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NCT07313943: HL PAX5- 2025
PAX5-NEGATIVE HODGKIN-LIKE LYMPHOMAS: A DIAGNOSTIC CHALLANGE
trial in Hodgkin or Non-Hodgkin Lymphoma in 60 participants. Currently enrolling.
28 February 2026
Quick facts
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 30 December 2025 |
| Primary completion | 28 February 2026 |
| Estimated completion | 30 December 2027 |
| Sites | 2 locations across Italy, Germany |
Conditions studied
- Hodgkin or Non-Hodgkin Lymphoma — all drugs for Hodgkin or Non-Hodgkin Lymphoma →
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →
Who can join
18 and older, any sex, with Hodgkin or Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hodgkin lymphoma (HL) is a lymphoma that arises from peripheral B lymphocytes. However, the neoplastic cells, Hodgkin cells and Reed-Sternberg cells, typically lack most B-cell markers, usually preserving the expression of the transcriptional factor PAX5, only phenotypic clue of B-cell origin. Morphologically similar cells to those diagnostic Hodgkin and Reed-Sternberg cells can also be observed in other lymphocytic proliferations, including Anaplastic Large Cell Lymphoma (ALCL), which originates from T lymphocytes and which share many features with HL, like strong CD30 expression and usually loss of T-cell markers. However, their clinical course is dramatically different with curability rates of \>90% for classical HL and an unfavorable prognosis for ALCL. PAX5 expression in HL and cytotoxic molecules expression in ALCL tumor cells may be a useful aid for diagnosis. However, in some cases the differential diagnosis is difficult owing to absence of these established markers. Furthermore, clonality analyses on classical HL were focused on Ig regions while TCR clonality has not yet been usefully explored. Studying the TCR clonal status of tumor cells, correlating it with a more comprehensive immunophenotypic profile and investigating the presence or absence of characteristic rearrangements (such as the JAK2 rearrangement, typical of ALCL lymphomas) could help to resolve the immuno-morphological overlap of the two entities and identify a possible repetitive pattern based on morphological, phenotypic and genetic characteristics. To this aim we intend to involve the Pathological Anatomy of Tubinga to increase the number of cases and achieve statistical significance, given the relative rarity of this entity
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT07313943
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07313943 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Last refreshed: 2 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07313943.
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