Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory DLBCL

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

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

Study Overview

• Status: Recruiting
• Conditions: DLBCL
• Intervention / Treatment: Drug: Tafasitamab and Lenalidomide

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Huili Zhou; Phone Number: 86 571-87236685; Email: Yixuelunli123@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Afflicated Hospital, College of Medicine, Zhejiang University
      • Contact: Jie Jin; Phone Number: 0571-87236114; Email: JIEJ0503@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >18 years.
2. 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.
3. 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.
4. Patients must meet the following laboratory criteria at screening.
5. Patients must use an effective barrier method of contraception.
6. 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:

1. Patients who have other histological type of lymphoma，primary refractory DLBCL，a history of "double/triple hit" genetics.

2. Patients who have, within 14 days prior to Day 1 dosing:

   1. not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.
   2. undergone major surgery or suffered from significant traumatic injury.
   3. received live vaccines.
   4. required parenteral antimicrobial therapy for active, intercurrent infections.

3. Patients who:

   1. were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).
   2. have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
   3. have undergone previous allogenic stem cell transplantation.
   4. have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
   5. concurrently use other anticancer or experimental treatments.
4. Prior history of malignancies other than DLBCL.

5. Patients with:

   1. positive hepatitis B and/or C serology.
   2. known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
   3. CNS lymphoma involvement.
   4. history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.
   5. history or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Tafasitamab and Lenalidomide; Tafasitamab will be administered intravenously in 28-day cycles. During Cycles 1 through 3, tafasitamab will be administered weekly on Days 1, 8, 15, and 22; an additional loading dose will be administered on Cycle 1 Day 4. Starting with Cycle 4, tafasitamab will be administered on Days 1 and 15 of each cycle. Participants will self-administer lenalidomide capsules orally on Days 1-21 of each 28-day cycle, up to 12 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Evaluation by the Independent Review Committee (IRC).	1-3 years approximately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum serum concentration (Cmax)		2 years
Objective Response Rate (ORR)	Evaluated by the IRC according to cheson 2007 and cheson 2014.	1-3 years approximately
Disease Control Rate (DCR)		1-3 years approximately
Duration of Response (DOR)		1-3 years approximately
Progression Free Survial (PFS)		1-3 years approximately
Time to progression (TTP)		1-3 years approximately
Time to response (TTR)		1-3 years approximately
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
Potential immunogenicity of Tafasitamab.		2 years
Time to maximum serum concentration (tmax)		2 years
Apparent trough serum concentration before dosing (Cpd)		2 years
Area under the serum concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t)		2 years

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2027

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: ICP-CL-00901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No