Clinical trial NCT00526175: LAL-BR/2001: Study Treatment to Low Risk ALL
Official title: LAL-BR/2001: Study Treatment to Low Risk ALL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Minimal Residual Disease
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 150
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Badalona
country: Spain
facility: Hospital de Badalona Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Valle Hebrón-Materno Infantil
city: Basurto
country: Spain
facility: Basurtuko Ospitalea
city: Córdoba
country: Spain
facility: Complejo Hospitalario Reina Sofía
city: Guadalajara
country: Spain
facility: Hospital General de Guadalajara
city: Leon
country: Spain
facility: Complejo Hospitalario León
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Málaga
country: Spain
facility: . Hospital Clínico Universitario Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Complejo Asistencial Son Dureta
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: H.U. Virgen del Rocio
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Clínic
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Ribera Josep Mª, Dr
role: STUDY_CHAIR
affiliation: Hospital Materno-Infantil Vall d'Hebron
name: Bastida Pilar, Dr
role: STUDY_CHAIR
References: