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Clinical Trials in China / NCT07585747
Starting soon Phase 2

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

NCT07585747 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (5)

FacilityCityRegionStatus
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 Tianjin Tianjin Municipality

On this site

📄 Revlimid (lenalidomide) drug profile →

More Institute of Hematology & Blood Diseases Hospital, China trials in China

Other trials for the same condition

Official registry record

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.

View NCT07585747 on ClinicalTrials.gov ↗ ← All trials in China