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NCT07585747Not yet recruitingPhase 2

A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide

A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
27 (estimated)
First submitted
13 Apr 2026
Start date
15 Apr 2026
Primary completion date
31 Dec 2029
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT07585747

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 27
  • From 15 Apr 2026 to the primary completion date, 31 Dec 2029
  • 5 sites 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.

Other illness

  • Patients with active hepatitis B (HBV, hepatitis C (HCV, or other acquired/congenitalimmunodeficiency diseases;
  • Patients with severe active infections requiring systemic antibiotic treatment;
  • Patients with a history of severe neurological or psychiatric disorders that impair trialparticipation, including dementia, epilepsy, severe depression, and mania;8. Drug abuse, or medical, psychological, or social conditions that may interfere with studyparticipation or result evaluation;
    • 9\. Patients deemed ineligible by the investigator.

Lab values

  • Women with a positive serum pregnancy test or who are breastfeeding;
  • Clinically significant heart disease, including unstable angina, acute myocardial infarction within6 months prior to randomization, congestive heart failure with New York Heart Association(NYHA) functional class IIl or IV, or left ventricular ejection fraction \<50%;

Other

  • Patients with lymphoma involving the central nervous system (CNS);
  • Patients with grade \>2 neuropathy;

Who the study is looking for

  • Age \> 18 years, regardless of gender;
  • Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;
  • Deemed by the investigator to have an indication for treatment and require therapy;
  • ECOG performance status score of 0-2;
  • Laboratory tests meeting the following criteria:
    • Bone marrow hematopoietic function is essentially normal: WBC 3.5x10\^9/L, ANC \> 1.0x10\^9/L, PLT \> 75x10\^9/L, Hb \> 80 g/L;
    • Liver function: AST/ALT s 2xULN, TBILI s 2xULN;
    • Renal function: Creatinine clearance rate \> 50 ml/min;6. Presence of at least one measurable lesion: Lymph node lesion with a long diameter \> 1.5 cm orextranodal lesion with a long diameter \> 1.0 cm as shown by PET/CT, CT, or MRl, or a lesion \> 2cm assessed by clinical examination;
    • 7\. Ability to provide written informed consent.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Qilu Hospital of Shandong Province
Coordinator of this site? Confirm its status
JinanChinaUnknown status
The First Affiliated Hospital of NanChang University
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Shenzhen Second People's Hospital
Coordinator of this site? Confirm its status
ShenzhenChinaUnknown status
Institute of Hematology & Blood Diseases Hospital, China
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.