Tezepelumab for chronic bronchial disease due to BOS after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates the safety and potential efficacy of tezepelumab in adults with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic stem cell transplantation. Eligible participants have a fixed obstructive ventilatory defect consistent with BOS and a history of bronchial exacerbations despite inhaled therapy. The study aims to determine whether blocking TSLP with tezepelumab can improve lung function and reduce exacerbations in this high-risk population. Enrollment is limited to sites in Besançon, Bordeaux, and Caen, France. Participants continue standard inhaled therapies and systemic immunosuppression as part of routine care while receiving the study treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult recipients, minimum age 18
2. Recipient of an allogeneic bone marrow or haematopoietic stem cell transplant
3. At more than 3 years after the date of the transplantation
4. BOS defined by the occurrence of a new fixed obstructive ventilatory disorder after the allograft (accepted criteria: FEV1/FVC ≤70% and FEV1 \< 75% pred value and decline of more than 10% over less than 2 years OR FEV1/FVC \> 70% and FEV1 \< 75% pred value and decline of FEV1 more than 10% over less than 2 years and Normal TLC \> 80% OR decline of FEV1 more than 10% over less than 2 years and TLC \> 120% and/or RV/TLC \> 40%)
5. Presenting an exacerbation profile: 2 or more moderate to severe bronchial exacerbations in the previous 12 months
6. On optimal inhaled therapy comprising at least one long-acting bronchodilator and one inhaled corticosteroid for at least three months.
7. Stable dose of systemic immunosuppressive regimen for the last 4 weeks
8. Being covered by a national health insurance
9. Signed consent form

Exclusion Criteria:

1. Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH
2. FEV1\< 20% theorical value
3. Being deprived of liberty or under guardianship
4. Absence of signed consent
5. Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE
6. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy
7. Respiratory infection in the course of treatement (including acute bacterial and viral infection, long term treatment for fungal or non-tuberculosis mycobacteria)
8. History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy
9. Severe GVHD scleroderma-like manifestations of skin making subcutaneous injections of the investigational treatment impossible or overly difficult
10. Pregnant, breastfeeding or lactating women

Where it's running

• Foch Hospital
  Suresnes, France Recruiting
• CHU de Besançon
  Besançon, France Not yet recruiting
• Hôpital Haut-Lévêque - CHU Bordeaux
  Bordeaux, France Not yet recruiting
• CHU Caen Normandie
  Caen, France Not yet recruiting
• CHRU de Lille
  Lille, France Not yet recruiting
• Hôpital Saint-Louis APHP
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Yahya DEBZA
• Email: y.debza@hopital-foch.com
• Phone: +33 1 46 25 36 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.