R-CMOP in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

NCT06594640 | Recruiting Phase 1

• 1 other identifier: IIT2024014
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Mitoxantrone hydrochloride liposome injection; Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (4)

• Phase I:Maximum tolerated dose (MTD)

  Maximum tolerated dose (MTD) of liposomal mitoxantrone hydrochloride in R-CMOP

  Through the last patient complete his DLT observation, assessed up to 21 days

• Phase I: Recommended phaseII dose (RP2D)

  The Recommended Phase II Dose (RP2D) is defined as the optimal dose of liposomal mitoxantrone hydrochloride for use in Phase II trials, as determined by the outcomes of the Phase I study.

  Through the last patient complete his DLT observation, assessed up to 21 days

• Phase II:Complete remission rate (CRR)

  Response is assessed according to the lugano criteria

  up to 2 years

• Phase I: Dose limited toxicities (DLTs)

  adverse events defined as DLT events per protocol

  Through the last patient complete his DLT observation, assessed up to 21 days

Secondary Outcomes (11)

• Phase I: The incidence rates of adverse events (AEs)

  up to 2 years

• Phase I: Objective response rate (ORR)

  up to 2 years

• Phase I: Complete remission rate (CRR)

  up to 2 years

• Phase II: Overall response rate (ORR)

  up to 2 years

• Phase II: Partial response rate (PRR)

  up to 2 years

Study Arms (1)

R-CMOP

EXPERIMENTAL

R-CMOP regimen includes rituximab (R), cyclophosphamide (C), mitoxantrone hydrochloride liposome injection (M), vincristine (O), and prednisone (P). The regimen will be administered every 3 weeks, for a maximum of 6 cycles.

Drug: Mitoxantrone Hydrochloride Liposome; Drug: Rituximab (R); Drug: Cyclophosphamide (CTX); Drug: Vincristin; Drug: Prednisolone

Interventions

Mitoxantrone Hydrochloride Liposome DRUG

assigned dose according to the 3+3 dose-escalation design in part 1, RP2D in part 2, D2

R-CMOP

Rituximab (R) DRUG

375mg/m2, D2

R-CMOP

Cyclophosphamide (CTX) DRUG

750mg/m2, D2

R-CMOP

Vincristin DRUG

1.2mg/m2, maximum 2mg， D2

R-CMOP

Prednisolone DRUG

60mg/m2, D2-6

R-CMOP

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• Histologically confirmed newly diagnosed diffuse large B-cell lymphoma;
• Patients must have been untreated, including chemotherapy, targeted therapy, immunotherapy, radiotherapy;
• There must be at least one measurable lesion per the Lugano2014 criteria；
• For lymph lesion, the long axis must be greater than 1.5cm with 18F-deoxyglucose (18FDG) PET-CT positive；
• Ann Arbor stages II-IV；
• ECOG score 0\~2；
• Expected survival time ≥3 months;
• 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;
• 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;
• Able to understand and comply with the study, and voluntarily sign informed consent; -

You may not qualify if:

• 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；
• transformed indolent lymphoma ;
• Patients with active central nervous system involvement;
• History of hematopoietic stem cell transplantation;
• Have received prior anti-lymphoma treatment, excluding short-term or low-dose corticosteroids.;
• Used any NMPA-approved anticancer herbal medicines or proprietary Chinese medicines within 14 days prior to the first dose;
• History of allergy and contraindications to the same class and excipients of the experimental drug;
• 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;
• Active bacterial or viral infections requiring systemic or intravenous drug treatment.
• History of immunodeficiency, including anti-HIV positive;
• 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);
• syphilis infection;
• 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;
• Patients with interstitial lung disease that requires treatment; 15: A history of severe cardiovascular disease, including but not limited to:
• Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second to third-degree atrioventricular (AV) block;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Disease Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Vincristine; Prednisolone

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lugui Qiu, Professor

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu

CONTACT

+86-022-23608461; liuwei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: May 14, 2025

Record last verified: 2024-09

Locations

CN (1)