Clinical trial · Interventional
A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
A Multicenter Exploratory Clinical Study on the Treatment of Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide
NCT07585747CI-TRIAL-00111631CUREMZL002not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the efficacy and safety of orelabrutinib, tafasitamab, and lenalidomide in the first-line treatment of patients with follicular lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Orelabrutinib | Drug | — | UNRESOLVED |
| Tafasitamab | Drug | Tafasitamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabrutinib Tafasitamab Lenalidomide
- description
- Orelabrutinib tafasitamab Lenalidomide
- interventionNames
- Drug: Orelabrutinib
- Drug: Tafasitamab
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- At the end of cycle 12 (each cycle is 28 days; up to approximately 48 weeks)
- description
- 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 outcomes (5)
- measure
- Complete Response (CR) Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.