Evaluating Spectrila for treating adults with Acute B-cell Lymphoblastic Leukaemia
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 study is testing a new treatment called Spectrila to see if it can safely help adults with Acute B-cell Lymphoblastic Leukaemia during their initial treatment phase.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | medac GmbH Industry-sponsored |
| Drugs / interventions | methotrexate, cyclophosphamide |
| Locations | 9 sites (Belo Horizonte and 8 other locations) |
| Trial ID | NCT03156790 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a non-controlled, single-arm, open-label investigation focusing on the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of Spectrila in adults diagnosed with Acute B-cell Lymphoblastic Leukaemia (ALL). Participants will receive three intravenous doses of Spectrila during the induction phase of the BRALL 2014 treatment protocol. The study aims to gather robust data on the efficacy and safety of Spectrila, which has shown promise in previous studies but lacks extensive data in adult populations. The trial will measure ASNase activity as a primary objective, correlating it with clinical effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with newly diagnosed, pathologically confirmed Acute B-cell Lymphoblastic Leukaemia.
Not a fit: Patients with pre-existing infections or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a more effective treatment option for adults with Acute B-cell Lymphoblastic Leukaemia.
How similar studies have performed: Previous studies have shown positive outcomes with similar approaches, but this specific investigation into Spectrila's efficacy in adults is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects with newly diagnosed pathologically confirmed acute B-cell lymphoblastic leukaemia 2. Female or male subjects between 18 and 55 years of age (inclusive) 3. Subjects eligible for treatment and treated according to the underlying treatment protocol BRALL 2014 4. Written informed consent given freely after the nature of the trial and disclosure of data has been explained to the subject 5. 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). 6. The subject expresses his/her understanding of the trial procedures and willingness to abide by them during the course of the trial 7. 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. 8. 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. Exclusion Criteria: 1. Pre-treatment with any ASNase preparation 2. Hypersensitivity to the active substance, Escherichia coli- ASNase preparation or to any of the excipients 3. Pancreatitis at the time of treatment initiation or history of pancreatitis 4. Pre-existing known coagulopathy 5. Severe liver function impairment (bilirubin \> three times the upper limit of normal \[ULN\]; transaminases \> ten times ULN) 6. History of serious haemorrhage or serious thrombosis 7. Other current malignancies 8. Uncontrolled active infection 9. 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) 10. Pregnancy as verified by a positive pregnancy test or nursing woman 11. Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely 12. Evidence or suspicion that the subject might not comply with the requirements of the trial protocol. 13. Evidence or suspicion that the subject is unwilling or unable to understand the information given to him/her within the informed consent procedure 14. Any other factor which in the investigator's opinion is likely to compromise the subject's ability to participate in the trial 15. 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. 16. The subject is imprisoned or is lawfully kept in an institution. 17. The subject has participated within 3 months before screening or plans to participate in a clinical trial (except the underlying treatment protocol BRALL 2014). 18. Previous participation in this clinical trial -
Where this trial is running
Belo Horizonte and 8 other locations
- Hospital das Clínicas da Universidade Federal de Minas Gerais — Belo Horizonte, Brazil (Completed)
- Universidade Estadual de Campinas — Campinas, Brazil (Recruiting)
- Hospital das Clínicas da UFG — Goiânia, Brazil (Recruiting)
- Hospital de Clínicas Porto Alegre — Pôrto Alegre, Brazil (Completed)
- Hospital das Clínicas São Paulo USP — Ribeirão Preto, Brazil (Recruiting)
- INCA Instituto Nacional do Cancer — Rio de Janeiro, Brazil (Recruiting)
- Hospital Rio Grande Natal — Rio Grande do Norte, Brazil (Recruiting)
- Hospital Estadual Mario Covas — Santo André, Brazil (Completed)
- Hospital de Base de Sáo José — São José, Brazil (Withdrawn)
Study contacts
- Principal investigator: Belinda Simoes, MD — Ribeirão Medical School Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto
- Study coordinator: Belinda Simoes, MD
- Email: bpsimoes@fmrp.usp.br
- Phone: 55 16 36022663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.