Acute B-Cell Lymphoblastic Leukaemia Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | May 2026 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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 3 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 3 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 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 - |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital das Clínicas da Universidade Federal de Minas Gerais | Belo Horizonte | |
| Brazil | Universidade Estadual de Campinas | Campinas | |
| Brazil | Hospital das Clínicas da UFG | Goiânia | |
| Brazil | Hospital de Clínicas Porto Alegre | Pôrto Alegre | |
| Brazil | Hospital das Clínicas São Paulo USP | Ribeirão Preto | |
| Brazil | INCA Instituto Nacional do Cancer | Rio de Janeiro | |
| Brazil | Hospital Estadual Mario Covas | Santo André | |
| Brazil | Hospital de Base de Sáo José | São José |
| Lead Sponsor | Collaborator |
|---|---|
| medac GmbH | Syneos Health |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |