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Clinical Trials List

Protocol NumberINCMOR 0208-301

NCT Number(ClinicalTrials.gov Identfier)NCT04680052

Active

2021-04-01 - 2029-09-01

Phase III

Recruiting9

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

Trial Applicant

Syneos Health
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Yao-Chung Liu 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宇欽無

Tri-Service General Hospital

Co-Principal Investigator

吳宜穎無
戴明燊無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 余垣斌 Division of Hematology & Oncology

Far Eastern Memorial Hospital

Co-Principal Investigator

謝佩穎無
林世強無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 譚傳德無

Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

邱倫瑋無
鄭小湘無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 田豐銘 Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王銘崇無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇裕傑 Division of Hematology & Oncology

E-DA Hospital

Co-Principal Investigator

楊文祺 Division of Hematology & Oncology
Sheng-Fung Lin 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Su-Peng Yeh 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Tsai-Yun Chen

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Follicular Lymphoma

Objectives

The primary objective of this trial was to compare the efficacy of tafasitamab and lenalidomide plus rituximab compared to placebo and lenalidomide plus rituximab in R/R FL participants based on progression-free survival (PFS).

Test Drug

懸液用粉劑

Active Ingredient

Tafasitamab

Dosage Form

141

Dosage

MG

Endpoints

PFS was assessed by the trial administrator (INV) in the FL population using the Lugano 2014 criteria (Cheson et al 2014). PFS was defined as the time from randomization until the first recorded disease exacerbation or death from any cause (whichever occurs first).

Inclution Criteria

Inclusion Criteria:

Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
Willingness to avoid pregnancy or fathering children
In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
Documented relapsed, refractory, or PD after treatment with systemic therapy
ECOG performance status of 0 to 2

Exclusion Criteria

Exclusion Criteria:

Women who are pregnant or breastfeeding.
Any histology other than FL and MZL or clinical evidence of transformed lymphoma
Prior non-hematologic malignancy
Congestive heart failure
HCV positivity, chronic HBV infection or history of HIV infection
Active systemic infection
CNS lymphoma involvement
Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
Prior use of lenalidomide in combination with rituximab

The Estimated Number of Participants

Taiwan

15 participants
Global

618 participants