NCT06368167Not yet recruitingPhase 2
A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase II, Single-arm, Open-label, Multicenter Study on the Efficacy of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
Source: ClinicalTrials.gov · Last updated 16 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 11 Apr 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Follicular lymphoma
- NCT number
- NCT06368167
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 105
- From 1 Apr 2024 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have been treated with a compound of the same machanism;
- Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation or CAR-T therapy within 90 days;
- Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug
- Have other malignancies within 5 years prior to screening Pregnant or lactating women
Other illness
- Known active infection
- History of clinically severe cardiovascular diseases
- The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption.
Lab values
- Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination
Other
- Accompanied by central nervous system infiltration;
- The subject is taking a known medium or strong CYP inducer.
Who the study is looking for
- Males or females aged ≥18 years
- Histologically confirmed follicular lymphoma
- Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2
- Life expectancy ≥ 12 weeks
- Treated with CD20 antibody, refractory to or relapse from prior anti-cancer therapies
- Have measurable lesions
- The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.