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NCT06554561
A Study of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma
Phase 1, PHASE2 trial testing Pomalidomide in PCNSL in 43 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 31 August 2024 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- Pomalidomide — full drug profile →
- Rituximab — full drug profile →
- Methotrexate — full drug profile →
Conditions studied
- PCNSL — all drugs for PCNSL →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
Adults 18 to 75, any sex, with PCNSL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, multicenter, single-arm, open Phase Ib/II clinical study to explore the safety and efficacy of pomadomide in combination with rituximab and methotrexate (RPM) in newly diagnosed primary central nervous system lymphoma (PCNSL) subjects. The Phase I study is a dose escalation study, in which rituximab and methotrexate are fixed doses, and pomadomide is set into 3 dose groups: 3mg/d, 4mg/d and 5mg/d. In strict accordance with the "3+3" dose escalation principle, 3-6 subjects are to be recruited in each dose group, and each subject is to be observed for 1 cycle after treatment to determine MTD. Phase II study: RP2D is planned to be determined based on the Phase Ib study, with an additional 25 active participants enrolled to further evaluate efficacy and safety. Subjects with initial treatment of PCNSL who met the inclusion/exclusion criteria were screened, and after signing the informed consent letter, they received 4 courses of PRM regimen. The patients achieving CR or PR were consolidated by autologous transplantation consolidation regimen or the original regimen for 2 courses, and then were given pomadomide maintenance therapy for 12 cycles. Follow-ups should be taken up to the first 3 years.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06554561
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other recruiting trials for PCNSL
Currently open trials in the same condition.
- NCT07350850 — A Multicenter Two-Cohort Study of Methotrexate, Rituximab, Sintilimab and Pirtobrutinib for Treatment-Naive PCNSL vs. Re · Phase 2 · recruiting
- NCT05782374 — Real World Data on Ibrutinib Use in PCNSL Rel/Ref · active not recruiting
Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
- NCT07445152 — Research on Construction and Verification of Multimodal Medical Imaging Large Model · not yet recruiting
- NCT06775665 — A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population · not yet recruiting
- NCT07533422 — Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing · NA · not yet recruiting
- NCT07487285 — A Non-inferiority Study of Laser Combined With Ultrasonic Debridement Therapy (LCUDT) Versus Manual Combined With Ultras · NA · not yet recruiting
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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 NCT06554561 (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 Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 15 August 2024
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