Mitoxantrone Hydrochloride Liposome Combined With Rituximab and Lenalidomide (M+R2) in Patients With Relapsed and Refractory Diffuse Large B-Cell Lymphoma

NCT05575973 | Unknown Phase 2

• 1 other identifier: CSPC-DED-DLBCL-K03
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with rituximab and lenalidomide in the treatment of relapsed and refractory diffuse large B-cell lymphoma (DLBCL).

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To investigate the preliminary antitumor efficacy

  through study completion, an average of 2 year

Secondary Outcomes (5)

• Progression free survival (PFS)

  through study completion, an average of 2 year

• Duration of relief (DOR)

  through study completion, an average of 2 year

• Disease Control Rate (DCR)

  through study completion, an average of 2 year

• Best of response (BOR)

  6-8 weeks

• Safety endpoint: The incidence and severity of AE and SAE Safety endpoint: The incidence and severity of AE and SAE Safety endpoint:The incidence and severity of AE and SAE

  through study completion, an average of 2 year

Other Outcomes (2)

• Efficacy assessed by IgNGS

  through study completion, an average of 2 year

• Other metrics that researchers are interested

  through study completion, an average of 2 year

Study Arms (1)

mitoxantrone hydrochloride liposome

EXPERIMENTAL

Patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL) will receive sequentially mitoxantrone hydrochloride liposome in combination with rituximab and lenalidomide for up to 6 cycles (28 days per cycle).

Drug: Mitoxantrone Hydrochloride Liposome; Drug: Rituximab; Drug: Lenalidomide

Interventions

Mitoxantrone Hydrochloride Liposome DRUG

Drug: Mitoxantrone hydrochloride liposome (20 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.

mitoxantrone hydrochloride liposome

Rituximab DRUG

Drug: Rituximab (375 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.

mitoxantrone hydrochloride liposome

Lenalidomide DRUG

Drug: Lenalidomide (25 mg) will be taken orally from day 1 to day 8 of each 28-day cycle.

mitoxantrone hydrochloride liposome

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects fully understand and voluntarily participate in this study and sign the informed consent form (ICF);
• years old;
• Expected survival ≥ 3 months;
• Subjects with histologically confirmed diagnosis of relapsed and refractory diffuse large B-cell lymphoma who have received at least 4 cycles of first-line chemotherapy including rituximab and anthracyclines; Relapsed lymphoma is defined as the lymphoma that relapse after obtaining complete response (CR) after initial chemotherapy; Refractory lymphoma subjects meet one of the following conditions: 1) The tumor shrinks \<50% or disease progression after 4 cycles of standard chemotherapy,; 2) CR after standard chemotherapy, but relapse within half a year; 3) 2 or more relapses after CR; 4) relapse after hematopoietic stem cell transplantation;
• Subjects who are not eligible for transplantation or do not plan to undergo transplantation at the beginning of the study;
• ECOG Performance Status: 0-2;
• Subjects must have at least one evaluable or measurable lesion per lugano2014 criteria: for lymph node lesions, the length should be \> 1.5cm; For non-lymph node lesions, the length should be \> 1.0cm;
• Bone marrow function: Absolute neutrophil count ≥1.5×109/L, Platelet count ≥75×109/L, Hemoglobin ≥ 80g/L (Absolute neutrophil can be relaxed to ≥ 1.0×109/L, Platelet count can be relaxed to ≥50×109/L, Hemoglobin can be relaxed to ≥75 g/L in subjects with poor bone-marrow reserve);
• Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN (≤ 3×ULN for subjects with liver metastases).

You may not qualify if:

• \. The subject had previously received any of the following anti-tumor treatments:
• Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;
• Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin);
• Subjects who received anti-tumor treatment (including chemotherapy, targeted therapy, glucocorticoid, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received trial drugs within 4 weeks or 5 T1/2s before the first administration of the study drugs;
• Subjects who received lenalidomide.
• Subjects with refractory lymphoma meet one of the following criteria: 1) Tumors assessed as SD/PD after ≥2 lines of chemotherapy; 2) Subjects relapse within 6 months after transplantation.
• Hypersensitivity to any study drug or its components;
• Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)
• Heart function and disease meet one of the following conditions:
• Long QTc syndrome or QTc interval \> 480 ms;
• Complete left bundle branch block, grade II or III atrioventricular block;
• Serious and uncontrolled arrhythmias requiring drug treatment;
• New York Heart Association grade ≥ III;
• Cardiac ejection fraction (LVEF)\< 50%;
• A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.

Sponsors & Collaborators

• Jianfeng Zhou: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Department of Hematology Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Lenalidomide

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

liang Huang

CONTACT

027-83665555; lhuang@tjh.tjmu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 12, 2022
• Study Start: October 10, 2022
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

CN (1)