PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00494897

Collaborator

(none)

374

Enrollment

Locations

138

Duration (Months)

4.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of current protocol is try improve the results of chemotherapy treatment in patients with ALL wich is not indicated the peripheral stem cell transplant in first remission, with an intensive consolidation follow by re-inductions.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Asparaginase Drug: Cyclophosphamide Drug: Cytarabine Drug: Daunorubicin Drug: Mercaptopurine Drug: Prednisone Drug: Vincristine Drug: Methotrexate Procedure: Intrathecally treatment	Phase 4

Detailed Description

Induction therapy:

Patients with standard risk receive vincristine (1,5 mg/m2)IV on days 1, 8, 15 and 22;daunorubicin (30 mg/m2)IV on days 1, 8, 15 and 22; oral or IV prednisone 60 mg/m2/day, days 1 to 27 and 30 mg/m2/day, days 28 to 35;asparaginase 10.000 UI/m2 IM or IV, days 10 to 12, 17 to 19 and 24 to 26;cyclophosphamide (500 mg/m2)IV days 1, 2 and 29; methotrexate, cytosine arabinoside and hydrocortisone, days 1 to 22.

Patients older than 55 years are not treated with asparaginase and cyclophosphamide.

Consolidation therapy (1):

Standard risk: Mercaptopurine 50 mg/m2, PO, days 1 to 7, 28-35 and 56-63; methotrexate (3g/m2)IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV, days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Patients over 50 years: Mercaptopurine (50 mg/m2), PO, days 1 to 7, 28-35 and 56-63;methotrexate (1,5 g/m2) IV/24 hours, day 1, 28 and 56; VM-26 (150 mg/m2)/12 hours, IV days 14 and 42; ARA-C (500 mg/m2)/12 hours, IV days 14-15 and 42-43; intrathecally treatment, days 1, 28 and 56.

Consolidation therapy (2)/Reinduction: one cycle similar to induction. It starts one week after last dose of mercaptopurine.Dexamethasone 10 mg/m2/day,PO or IV, days 1-14 and 5 mg/m2/day, PO or IV days 15-21; VCR: 1,5 mg/m2 IV, days 1, 8 and 15; Daunorubicin 30 mg/m2

IV, days 1, 2, 8 and 9; cyclophosphamide 600 mg/m2/day IV, days 1 and 15; Asparaginase:

10.000 UI/m2 IM or IV, days 1-3 and 15-17;intrathecally treatment days 1 and 15

Maintenance therapy 1:administration of continuous chemotherapy (mercaptopurine and methotrexate) and reinductions until one year from diagnosis.

Continuous chemotherapy:
MP 50 mg/m2/day PO
MTX 20 mg/m2/week IM
Reinductions
VCR: 1,5 mg/m2 IV, day 1.
PDN: 60 mg/m2/day, IV or PO days 1 to 7
L-ASA: 20.000 UI/m2, IM or IV day 1.
Intrathecally day 1

Seven cycles, weeks 25, 29, 33, 37, 41, 45 and 49.

Maintenance therapy 2:administration of continuous chemotherapy (mercaptopurine and methotrexate) while second year from diagnosis (weeks 53 to 104).

MP 50 mg/m2/day, PO
MTX 20 mg/m2/week, IM.

Study Design

Study Type:

Interventional

Actual Enrollment :

374 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PETHEMA LAL-RI/96: Treatment for Patients With Standard Risk Acute Lymphoblastic Leukemia

Study Start Date :

Jun 1, 1996

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Efficacy of treatment in adults with standard risk acute lymphoblastic leukemia [2 years]

Secondary Outcome Measures

Demonstrate that in this group of patients, the CNS relapse is not frequently and is not necessary cranial radiotherapy [2 years]
To evaluate the treatment tolerance [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults (over 15 years) with ALL standard risk no prior antiblastic chemotherapy

Exclusion Criteria:

Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
Mixed forms of ALL
Acute Leukemia no differentiate
Patients with coronary disorders, valvular or hypertensive cardiopathy
Patients with chronic liver disorders
Chronic pulmonary disorders
Renal insufficiency
Neurologic disfunctions
ECOG 3 and 4
No signed consent form

