Trial Title:
R-CMOP in Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma
NCT ID:
NCT06594640
Condition:
Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Prednisolone
Cyclophosphamide
Rituximab
Mitoxantrone
Vincristine
Conditions: Keywords:
Mitoxantrone hydrochloride liposome injection
Diffuse Large B-cell Lymphoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mitoxantrone Hydrochloride Liposome
Description:
assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2
Arm group label:
R-CMOP
Intervention type:
Drug
Intervention name:
Rituximab (R)
Description:
375mg/m2, D2
Arm group label:
R-CMOP
Intervention type:
Drug
Intervention name:
Cyclophosphamide (CTX)
Description:
750mg/m2, D2
Arm group label:
R-CMOP
Intervention type:
Drug
Intervention name:
Vincristin
Description:
1.2mg/m2, maximum 2mg， D2
Arm group label:
R-CMOP
Intervention type:
Drug
Intervention name:
Prednisolone
Description:
60mg/m2, D2-6
Arm group label:
R-CMOP
Summary:
This is a prospective clinical study to evaluate the safety and efficacy of R-CMOP in
patients with newly diagnosed diffuse large B-cell lymphoma
Detailed description:
This is an open, multicenter, prospective phase I/II clinical study to evaluate the
safety and efficacy of mitoxantrone hydrochloride liposome injection in combination with
cyclophosphamide, vincristine, prednisone, and rituximab (R-CMOP) in patients with newly
diagnosed diffuse large B-cell lymphoma. The study is divided into two parts. The first
part uses a 3+3 dose-escalation design, in which mitoxantrone hydrochloride liposome
injection in the R-CMOP regimen will be administered at three different doses: 16 mg/m²,
18 mg/m², and 20 mg/m², to determine the recommended Phase 2 dose (RP2D). The second part
follows a single-arm design to evaluate the efficacy and safety of the R-CMOP regimen,
with mitoxantrone hydrochloride liposome injection administered at the RP2D. Each cycle
consists of 21 days. A maximum of 6 cycles of therapy are planned.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;
3. Patients must have been untreated, including chemotherapy, targeted therapy,
immunotherapy, radiotherapy;
4. There must be at least one measurable lesion per the Lugano2014 criteria；
5. For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose
(18FDG) PET-CT positive；
6. Ann Arbor stages II-IV；
7. ECOG score 0~2；
8. Expected survival time ≥3 months;
9. a.)Patients should meet the following requirements and must not have received
treatment with cell growth factors or blood products within 14 days prior to the
hematology test: Absolute value of neutrophils ≥ 1.5 × 10^9/L; Platelet ≥ 75 ×
10^9/L; Hemoglobin≥80g/L. For patients with bone marrow involvement of lymphoma, the
requirements are adjusted as follows: Absolute neutrophil count (ANC) ≥ 1.0 ×
10^9/L; Platelet count ≥ 50 × 10^9/L; Hemoglobin level ≥ 75 g/L.
b.)Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST
and ALT ≤ 5 × ULN for patients with liver involvement. Total bilirubin ≤1.5 × ULN (≤
3 × ULN for patients with Gilbert syndrome); c.)Creatinine clearance ≥ 50 mL/min or
serum creatinine ≤ 2× ULN; d.)Coagulation function: prothrombin time or activated
partial thromboplastin time≤ 1.5 × ULN, and international normalized ratio ≤ 1.5;
10. Female patients of childbearing age must have a negative pregnancy test at the time
of enrollment within one week. And patients must agree to use an effective method of
contraception from the study initiation until at least 12 months after the last
treatment;
11. Able to understand and comply with the study, and voluntarily sign informed consent;
-
Exclusion Criteria:
1. Primary central nervous system DLBCL, Primary testicular large B-cell lymphoma,
Primary mediastinal (thymic) large B-cell lymphoma, Lymphomatoid granulomatosis,
ALK-positive large B-cell lymphoma, Plasmablastic lymphoma, HHV8-positive DLBCL,
Primary effusion lymphoma, Intravascular large B-cell lymphoma, B-cell lymphoma
unclassifiable between DLBCL and classical Hodgkin lymphoma, T-cell/histiocyte-rich
large B-cell lymphoma, and High-grade B-cell lymphoma；
2. transformed indolent lymphoma ;
3. Patients with active central nervous system involvement;
4. History of hematopoietic stem cell transplantation;
5. Have received prior anti-lymphoma treatment, excluding short-term or low-dose
corticosteroids.;
6. Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines
within 14 days prior to the first dose;
7. History of allergy and contraindications to the same class and excipients of the
experimental drug;
8. 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;
9. Active bacterial or viral infections requiring systemic or intravenous drug
treatment.
10. History of immunodeficiency, including anti-HIV positive;
11. Active hepatitis B and C infection (defined as hepatitis B virus surface antigen
positive and hepatitis B virus DNA higher than the Upper limit of normal(ULN);
Hepatitis C virus antibody positive and hepatitis C virus RNA higher than the Upper
limit of normal);
12. syphilis infection;
13. Individuals with an underlying medical condition, alcohol or drug abuse or
dependence that impedes study drug administration or interferes with interpretation
of study drug toxicity and AE, or results in inadequate or reduced adherence to the
study;
14. Patients with interstitial lung disease that requires treatment; 15: A history of
severe cardiovascular disease, including but not limited to:
1. Severe cardiac rhythm or conduction abnormalities, such as ventricular
arrhythmias requiring clinical intervention, or second to third-degree
atrioventricular (AV) block;
2. A mean QTcF interval longer than 450 ms, based on three 12-lead ECGs taken at
rest;
3. Acute coronary syndrome, congestive heart failure, stroke, or any other Grade 3
or higher cardiovascular event occurring within 6 months prior to the first
dose of therapy;
4. NYHA functional class ≥ II or left ventricular ejection fraction (LVEF)lower
than 50%;
5. Any factors that increase the risk of QTc prolongation or arrhythmias, such as
heart failure, hypokalemia, congenital long QT syndrome, a family history of
long QT syndrome or unexplained sudden death in a first-degree relative under
the age of 40, or concurrent use of any medications known to prolong the QT
interval;
6. uncontrolled hypertension;
16. History of other malignant tumor within 2 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); 17.
No psychological, spiritual potentially hampering compliance with the study protocol
and follow-up schedule; 18. Women who are pregnant or breastfeeding; 19. Any other
reasons deemed by the investigator to render the participant unsuitable for
inclusion in this clinical trial.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Disease Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Liu, MD
Phone:
86-022-23908463
Email:
liuwei@ihcams.ac.cn
Contact backup:
Last name:
Wei Liu, MD
Start date:
May 30, 2024
Completion date:
July 30, 2027
Lead sponsor:
Agency:
Qiu Lugui
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06594640
