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

NCT07585747 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2026026
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Follicular Lymphoma

Keywords

lenalidomide; tafasitamab; orelabrutinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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

  At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)

Secondary Outcomes (5)

• Complete Response (CR) Rate

  At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)

• Progression-Free Survival (PFS)

  Up to approximately 3 years

• Rate of Progression of Disease within 24 Months (POD24)

  24 months

• Incidence and Severity of Adverse Events (AEs)

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

Study Arms (1)

Orelabrutinib Tafasitamab Lenalidomide

EXPERIMENTAL

Orelabrutinib tafasitamab Lenalidomide

Drug: Orelabrutinib; Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Orelabrutinib DRUG

Orelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy.

Orelabrutinib Tafasitamab Lenalidomide

Tafasitamab DRUG

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.

Orelabrutinib Tafasitamab Lenalidomide

Lenalidomide DRUG

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.

Orelabrutinib Tafasitamab Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \. Ability to provide written informed consent.

You may not qualify if:

• Women with a positive serum pregnancy test or who are breastfeeding;
• Patients with lymphoma involving the central nervous system (CNS);
• 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%;
• Patients with grade \>2 neuropathy;
• 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;
• \. Patients deemed ineligible by the investigator.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (5)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Qilu Hospital of Shandong Province

Jinan, Shandong, China

Location

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

orelabrutinib; tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Shuhua Yi, Dr

CONTACT

+86-022-23909106; yishuhua@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 14, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)