Zanubrutinib+Lenalidomide+R-ICE in Relapsed/Refractory DLBCL

NCT06033820 | Recruiting Phase 2

• 1 other identifier: IIT-2022-0229
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single center, single arm, open label study of zanubrutinib, lenalidomide in combination with Rituximab-ICE for treatment of relapsed/refractory diffuse large B-cell lymphoma.

Conditions

Diffuse Large B-cell Lymphoma Recurrent; Diffuse Large B Cell Lymphoma Refractory

Keywords

diffuse large B-cell lymphoma; Zanubrutinib; Lenalidomide; Salvage therapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To evaluate the efficacy in terms of objective response rate including CR and PR rate after three cycles of ZR2-ICE

  9 weeks

Secondary Outcomes (5)

• Complete remission rate (CR)

  9 weeks

• DOR

  Up to 2 years

• Progression-free survival

  Up to 2 years

• Overall survival

  Up to 2 years

• Safety Management Study

  Up to 100 days

Study Arms (1)

ZR2-ICE Group

EXPERIMENTAL

All patients will receive 3 cycles of ZR2-ICE immunochemotherapy every three weeks.

Drug: ZR2-ICE

Interventions

ZR2-ICE DRUG

* Drug: zanubrutinib Oral Capsule * Drug: lenalidomide Oral Capsule * Drug: R-ICE chemotherapy

ZR2-ICE Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age between 18 years and 75 years 2. Histologically confirmed diagnosis of DLBCL, CD20 positive 3. Patients received at least one systemic regimens for the treatment of DLBCL, and one therapy line must have included a CD20-targeted therapy.
• \. Relapsed or refractory disease 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Measurable disease on cross section imaging by PET and/or CT that is at least 1.5 cm in the longest diameter and measurable in two perpendicular dimensions as defined by IWG criteria.
• \. Patients must meet the following laboratory criteria at screening, including:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L or ≥0.75 x 109/L if bone marrow involvement
• Platelets ≥90 x 109/L or ≥50 x 109/L if bone marrow involvement
• Hemoglobin ≥75 g/dL or ≥50 g/dL if bone marrow involvement
• Total bilirubin ≤2.5 x upper limit of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of hepatic involvement.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤3 x (ULN) or \< 5 x ULN if hepatic involvement.
• Creatinine Clearance Rate ≥60 mL/min.
• INR ≤1.5 x ULN and aPTT ≤1.5 x ULN 8. Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[β-hCG\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study. Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. For females, these restrictions apply for 3 month after the last dose of study drug.
• \. Male subject agrees to use an acceptable method for contraception for the duration of the study. Men must agree to not donate sperm during and after the study. For males, these restrictions apply for 3 months after the last dose of study drug.
• \. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study. Must be able to adhere to study visit schedules and other protocol requirements.

You may not qualify if:

• \. Patients who have a history of "double/triple hit" genetics. 2. 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. 3. Patients who have use investigational agents within the period ≤ 3 months prior to Day 1 dosing.
• \. Patients who have,
• Adverse events (AEs) due to previous anti-tumor therapy have not recovered
• Known allergy or sensitivity to any drug contained in the regimen
• have undergone ASCT within the period ≤3 months prior to signing the informed consent form.
• have undergone previous allogenic stem cell transplantation.
• 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.
• concurrently use other anticancer or experimental treatments. 5. Coexistent second malignancy or history of prior malignancy within previous 5 years.
• \. Patients who have,
• Known history of active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
• Known history of human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hong-Hui Huang, Professor

CONTACT

00862168383144; huanghonghui@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: October 12, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)