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

NCT ID: NCT05552937

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2027-04-30

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

Conditions

DLBCL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tafasitamab and Lenalidomide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Afflicated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huili Zhou

Role: CONTACT

Yixuelunli123@163.com

86 571-87236685

Facility Contacts

Jie Jin

Role: primary

jiej0503@163.com

0571-87236114

Other Identifiers

ICP-CL-00901

Identifier Type: -

Identifier Source: org_study_id