• mercaptopurine

• methotrexate

• methylprednisolone

• prednisone

• thioguanine

• vincristine sulfate

• vindesine

Locations
Country	Name	City	State
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"	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	Complesso Ospedaliero S. Giovanni Addolorata	Roma	(rm)
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

Sponsors *(1)*
Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy,

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

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Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

Outcome