Current clinical trials: one first-line option in Skåne, nothing for watch-and-wait¶
Registries [E]. The trial information below draws on three registries, as of 7 October 2026: ClinicalTrials.gov, the EU's CTIS and RCC's Cancerstudier i Sverige. No single registry gives a correct picture:
- ClinicalTrials.gov has no record of CLL18, and it still shows two closed trials as recruiting.
- RCC misses HOVON 180, and it may mislabel CaDAnCe-101 as ended.
17.1 Trials relevant to a newly diagnosed patient¶
| Trial | IDs | Phase / design | Intervention | Inclusion concept | Recruiting centres | Why it might or might not matter |
|---|---|---|---|---|---|---|
| CLL18/MOIRAI (sponsor: University of Cologne/GCLLSG; Swedish coordination: Akademiska) | EU CT 2023-510294-34-00; no NCT number | Phase 3, randomised 1:1:1, open-label; 813 planned | Venetoclax-obinutuzumab, fixed 12 cycles (standard arm) vs venetoclax + pirtobrutinib, fixed 15 cycles vs venetoclax + pirtobrutinib, MRD-guided 15–36 cycles. All arms time-limited | Untreated CLL/SLL requiring treatment by iwCLL. Needs CLL-phenotype cells above 10⁻² trackable by flow cytometry; CrCl ≥30; no single organ scored 4 on the CIRS comorbidity scale; no Richter; no warfarin. TP53-aberrant and SLL patients included (both are stratification factors). No upper age limit. The ECOG threshold is missing from the public text | Sweden: Skånes universitetssjukhus Lund (contact Oscar Lindblad), Umeå, Sahlgrenska, Örebro, Linköping, Halmstad, Uppsala, Falun. Recruiting since 23 Sep 2025; 40 Swedish patients planned. Denmark: Rigshospitalet, Køge, Odense, Vejle, Aarhus | Relevant only if treatment becomes indicated. The only first-line trial with a Skåne site, and every arm is time-limited. GCLLSG plans to close recruitment in Q1 2027. [I] Nodal SLL with few circulating cells might fail the flow-cytometry criterion. Whether Lund has open slots today must be checked with the clinic |
| BELLWAVE-011 (MSD) | NCT06136559; EU CT 2022-501697-19-01 | Phase 3, randomised; 1,200 planned | Nemtabrutinib (a new reversible BTK inhibitor) vs the investigator's choice of ibrutinib or acalabrutinib. Both arms continuous | Untreated CLL or SLL with active disease; ECOG 0–2; excludes Richter, significant heart disease and gut malabsorption | Sweden: Karolinska Solna only (28 planned). Denmark: Roskilde, Odense, Aalborg | Relevant only if treatment is indicated and continuous BTKi therapy is acceptable. The nearest site is Stockholm or Roskilde |
| BGB-11417-304 (BeOne) | NCT07277231; EU CT 2025-524366-21-00 | Phase 3, randomised, open-label; 500 planned | Sonrotoclax + zanubrutinib vs acalabrutinib + venetoclax (both fixed duration) | Untreated CLL: clonal B cells ≥5×10⁹/L in blood at some point since diagnosis, no t(11;14); iwCLL indication; ECOG 0–2; measurable disease on CT/MRI; no warfarin | Sweden: Karolinska Solna only, recruiting since 24 Jun 2026; only 5 Swedish patients planned. No Danish site | Relevant only if treatment is indicated and the disease meets the blood definition of CLL. [I] Probably not open to pure SLL. Slots are few |
| Closed: PreVent-ACaLL (sponsor: Rigshospitalet) | NCT03868722; EU CT 2024-511072-33-00 | Phase 2 (CTIS) or 2/3 (ClinicalTrials.gov) | Short course of acalabrutinib + venetoclax vs observation | Newly diagnosed, high risk of infection or early treatment on the CLL-TIM model, no iwCLL indication | Recruitment ended in Sweden (8 Nov 2024) and Denmark (19 Jun 2025) | The only watch-and-wait trial found, and no longer an option. Listed because the stale ClinicalTrials.gov entry still says "recruiting" |
| For reference: EVOLVE (SWOG S1925) | NCT04269902 | Phase 3 | Early vs delayed venetoclax-obinutuzumab | Asymptomatic high risk: CLL-IPI ≥4 or complex karyotype | US trial; no Swedish site found | Its overall-survival result, expected around 2028, could change the early-treatment debate |
Sources: CTIS CLL18; GCLLSG CLL18 page; CLL18 synopsis; RCC CLL18; NCT06136559; CTIS BELLWAVE-011; NCT07277231; CTIS BGB-11417-304; CTIS PreVent-ACaLL; NCT03868722; NCT04269902.
[I] In short:
- Under watch-and-wait: no interventional trial open to patients at this stage is recruiting in Sweden or nearby Denmark.
- If treatment becomes indicated: CLL18 at Lund is the only nearby first-line trial that needs no travel to Stockholm or Denmark.
- Unverified: whether Danish sites accept Swedish residents, and how insurance and follow-up would work across the border.
- Supportive care: no CLL supportive-care or vaccine trial is recruiting in Sweden.
17.2 Registry discrepancies to be aware of¶
| Trial | Discrepancy |
|---|---|
| CLL18/MOIRAI | Absent from ClinicalTrials.gov; recruiting at Lund according to CTIS and RCC (resolved in favour of CTIS and RCC) |
| PreVent-ACaLL | "Recruiting" on ClinicalTrials.gov (last updated December 2023); recruitment ended according to CTIS and RCC |
| IbruOnOff | "Recruiting" on ClinicalTrials.gov (last updated February 2021), with a Lund site listed as "not yet recruiting"; the trial ended in April 2026 according to CTIS |
| CaDAnCe-101 | Recruiting according to ClinicalTrials.gov and CTIS; "avslutad" (ended) according to RCC |
| HOVON 180 | ClinicalTrials.gov lists Örebro and Rigshospitalet; in CTIS only the Netherlands is authorised |
| AETHER | Aalborg is "withdrawn" on ClinicalTrials.gov but still listed in CTIS |
17.3 Awareness list: relapse and Richter trials (not relevant at diagnosis)¶
Relapsed CLL:
- CELESTIAL-RRCLL (sonrotoclax + anti-CD20 vs venetoclax-rituximab): Lund, Gothenburg, Stockholm, Uppsala; Rigshospitalet, Roskilde (NCT06943872).
- CaDAnCe-304 (the BTK degrader tacabrutideg vs pirtobrutinib, after a covalent BTKi): Gothenburg, Stockholm (NCT06973187).
- CaDAnCe-101 (phase 1/2 degrader trial, including Richter): Gothenburg and Stockholm (ClinicalTrials.gov and CTIS); Uppsala is listed only in CTIS (NCT05006716; CTIS).
- HOVON 180/ODYSSEUS (pirtobrutinib + epcoritamab): Örebro and Rigshospitalet planned; not yet recruiting (NCT07860775).
- AETHER/HOVON 165 (venetoclax + epcoritamab): Rigshospitalet, Odense (NCT05791409).
Richter transformation:
- CLL-RT1 (zanubrutinib + tislelizumab ± sonrotoclax): Rigshospitalet (NCT04271956).
- CLLRT2 (pirtobrutinib + epcoritamab vs R-(mini)-CHOP, untreated Richter): authorised in Denmark, not yet recruiting (CTIS).
Phase 1 trials in Copenhagen: SOUNDTRACK-E (NCT06564038), TITANium (NCT06542250), JNJ-95804306 (NCT07572006) and IM-1021 (NCT06823167).