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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)]

Secondary outcome measures (5)

• Complete Response (CR) Rate [Time frame: At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)]
• Progression-Free Survival (PFS) [Time frame: Up to approximately 3 years]
• Rate of Progression of Disease within 24 Months (POD24) [Time frame: 24 months]
• Incidence and Severity of Adverse Events (AEs) [Time frame: Up to approximately 3 years]
• Overall Survival (OS) [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;

9\. Patients deemed ineligible by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 5 centers

• Shenzhen Second People's Hospital — Shenzhen
• Henan Cancer Hospital — Zhengzhou
• The First Affiliated Hospital of Nanchang University — Nanchang
• Qilu Hospital of Shandong Province — Jinan
• Institute of Hematology & Blood Diseases Hospital, China — Tianjin

Identifiers

NCT: NCT07585747 · IIT2026026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