Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2026-04-15
Last updated
2026-05-14
Condition(s) studied
Follicular Lymphoma
Investigational drug(s) / intervention(s)
OrelabrutinibTafasitamabLenalidomide
Orelabrutinib: Orelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy.
Tafasitamab: Tafasitamab 12 mg/kg administered by intravenous infusion on Days 1, 4, 8, 15, and 22 in Cycle 1; on Days 1, 8, 15, and 22 in Cycles 2-3; and on Days 1 and 15 from Cycle 4 onward during induction therapy.
Lenalidomide: Lenalidomide 20 mg orally once daily on Days 1-21 of each 28-day cycle during induction therapy and 10 mg orally once daily on Days 1-21 of each 28-day cycle during maintenance therapy.
Study summary
Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age \> 18 years, regardless of gender;
2. Newly diagnosed patients with follicular lymphoma (Grade 1, 2, or 3a) confirmed histologicallyaccording to the World Health Organization (WHO) classification of diseases;
3. Deemed by the investigator to have an indication for treatment and require therapy;
4. ECOG performance status score of 0-2;
5. Laboratory tests meeting the following criteria:
1. 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;
2. Liver function: AST/ALT s 2xULN, TBILI s 2xULN;
3. 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.
Exclusion Criteria:
1. Women with a positive serum pregnancy test or who are breastfeeding;
2. Patients with lymphoma involving the central nervous system (CNS);
3. 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%;
4. Patients with grade \>2 neuropathy;
5. Patients with active hepatitis B (HBV, hepatitis C (HCV, or other acquired/congenitalimmunodeficiency diseases;
6. Patients with severe active infections requiring systemic antibiotic treatment;
7. 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.
Primary outcome measure(s)
Objective Response Rate (ORR) — At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks) Percentage of participants achieving a Complete Response (CR) or Partial Response (PR) at the end of cycle 12, assessed according to the Lugano 2014 classification
Trial sites (5)
Facility
City
Region
Status
Shenzhen Second People's Hospital
Shenzhen
Guangdong
Henan Cancer Hospital
Zhengzhou
Henan
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Qilu Hospital of Shandong Province
Jinan
Shandong
Institute of Hematology & Blood Diseases Hospital, China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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