LAL-BR/2001: Study Treatment to Low Risk ALL

Sponsor

PETHEMA Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT00526175

Collaborator

(none)

150

Enrollment

Locations

174

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia	Drug: Prednisone Drug: Vincristine Drug: Daunorubicin Drug: L-Asparaginase Drug: Cyclophosphamide Drug: Methotrexate Drug: Cytosine Arabinoside Drug: Mercaptopurine Drug: VP-16	Phase 4

Detailed Description

REMISION INDUCTION

Systemic chemotherapy:

Prednisolone (PDN):

60 mg/m2 day, i.v. or p.o., days 1 to 27
30 mg/m2 day, i.v. or p.o., days 28 to 35

Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.

Cyclophosphamide (CFM): 1000 mg/m2, i.v., day 22.

Intracranial chemotherapy

Methotrexate (MTX), cytosine (ARA-C) and hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT (WEEKS 6 TO 14)with INTENSIFICACIÓN (C-1)

Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
MTX: 3g/m2, i.v., in 24 hours, days 1, 28 and 56.
VP-16: 150 mg/m2 i.v., days 14-15 and 42-43
ARA-C: 1000 mg/m2 i.v., in 3 hours, days 14-15 and 42-43
Intrathecal treatment, days 1, 28 and 56.

REINDUCTION-CONSOLIDATION TREATMENT (R-C) (WEEKS 15 TO 23)

Dexamethasone (DXM):

6 mg/m2 day, p.o., days 1-21
3 mg/m2 day, p.o. or i.v., days 22-28 VCR: 1,5 mg/m2, i.v., days 1, 8 and 15 DNR: 30 mg/m2, i.v., days 1 and 8 L-ASA: 10.000 UI/m2 i.m. or i.v., days 8 and 9, 15 and 16, 22 and 23. CFM 1000 mg/m2 day, i.v., day 22 Mercaptopurine (MP) 50 mg/m2, p.o., days 35-42 MTX: 3g/m2, i.v., in 24 hours, day 35. VP-16: 150 mg/m2 i.v., days 49-50 ARA-C: 1.000 mg/m2 i.v., in 3 hours, days 49-50 Intrathecal treatment days 1 and 35.

MAINTENANCE TREATMENT (M-1)

Continuous treatment

MP 50 mg/m2/day, p.o.
MTX 20 mg/m2/week, i.m.

Reinductions

VCR: 1,5 mg/m2 i.v., day 1.
PDN: 30 mg/m2/day, i.v. or p.o., days 1 to 7
L-ASA: 20.000 UI/m2, i.m. or i.v., day 1.
Intrathecal treatment day 1 Five cycles, weeks 24, 30, 36, 42 and 48. During the week of administration cycle, continuous chemotherapy should be suspended.

Intrathecal treatment: At the start of any reinduction cycle

MAINTENANCE TREATMENT (M-2) (WEEKS 55-108)

MP 50 mg/m2/day, p.o.
MTX 20 mg/m2/week, i.m.
Intrathecal treatment, weeks 54 and 108

At the end of treatment should be done the study of MRD (flux cytometry)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

LAL-BR/2001: Study Treatment to Low Risk ALL

Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously

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	Country
1	Complejo Hospitalario Universitario de Albacete	Albacete	Spain
2	Hospital General de Alicante	Alicante	Spain
3	Hospital de Badalona Germans Trias i Pujol	Badalona	Spain
4	Hospital de Sant Pau	Barcelona	Spain
5	Hospital del Mar	Barcelona	Spain
6	Hospital Valle Hebrón-Materno Infantil	Barcelona	Spain
7	Basurtuko Ospitalea	Basurto	Spain
8	Complejo Hospitalario Reina Sofía	Córdoba	Spain
9	Hospital General de Guadalajara	Guadalajara	Spain
10	Complejo Hospitalario León	Leon	Spain
11	Hospital Clínico San Carlos de Madrid	Madrid	Spain
12	. Hospital Clínico Universitario Virgen de la Victoria	Málaga	Spain
13	Complejo Asistencial Son Dureta	Palma de Mallorca	Spain
14	Hospital Clinico Universitario	Salamanca	Spain
15	Hospital Clínico Universitario de Salamanca	Salamanca	Spain
16	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	Spain
17	Hospital General de Segovia	Segovia	Spain
18	H.U. Virgen del Rocio	Sevilla	Spain
19	Hospital Joan XXIII	Tarragona	Spain
20	Hospital Arnau de Vilanova	Valencia	Spain
21	Hospital Clínic	Valencia	Spain
22	Hospital La Fe	Valencia	Spain
23	Hospital Universitario Dr. Peset	Valencia	Spain
24	Hospital Clínico de Valladolid	Valladolid	Spain
25	Hospital Clínico Lozano Blesa	Zaragoza	Spain