Follicular Lymphoma
Conditions
Keywords
lenalidomide, tafasitamab, orelabrutinib
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.
Interventions
DRUGOrelabrutinib
Orelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy.
DRUGTafasitamab
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.
DRUGLenalidomide
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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response (CR) Rate | At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks) | 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 |
| Progression-Free Survival (PFS) | Up to approximately 3 years | The time from the start of treatment to disease progression or death from any cause. |
| Rate of Progression of Disease within 24 Months (POD24) | 24 months | Percentage of participants experiencing disease progression within 24 months from the initiation of treatment |
| Incidence and Severity of Adverse Events (AEs) | Up to approximately 3 years | Safety evaluated by monitoring the incidence and severity of AEs, graded according to the NCI CTCAE v5.0. |
| Overall Survival (OS) | Up to approximately 3 years | The time from the start of treatment to death from any cause. |
Countries
China
Contacts
CONTACTShuhua Yi, Dr
Outcome results
None listed