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

Phase 2Not Yet RecruitingNCT07585747

Institute of Hematology & Blood Diseases Hospital, China27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Follicular Lymphoma

Interventions

OrelabrutinibDRUG

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

TafasitamabDRUG

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.

LenalidomideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Qilu Hospital of Shandong Province

Jinan, Shandong, China

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Complete Response (CR) Rate

The complete response (CR) rate is defined as the percentage of participants who achieve a complete response at the end of cycle 12 , as assessed by the investigator according to the Lugano 2014 classification criteria

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

Progression-Free Survival (PFS)

The time from the start of treatment to disease progression or death from any cause.

Time frame: Up to approximately 3 years

Rate of Progression of Disease within 24 Months (POD24)

Percentage of participants experiencing disease progression within 24 months from the initiation of treatment

Time frame: 24 months

Incidence and Severity of Adverse Events (AEs)

Safety evaluated by monitoring the incidence and severity of AEs, graded according to the NCI CTCAE v5.0.

Time frame: Up to approximately 3 years

Overall Survival (OS)

The time from the start of treatment to death from any cause.

Time frame: Up to approximately 3 years

Central Contacts

Shuhua Yi, Dr

CONTACT

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

Data from ClinicalTrials.gov

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