NCT03156790 - PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 26, 2019

Primary Completion Date

April 29, 2025

Study Completion Date

May 31, 2026

Conditions

Acute B-Cell Lymphoblastic Leukaemia

Interventions

DRUG

Spectrila®

3 intravenous doses of 10 000 U/m² BSA each during induction phase I of the underlying BRALL 2014 treatment protocol on Days 21, 23 and 25. Additionally, the subjects (standard risk subjects only) will receive doses of 10 000 U/m² BSA each on Days 2, 4, 6, 9, 11 and 13 of the consolidation phase II, III and VI of BRALL 2014 treatment protocol.

Trial Locations (8)

30130-100

Hospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte

13083-878

Universidade Estadual de Campinas, Campinas

74605-020

Hospital das Clínicas da UFG, Goiânia

59020-100

Hospital Rio Grande Natal, Natal

90035-903

Hospital de Clínicas Porto Alegre, Pôrto Alegre

14048-900

Hospital das Clínicas São Paulo USP, Ribeirão Preto

20231-048

INCA Instituto Nacional do Cancer, Rio de Janeiro

09190 615

Hospital Estadual Mario Covas, Santo André