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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526175
• Other study ID #: LAL-BR/2001
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2007
• Last updated: January 16, 2016
• Start date: June 2001
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• 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
• Vincristine
1,5 mg/m2 i.v., days 8, 15, 22 and 28
• Daunorubicin
30 mg/m2, i.v., days 8 and 15
• 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.
• Cyclophosphamide
1000 mg/m2, i.v., day 22.
• Methotrexate
Age <1 year 1-2 years 2-3 years > 3 years MTX 5 mg 8 mg 10 mg 12 mg
• Cytosine Arabinoside
Edad <1 year 1-2 years 2-3 years > 3 years ARA-C 16 mg 16 mg 20 mg 30 mg
• Mercaptopurine
50 mg/m2,oral, days 1 to 7, 28-35 and 56-63
• VP-16
150 mg/m2 i.v., days 14-15 and 42-43

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital General de Alicante	Alicante
Spain	Hospital de Badalona Germans Trias i Pujol	Badalona
Spain	Hospital de Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Valle Hebrón-Materno Infantil	Barcelona
Spain	Basurtuko Ospitalea	Basurto
Spain	Complejo Hospitalario Reina Sofía	Córdoba
Spain	Hospital General de Guadalajara	Guadalajara
Spain	Complejo Hospitalario León	Leon
Spain	Hospital Clínico San Carlos de Madrid	Madrid
Spain	. Hospital Clínico Universitario Virgen de la Victoria	Málaga
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	Sevilla
Spain	Hospital Joan XXIII	Tarragona
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clínic	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival		2 years	No

External Links

•   Pethema Foundation web
•   Spanish association of Haematology