- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05784987
R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
March 23, 2023 updated by: The First Affiliated Hospital with Nanjing Medical University
An Open, Single-arm, Multi-center Clinical Trial of Molecular Subtype-guided R-MINE+X Regimen in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Based on the modified R-MINE of mitoxantrone hydrochloride liposome, the corresponding targeted drug (X) was added according to the genotyping detected by second-generation gene sequencing (NGS) to explore the effectiveness and safety of R-MINE+X in the treatment of recurrent/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Compared with traditional mitoxantrone, mitoxantrone liposomes can significantly prolong the survival time of patients and reduce the cardiotoxicity and non-hematological toxicity of anthracycline drugs.
At present, there are no studies on the efficacy and safety of R-MINE+X regimen based on molecular typing in the treatment of R/R DLBCL.
Therefore, based on NGS, R/R DLBCL was divided into different molecular types (MCD subtype, BN2 subtype, EZB subtype, A53 subtype and other subtype), and on this basis, different molecular types of targeted drugs (X: MCD/BN2 subtype - BTK inhibitor, EZB subtype - Chidamide, A53 subtype - PD-1 monoclonal antibody and other type - lenalidomide) were used to treat R/R DLBCL.
The main purpose was to observe the effectiveness and safety of the program in R/R DLBCL.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jinhua Liang, M.D
- Phone Number: 15952032421
- Email: 1151525490@qq.com
Study Contact Backup
- Name: Wei Xu, PhD& MD
- Phone Number: 862568136034
- Email: xuwei10000@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Join the study voluntarily and sign the informed consent;
- Age ≤ 18 years old ≤75 years old;
- Expected survival time ≥3 months;
- Recurrent or refractory diffuse large B-cell lymphoma confirmed by histopathology;
- Consistent with relapsed or refractory lymphoma: Relapsed lymphoma refers to lymphoma that relapsed after CR obtained from initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following criteria: 1) tumor shrinkage < 50% or progression after 4 courses of chemotherapy prescribed by the standard regimen; 2) CR was achieved by standard chemotherapy, but recurrent within half a year; 3) Relapse for two or more times after CR; 4) Recurrence after hematopoietic stem cell transplantation;
- There must be at least one evaluable or measurable lesion in line with Lugano2014 criteria: lymph node lesion, the length and diameter of detectable lymph node must be greater than 1.5cm; For non-lymph node lesions, the diameter of extrinsic lesions should be > 1.0cm;
- ECOG score 0-2;
- Bone marrow function: neutrophil count ≥1.5×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥80g/L (neutrophil count ≥1.0×10^9/L, platelet count ≥50×10^9/L, hemoglobin ≥75g/L in patients with bone marrow involvement);
- Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal value (≤5 times the upper limit of normal value for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion);
Exclusion Criteria:
The subject's previous history of antitumor therapy meets one of the following conditions:
- Previous recipients of mitoxantrone or mitoxantrone liposomes;
- Prior treatment with doxorubicin or anthracycline with a cumulative dose of doxorubicin > 360 mg/m2 (1 mg of doxorubicin for other anthracyclines);
- Patients who had received autologous hematopoietic stem cell transplantation or had received allogeneic hematopoietic stem cell transplantation within 100 days of the first medication;
- Received anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking anti-tumor active Chinese medicine, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the drug in this study;
- Hypersensitivity to any investigational drug or its components;
- Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
Cardiac function and disease conform to one of the following conditions:
- Long QTc syndrome or QTc interval >480 ms;
- Complete left bundle branch block, complete right bundle branch block with left anterior branch block, second degree type II, or third degree atrioventricular block;
- severe, uncontrolled arrhythmias requiring medical treatment;
- New York College of Cardiology Grade ≥ III;
- A history of acute myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmias or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction abnormalities within the 6 months prior to recruitment.
- Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^3 copies /mL; HCV RNA over 1x10^3 copies /mL);
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- Past or present co-existing malignancies (in addition to non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in the past five years);
- Primary or secondary central nervous system (CNS) lymphoma or history of CNS lymphoma at the time of recruitment;
- There is significant gastrointestinal disease at the time of screening that may affect drug intake, transport or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- Pregnant and lactating women and patients of childbearing age who do not wish to take contraceptive measures;
- Situations in which other researchers have determined that participation in this study is not appropriate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: R-MINE+X
R-MINE: Rituximab, Isophosphamide, Mitoxantrone hydrochloride liposome, Etoposide X: Orelabrutinib, Chidamide, Penpulimab, Lenalidomide |
375 mg/m2, d0, Cycle 1~4
20 mg/m2, d1, Cycle 1~4
1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1~4
65 mg/m2, d1-3, Cycle 1~4
MCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2~4
EZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2~4
TP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2~4
Other-X: Lenalidomide: 25mg/d, d1-10, Cycle 2~4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate(ORR)
Time Frame: up to 4 cycles of chemotherapy(each cycle is 21 days)
|
Objective response rate (ORR) after 4 cycles of R-MINE+X chemotherapy
|
up to 4 cycles of chemotherapy(each cycle is 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free-Survival rate
Time Frame: 1 year
|
from date of inclusion to date of progression, relapse, or death from any cause
|
1 year
|
Overall survival rate
Time Frame: 1 year
|
from the date of inclusion to date of death, irrespective of cause
|
1 year
|
Adverse events (AE)
Time Frame: From the first day of medication to 28 days after the last dose
|
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard
|
From the first day of medication to 28 days after the last dose
|
Complete remission rate(CRR)
Time Frame: up to 4 cycles of chemotherapy(each cycle is 21 days)
|
Complete remission rate(CRR) after 4 cycles of R-MINE+X chemotherapy
|
up to 4 cycles of chemotherapy(each cycle is 21 days)
|
Duration of remission(DOR)
Time Frame: up to 4 cycles of chemotherapy(each cycle is 21 days)
|
Time from reaching CR or PR for the first time to disease progression
|
up to 4 cycles of chemotherapy(each cycle is 21 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 15, 2023
Primary Completion (Anticipated)
January 1, 2024
Study Completion (Anticipated)
January 1, 2025
Study Registration Dates
First Submitted
March 2, 2023
First Submitted That Met QC Criteria
March 23, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Etoposide
- Lenalidomide
- Ifosfamide
- Isophosphamide mustard
- Rituximab
- Mitoxantrone
Other Study ID Numbers
- CSPC-DED-DLBCL-K09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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