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

NCT03156790 | Terminated Phase 2

• 1 other identifier: MC-Spectrila.1/ALL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD, immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant ASNase (Spectrila®). Since Spectrila is already approved in the European Economic Area for first-line treatment of ALL patients of all age groups and showed similar efficacy and safety in comparison to Asparaginase medac no blinding or control groups are necessary. As underlying treatment protocol the BRALL 2014 treatment protocol will be used.

Conditions

Acute B-Cell Lymphoblastic Leukaemia

Keywords

recombinant L-Asparaginase; Spectrila®; Lymphoblastic Leukaemia; BRALL 2014

Outcome Measures

Primary Outcomes (1)

• Asparaginase (ASNase) activity trough levels

  Assessment of induction phase response, defined as subjects with asparaginase (ASNase) activity trough levels in serum ≥ 100 U/L in induction phase

  Day 21 until Day 31

Study Arms (1)

Spectrila®

EXPERIMENTAL

recombinant L-Asparaginase

Drug: Spectrila®

Interventions

Spectrila® DRUG

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.

Also known as: recombinant L-Asparaginase

Spectrila®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with newly diagnosed pathologically confirmed acute B-cell lymphoblastic leukaemia
• Female or male subjects between 18 and 55 years of age (inclusive)
• Subjects eligible for treatment and treated according to the underlying treatment protocol BRALL 2014
• Written informed consent given freely after the nature of the trial and disclosure of data has been explained to the subject
• The subject shows no evidence of a current infection with SARS-CoV-2 (as diagnosed by thorax tomography or PCR test or test for anti-SARS-CoV-2 antibodies).
• The subject expresses his/her understanding of the trial procedures and willingness to abide by them during the course of the trial
• Female subjects of child-bearing potential must use a highly effective method of contraception (pearl index less than 1%) such as complete sexual abstinence, combined oral contraceptive, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap/diaphragm with spermicide during the trial and for at least 7 months after Spectrila discontinuation.
• Men should use effective contraceptive measures and be advised to not father a child while receiving ASNase. As a precautionary measure it is recommended to wait at least for 4 months after completion of treatment.

You may not qualify if:

• Pre-treatment with any ASNase preparation
• Hypersensitivity to the active substance, Escherichia coli- ASNase preparation or to any of the excipients
• Pancreatitis at the time of treatment initiation or history of pancreatitis
• Pre-existing known coagulopathy
• Severe liver function impairment (bilirubin \> three times the upper limit of normal \[ULN\]; transaminases \> ten times ULN)
• History of serious haemorrhage or serious thrombosis
• Other current malignancies
• Uncontrolled active infection
• Evidence of infection with severe acute respiratory syndrome coronavirus typ 2 (SARS-CoV-2), the human immunodeficiency virus, hepatitis B or C, human T-lymphotropic virus type I and II, syphilis or Chagas disease (American trypanosomiasis)
• Pregnancy as verified by a positive pregnancy test or nursing woman
• Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely
• Evidence or suspicion that the subject might not comply with the requirements of the trial protocol.
• Evidence or suspicion that the subject is unwilling or unable to understand the information given to him/her within the informed consent procedure
• Any other factor which in the investigator's opinion is likely to compromise the subject's ability to participate in the trial
• The subject is an employee or direct relative of an employee of the contract research organisation (CRO) involved in the trial, the trial site or medac.

Sponsors & Collaborators

• medac GmbH: lead
• Syneos Health: collaborator

Study Sites (8)

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, 30130-100, Brazil

Location

Universidade Estadual de Campinas

Campinas, 13083-878, Brazil

Location

Hospital das Clínicas da UFG

Goiânia, 74605-020, Brazil

Location

Hospital Rio Grande Natal

Natal, 59020-100, Brazil

Location

Hospital de Clínicas Porto Alegre

Pôrto Alegre, 90035-903, Brazil

Location

Hospital das Clínicas São Paulo USP

Ribeirão Preto, 14048-900, Brazil

Location

INCA Instituto Nacional do Cancer

Rio de Janeiro, 20231-048, Brazil

Location

Hospital Estadual Mario Covas

Santo André, 09190 615, Brazil

Location

Related Links

• Sponsor's homepage

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Belinda Simoes, MD

  Ribeirão Medical School Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: April 26, 2019
• Primary Completion: November 16, 2025
• Study Completion: December 19, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (8)