Last updated: September 21, 2022
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
N/AClinical Study ID
NCT05552937
ICP-CL-00901
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age >18 years.
- Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); Tcell/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, accordingto the Revised European American Lymphoma/World Health Organization (REAL/WHO)classification. Additionally, patients with the evidence of histologicaltransformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., anindolent pathology such as follicular lymphoma, marginal zone lymphoma, chroniclymphocytic leukaemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
- Patients received at least one, but no more than three previous systemic regimens forthe treatment of DLBCL and one therapy line must have included a CD20-targetedtherapy.
- 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 receiveadequate prophylaxis and/or therapy for thromboembolic events; be able to understandthe reason for complying with the special conditions of the pregnancy prevention riskmanagement plan and give written acknowledgement of this.
Exclusion
Exclusion Criteria:
- Patients who have other histological type of lymphoma,primary refractory DLBCL,ahistory 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 informedconsent form.
- have undergone previous allogenic stem cell transplantation.
- have a history of deep venous thrombosis/embolism and who are not willing/able totake venous thromboembolic event prophylaxis during the entire treatment period.
- concurrently use other anticancer or experimental treatments.
- Prior history of malignancies other than DLBCL.
- Patients with:
- positive hepatitis B and/or C serology.
- known seropositivity for or history of active viral infection with humanimmunodeficiency virus (HIV).
- CNS lymphoma involvement.
- history or evidence of clinically significant cardiovascular, CNS and/or othersystemic disease that would in the investigator's opinion preclude participationin the study or compromise the patient's ability to give informed consent.
- history or evidence of severe hepatic impairment (total serum bilirubin > 3mg/dL).
Study Design
Total Participants: 50
Study Start date:
September 06, 2021
Estimated Completion Date:
April 30, 2027
Connect with a study center
The First Afflicated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting

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