Health TrialsbyHealthPanel

CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma

ConditionNHL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This is a prospective, single arm, multicenter study to evaluate the safety and efficacy of CMOP±R in patients with newly diagnosed non-Hodgkin's lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients fully understand this study, voluntarily participate and sign the informed consent (ICF);

Age: 18-75 years old;

Expected survival time ≥ 3 months;

Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma;

Disqualifiers

Subjects have previously received anthracyclic drug pretreatment;

Hypersensitivity to any study drug or its components;

Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);

Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval >480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • CMOP±R

    Drug

    Drug: Mitoxantrone hydrochloride liposome Mitoxantrone hydrochloride liposome (18 mg/m\^2) on day 1, every 4 weeks; Drug: Cyclophosphamide Cyclophosphamide(750 mg/m\^2) on day 1, every 4 weeks; Drug: Vincristine Vincristine (1.4mg/ m2，Max dose 2mg) will be administered on day 1(Or at the discretion of the investigator, use other vinblastine drugs with the same mechanism, such as vindesine 2-3 mg/m2 on day 1), every 4 weeks; Drug: Prednisone Prednisone (100 mg) will be taken orally from day 1-5(Or equivalent dose of dexamethasone at 15mg), every 4 weeks; Drug: Rituximab Rituximab (375mg/m\^2) on day 0, every 4 weeks, only with CD20-positive lymphomas are evaluated by the investigator.

Treatment groups

197 Participants
are divided into 1 treatment group
Group A: CMOP±RExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete Response Rate (CRR)

Response is assessed according to the 2014 lugano criteria.Percentage of participants with complete response was determined on 2014 Lugano criteria.

Time frame
3 years

Secondary outcomes

1

Overall Response Rate (ORR)

Response is assessed according to the 2014 lugano criteria.The total percentage of patients with complete response（CR ）and partial response（PR).

Time frame
3 years
2

Progression-Free-Survival (PFS)

From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.Progression-free survival (PFS) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated.

Time frame
3 years
3

Duration of Response (DOR)

The time between meeting the criteria for treatment effectiveness (first recorded complete or partial response) and the first clear recurrence or progression.Duration of response (DoR) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated.

Time frame
3 years
4

Overall survival (OS)

From the date of inclusion to date of death, irrespective of cause.Overall survival (OS) was analyzed using Kaplan-Meier method, and 95% bilateral confidence intervals were calculated.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
Apply now