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital Central de Asturias	Oviedo	Asturias	Spain
2	Hospital Germans Trias i Pujol	Badalona	Barcelona	Spain
3	Corporació Sanitària Parc Taulí	Sabadell	Barcelona	Spain
4	Hospital Mútua de Terrassa	Terrassa	Barcelona	Spain
5	Hospital general de Castellón	Castello	Castellón	Spain
6	Hospital Verge de la Cinta	Tortosa	Tarragona	Spain
7	Complejo Hospitalario Universitario de Albacete	Albacete		Spain
8	Hospital General de Alicante	Alicante		Spain
9	Hospital Ntra. Sra. Sonsoles	Avila		Spain
10	Hospital Regional Universitario Infanta Cristina	Badajoz		Spain
11	Hospital Clínic	Barcelona		Spain
12	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain
13	Hospital del Mar	Barcelona		Spain
14	Hospital vall d'Hebrón	Barcelona		Spain
15	Hospital Valle Hebrón-Materno Infantil	Barcelona		Spain
16	Basurtuko Ospitalea	Basurto		Spain
17	Hospital Nuestra Señora de Alarcos	Ciudad Real		Spain
18	Hospital Virgen de la Luz	Cuenca		Spain
19	Complejo Hospitalario de Cáceres	Cáceres		Spain
20	Hospital Puerta del Mar	Cádiz		Spain
21	Complejo Hospitalario Reina Sofía	Córdoba		Spain
22	Hospital General de Elda	Elda		Spain
23	Institut Català d'Oncologia,	Gerona		Spain
24	Hospital Universitario Virgen de las Nieves	Granada		Spain
25	Hospital Juan Ramón Jiménez	Huelva		Spain
26	Hospital de San Jorge	Huesca		Spain
27	Hospital Médico Quirúrgico Ciudad de Jaén	Jaen		Spain
28	Hospital de Jerez de la Frontera	Jerez de la Frontera		Spain
29	Hospital Juan Canalejo	La Coruña		Spain
30	Hospital General de Lanzarote	Lanzarote		Spain
31	Complejo Hospitalario León	Leon		Spain
32	Hospital Arnau de Vilanova	Lleida		Spain
33	Complexo Hospitalario Xeral-Calde	Lugo		Spain
34	Clínica Puerta de Hierro	Madrid		Spain
35	Hospital 12 de Octubre	Madrid		Spain
36	Hospital Clínico San Carlos de Madrid	Madrid		Spain
37	Hospital de Fuenlabrada	Madrid		Spain
38	Hospital de la Princesa	Madrid		Spain
39	Hospital Doce de Octubre	Madrid		Spain
40	Hospital General Universitario Gregorio Marañón, Madrid	Madrid		Spain
41	Hospital Puerta de Hierro	Madrid		Spain
42	Hospital Ramón y Cajal	Madrid		Spain
43	Hospital Universitario de la Princesa	Madrid		Spain
44	Hospital Universitario La Paz	Madrid		Spain
45	Hospital Universitario Princcipe de Asturias	Madrid		Spain
46	Althaia, Xarxa Asistencial de Manresa	Manresa		Spain
47	Hospital General Morales Meseguer	Murcia		Spain
48	Hospital Santa María del Rosell	Murcia		Spain
49	Hospital Virgen del Castillo de Yecla	Murcia		Spain
50	. Hospital Clínico Universitario Virgen de la Victoria	Málaga		Spain
51	H. Carlos Haya	Málaga		Spain
52	Hospital del Río Carrión	Palencia		Spain
53	Complejo Asistencial Son Dureta	Palma de Mallorca		Spain
54	Hospital Son Dureta	Palma de Mallorca		Spain
55	Hospital Son Llatzer	Palma de Mallorca		Spain
56	Hospital Verge del Toro	Palma de Mallorca		Spain
57	Clínica Universitaria de Navarra	Pamplona		Spain
58	Hospital Virgen del Camino	Pamplona		Spain
59	Complejo Hospitalario de Pontevedra_Hospital Montecelo	Pontevedra		Spain
60	Hospital de Sagunto	Sagunto		Spain
61	Hospital Clínico de Salamanca	Salamanca		Spain
62	Hospital San Pedro de Alcántara	San Pedro de Alcántara		Spain
63	Clínica Sant Camil	Sant Pere de Ribes		Spain
64	Hospital Universitario Marqués de Valdecilla	Santander		Spain
65	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela		Spain
66	Hospital de Santiago de Compostela	Santiago de Compostela		Spain
67	Hospital General de Segovia	Segovia		Spain
68	H.U. Virgen del Rocio	Sevilla		Spain
69	Hospital Universitario Virgen del Rocío	Sevilla		Spain
70	Hospital Joan XXIII	Tarragona		Spain
71	Hospital Universitario de Canarias	Tenerife		Spain
72	Hospital Nuestra Señora del Prado	Toledo		Spain
73	Hospital Virgen de la Salud	Toledo		Spain
74	Fundación Instituto Valenciano de Oncología	Valencia		Spain
75	Hospital Clínico Universitario de Valencia	Valencia		Spain
76	Hospital Clínic	Valencia		Spain
77	Hospital Dr. Peset	Valencia		Spain
78	Hospital Francesc de Borja	Valencia		Spain
79	Hospital General Básico de la Defensa	Valencia		Spain
80	Hospital General Universitario	Valencia		Spain
81	Hospital La Fe	Valencia		Spain
82	Hospital Clínico de Valladolid	Valladolid		Spain
83	Complejo Hospitalario Universitario de Vigo	Vigo		Spain
84	Hospital Meixoeiro	Vigo		Spain
85	Hospital Txagorritxu	Vitoria		Spain
86	Hospital de Galdakao	Vizcaya		Spain
87	Hospital Clínico Lozano Blesa	Zaragoza		Spain