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

NCT ID: NCT00526175

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2015-12-31

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)

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Prednisone

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

Intervention Type: DRUG

Vincristine

1,5 mg/m2 i.v., days 8, 15, 22 and 28

Intervention Type: DRUG

Daunorubicin

30 mg/m2, i.v., days 8 and 15

Intervention Type: DRUG

L-Asparaginase

10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25. Total: 9 doses.

Intervention Type: DRUG

Cyclophosphamide

1000 mg/m2, i.v., day 22.

Intervention Type: DRUG

Methotrexate

Age \<1 year 1-2 years 2-3 years \> 3 years MTX 5 mg 8 mg 10 mg 12 mg

Intervention Type: DRUG

Cytosine Arabinoside

Edad \<1 year 1-2 years 2-3 years \> 3 years ARA-C 16 mg 16 mg 20 mg 30 mg

Intervention Type: DRUG

Mercaptopurine

50 mg/m2,oral, days 1 to 7, 28-35 and 56-63

Intervention Type: DRUG

VP-16

150 mg/m2 i.v., days 14-15 and 42-43

Intervention Type: DRUG

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

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PETHEMA Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ribera Josep Mª, Dr

Role: STUDY_CHAIR

Germans Trias i Pujol Hospital

Bastida Pilar, Dr

Role: STUDY_CHAIR

Hospital Materno-Infantil Vall d'Hebron

Locations

Hospital General de Alicante

Alicante, Alicante, Spain

Hospital Valle Hebrón-Materno Infantil

Barcelona, Barcelona, Spain

Complejo Hospitalario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

. Hospital Clínico Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Hospital Joan XXIII

Tarragona, Tarragona, Spain

Hospital Clínic

Valencia, Valencia, Spain

Hospital La Fe

Valencia, Valencia, Spain

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Hospital de Badalona Germans Trias i Pujol

Badalona, , Spain

Hospital de Sant Pau

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Basurtuko Ospitalea

Basurto, , Spain

Hospital General de Guadalajara

Guadalajara, , Spain

Complejo Hospitalario León

León, , Spain

Complejo Asistencial Son Dureta

Palma de Mallorca, , Spain

Hospital Clinico Universitario

Salamanca, , Spain

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Hospital General de Segovia

Segovia, , Spain

H.U. Virgen del Rocio

Seville, , Spain

Hospital Arnau de Vilanova

Valencia, , Spain

Hospital Clínico de Valladolid

Valladolid, , Spain

Countries

Spain

Related Links

http://www.aehh.org

Spanish association of Haematology

Other Identifiers

LAL-BR/2001

Identifier Type: -

Identifier Source: org_study_id