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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orelabrutinib Tafasitamab Lenalidomide | Experimental | Orelabrutinib tafasitamab Lenalidomide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orelabrutinib | Drug | Orelabrutinib 150 mg orally once daily on Days 1-28 of each 28-day cycle during induction therapy and maintenance therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks) |
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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:
7. Ability to provide written informed consent.
Exclusion Criteria:
9. Patients deemed ineligible by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuhua Yi, Dr | Contact | +86-022-23909106 | yishuhua@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | China |
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| 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. |
|
| 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. |
|
| Progression-Free Survival (PFS) |
The time from the start of treatment to disease progression or death from any cause. |
| 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 | 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. | Up to approximately 3 years |
| Overall Survival (OS) | The time from the start of treatment to death from any cause. | Up to approximately 3 years |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| Qilu Hospital of Shandong Province | Jinan | Shandong | China |
|
| Institute of Hematology & Blood Diseases Hospital, China | Tianjin | Tianjin Municipality | 300020 | China |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
| C000613469 | tafasitamab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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