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Acute B-Cell Lymphoblastic LeukaemiaPhase 2NCT03156790

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

A Phase 2 study testing Spectrila® in people with Acute B-Cell Lymphoblastic Leukaemia, run by medac GmbH at 8 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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®). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Acute B-Cell Lymphoblastic Leukaemia
What is being tested?
Spectrila®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
8 sitesBrazil
Study dates
26 Apr 2019to 19 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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.
  • The subject is imprisoned or is lawfully kept in an institution.
  • The subject has participated within 3 months before screening or plans to participate in a clinical trial (except the underlying treatment protocol BRALL 2014).
  • Previous participation in this clinical trial -

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Brazil8 sites

  • Hospital das Clínicas da Universidade Federal de Minas Gerais

    Belo Horizonte, 30130-100

  • Universidade Estadual de Campinas

    Campinas, 13083-878

  • Hospital das Clínicas da UFG

    Goiânia, 74605-020

  • Hospital Rio Grande Natal

    Natal, 59020-100

  • Hospital de Clínicas Porto Alegre

    Pôrto Alegre, 90035-903

  • Hospital das Clínicas São Paulo USP

    Ribeirão Preto, 14048-900

  • INCA Instituto Nacional do Cancer

    Rio de Janeiro, 20231-048

  • Hospital Estadual Mario Covas

    Santo André, 09190 615

Other trials in Brazil

About this study

Official title: A Clinical Phase II Trial to Describe Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Spectrila® With the Pharmaceutical Active Ingredient Recombinant L-Asparaginase in Adult Subjects With Newly Diagnosed Acute B-Cell Lymphoblastic Leukaemia

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.

Read the detailed description

The BRALL (Brazilian Acute Lymphocytic Leukaemia) treatment protocol was developed to standardise adult ALL treatment in Brazil since previously each centre used a different protocol. As in other treatment regimens of study groups, ASNase is an important component of ALL therapy. The rationale of the BRALL protocol was to use less myelotoxic drugs as daunorubicin, etoposide and cyclophosphamide and focus on more specific ALL directed therapies as asparaginase and methotrexate. The higher asparaginase dose regimen was chosen in BRALL 2014 to strengthen ASNase as major component of the treatment protocol while etoposide administration is reduced. Native ASNase is widely used and the data investigating non-inferiority, safety and tolerability of Asparaginase medac vs. Spectrila received a positive opinion from the European Medicines Agency (EMA). Nevertheless, data on efficacy and safety of Spectrila in adults are limited. Therefore, robust data on PK, pharmacodynamics (PD), safety and immunogenicity of Spectrila will be investigated in this trial in subjects with de novo ALL. The measurement of ASNase activity is considered to correlate with clinical effectiveness and therefore chosen as primary objective.

Subjects eligible for participation in this clinical trial will be treated with 3 intravenous doses of Spectrila of 10 000 U/m² BSA each during induction phase I of the underlying BRALL 2014 treatment protocol. Spectrila will be administered on Days 21, 23 and 25. Additionally, the subjects (standard risk subjects only) will receive doses of 10 000 U/m² BSA Spectrila each on Days 2, 4, 6, 9, 11 and 13 of the consolidation phase II, III and VI of BRALL 2014 treatment protocol. One final Analysis is planned.

Being tested
Spectrila®
Keywords
recombinant L-Asparaginase, Spectrila®, Lymphoblastic Leukaemia, BRALL 2014
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spectrila®Drug

    Also called recombinant L-Asparaginase

    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.

Study groups in NCT03156790
Study groupRoleWhat they receive
Spectrila®Experimentalrecombinant L-Asparaginase
Receives: Drug: Spectrila®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 21 until Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2017
  2. Study start26 Apr 2019
  3. Primary completion16 Nov 2025
  4. Study completion19 Dec 2025

Why it stopped: Early termination

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03156790
Sponsor's protocol ID
MC-Spectrila.1/ALL
Status last verified
Mar 2026
First submitted
15 May 2017
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Spectrila® in people with Acute B-Cell Lymphoblastic Leukaemia, run by medac GmbH at 8 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Early termination). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asparaginase (ASNase) activity trough levels (time frame: Day 21 until Day 31). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03156790.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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