A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Beijing InnoCare Pharma Tech Co., Ltd.1 site in 1 country50 target enrollmentSeptember 6, 2021

ConditionsDLBCL

InterventionsTafasitamab and Lenalidomide

DrugsTafasitamab and Lenalidomide

Overview

Phase: Phase 2
Intervention: Tafasitamab and Lenalidomide
Conditions: DLBCL
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 50
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Registry

clinicaltrials.gov

Start Date

September 6, 2021

End Date

April 2027

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age \>18 years.
•Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); T cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma, Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
•Patients received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy.
•Patients must meet the following laboratory criteria at screening.
•Patients must use an effective barrier method of contraception.
•In the opinion of the investigator the patients must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events; be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.

Exclusion Criteria

•Patients who have other histological type of lymphoma，primary refractory DLBCL，a history of "double/triple hit" genetics.
•Patients who have, within 14 days prior to Day 1 dosing:
•not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.
•undergone major surgery or suffered from significant traumatic injury.
•received live vaccines.
•required parenteral antimicrobial therapy for active, intercurrent infections.
•Patients who:
•were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).
•have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
•have undergone previous allogenic stem cell transplantation.

Arms & Interventions

Tafasitamab and Lenalidomide

Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.

Intervention: Tafasitamab and Lenalidomide

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 1-3 years approximately

Evaluation by the Independent Review Committee (IRC).

Secondary Outcomes

Time to maximum serum concentration (tmax)(2 years)
Objective Response Rate (ORR)(1-3 years approximately)
Duration of Response (DOR)(1-3 years approximately)
Progression Free Survial (PFS)(1-3 years approximately)
Disease Control Rate (DCR)(1-3 years approximately)
Potential immunogenicity of Tafasitamab.(2 years)
Maximum serum concentration (Cmax)(2 years)
Overall Survival (OS)(1-3 years approximately)
Safety of Lenalidomide combined with Tafasitamab according to the frequency and severity of adverse events (AEs).(2 years)
Apparent trough serum concentration before dosing (Cpd)(2 years)
Time to progression (TTP)(1-3 years approximately)
Time to response (TTR)(1-3 years approximately)
Area under the serum concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t)(2 years)