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ClinicalTrials.gov ID

NCT07585747

Lead Sponsor

Institute of Hematology & Blood Diseases Hospital, ChinaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

27Estimated

Last Update Posted

May 14, 2026Actual

Start Date

Apr 15, 2026Estimated

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2030Estimated

Official Title

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

Brief Summary

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

Detailed Description

Follicular lymphoma (FL) is the most common indolent non-Hodgkin's lymphoma (NHL), accounting for 35% of NHL cases . The median age at diagnosis is 65 years , and most patients are diagnosed at an advanced stage. Although FL is still considered incurable, the clinical prognosis for most patients remains favorable.Currently, there is some data available for BTKi and tafasitamab in relapsed/refractory follicular lymphoma, and further exploration of relevant data in the first-line setting is needed. This combination therapy may provide new options for patients with follicular lymphoma.

• Follicular Lymphoma

• Orelabrutinib
• Tafasitamab
• Lenalidomide

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Institute of Hematology & Blood Diseases Hospital, ChinaOTHER

18560086995