Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

NCT05875428 | Unknown Phase 2

• 1 other identifier: HE071-033
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, single-arm, phase 2 study of mitoxantrone hydrochloride liposome injection in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• ORR assessed by the IRC

  ORR (objective response rate) assessed by the Independent Review Committee (IRC)

  Throughout the study period, up to approximately 2 years

Secondary Outcomes (7)

• ORR assessed by investigators

  Throughout the study period, up to approximately 2 years

• DCR

  Throughout the study period, up to approximately 2 years

• DOR

  Throughout the study period, up to approximately 2 years

• PFS

  Throughout the study period, up to approximately 2 years

• OS

  Throughout the study period, up to approximately 2 years

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

The eligible patients will receive mitoxantrone hydrochloride liposome injection (20 mg/m\^2) once every 4 weeks for a maximum of 8 cycles.

Drug: Mitoxantrone Hydrochloride Liposome Injection

Interventions

Mitoxantrone Hydrochloride Liposome Injection DRUG

Be given intravenously at 20 mg/m\^2 on days 1 of each treatment cycle.

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

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

You may qualify if:

• Able to understand and comply with the study, and voluntarily sign informed consent.
• Age ≥ 18 years old.
• Previously treated, pathologically confirmed primary DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
• Patients are not suitable for high-dose chemotherapy combined with autologous stem cell transplantation as rescue therapy.
• Relapsed or refractory disease after at least (≥) 2 lines of systemic therapy (including at least a regimen of anti-CD20 immunotherapy combined with cytotoxic drugs was included), there is no suitable and conventional therapy.
• Patients have at least one measurable lesion in accordance with the Lugano evaluation criteria (version 2014):(if the only measurable lesion has received radiotherapy in the past, there must be evidence of radiological progression after radiotherapy).
• Confirmation of no objective response from the most recent therapy (at least 2 cycles of administration, and efficacy assessed as stable disease or progressive disease) or disease progression after therapy.
• Patients must agree to provide the most recent tumor tissue section or have a biopsy of tumor tissue.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Estimated life expectancy ≥ 3 months.
• Patients should meet the following requirements and have not received infusion of cell growth factor, blood transfusion, or blood product within 14 days of the hematology test:
• Absolute value of neutrophils ≥ 1.5 × 10\^9/L; Hemoglobin≥80g/L; Platelet ≥ 75 × 10\^9/L;
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST and ALT ≤ 5 × ULN for patients with liver metastasis. Total bilirubin ≤1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome).
• Creatinine clearance ≥ 50 mL/min or serum creatinine ≤ 1.5 × ULN。
• Coagulation function: prothrombin time or activated partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5.

You may not qualify if:

• Primary central nervous system lymphoma, unclassified B-cell lymphoma between DLBCL and classical Hodgkin's lymphoma, primary effusion lymphoma, plasmablastic lymphoma or DLBCL transformed from previously diagnosed non-indolent lymphoma.
• Patients with active central nervous system and meninx involvement.
• Previously treated with mitoxantrone or mitoxantrone liposome.
• Previously treated with adriamycin or other anthracyclines, with the total cumulative dose (doxorubicin equivalent) \> 400 mg/m\^2.
• Previously treated with chimeric antigen receptor T-cell.
• History of autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 6 months prior to screening.
• Patients With interstitial lung disease that requires treatment.
• History of other malignant tumor within 5 years, except for DLBCL in this trial or resected locally cancer that has been cured (e.g.basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
• Participating in any other intervention clinical trials within 4 weeks prior to the first dose except for participation in an observational (non-interventional) clinical study or the follow-up phase of an interventional study.
• Any steroid hormone treatment within 4 weeks prior to the first dose, chemotherapy and targeted therapy within 28 days, radiotherapy within 14 days, antibody therapy within 28 days, Chinese herbal treatment within 14 days.
• Adverse events from the previous treatment have not resolved to ≤ Grade 1 (except for alopecia, hyperpigmentation).
• HIV infection, active hepatitis B (positive for HBsAg, or positive for HBcAb with positive for HBV-DNA PCR), active hepatitis C(positive for anti-HCV with positive for HCV-RNA PCR), or active syphilis infection; for patients with HBV infection, consider enrolment if the disease is under control.
• Patients with active pulmonary tuberculosis.
• Any active infections requiring systemic or venous anti-infective treatment.
• Patients with major surgery within 4 weeks prior to the first dose, and not recovered from any previous creative operation.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, 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

Clinical Trials Information Group officer

CONTACT

+86-0311-69085587; ctr-contact@cspc.cn

Study Design

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

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: July 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: September 30, 2025
• Last Updated: February 8, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)