NCT05040555

Brief Summary

A single-center, prospective clinical study to evaluate the efficacy and safety of R-CDOP (Rituximab, Cyclophosphamide, Doxorubicin hydrochloride liposome, Vindesine, Prednisone ) in the treatment of newly diagnosed high tumor burden non-Hodgkin's lymphoma, which has previously shown promising efficacy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Aug 2021Sep 2028

Study Start

First participant enrolled

August 30, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Expected
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

August 31, 2021

Last Update Submit

September 15, 2021

Conditions

Diffuse Large B Cell LymphomaFollicular Lymphoma Grade 3B

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Percentage of Complete remission (CR), and Partial remission (PR), referred to Lugano 2014.

    24 months

Secondary Outcomes (4)

  • Disease Control Rate

    24 months

  • Progression-free survival

    24 months

  • Overall survival

    60 months

  • Adverse Events

    24 months

Study Arms (1)

R-CDOP

EXPERIMENTAL

Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1\~5.

Combination Product: R-CDOP

Interventions

R-CDOPCOMBINATION_PRODUCT

Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1\~5.

R-CDOP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically immunohistochemistry and imaging confirmed diffuse large B-cell lymphoma or follicular lymphoma grade 3B;
  • Has at least one evaluable or measurable lesion according to Lugano response criteria;
  • Patients with at least one of the following high tumor burden Involvement of at least 3 nodal sites (each with a diameter greater than 3 cm); nodal or extranodal mass \> 7cm in its greater diameter; Hepatomegaly and splenomegaly (infiltration confirmed by PET-CT; Spleen: female \> 15cm, male \> 16cm); Pleural/peritoneal effusion; Lactate dehydrogenase (LDH) three times the upper limit of normal; PET-CT TMTV \>220cm3;
  • Patients previously untreated;
  • Patients aged over 18 and under 75 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0\~2;
  • International Prognostic Index (IPI) score \> 1, or with extranodal mass diameter ≥7cm;
  • Life expectancy ≥ 6 months;
  • Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
  • Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

You may not qualify if:

  • Pregnant or lactation and patients of childbearing age who do not want to take contraceptive measures;
  • Abnormal liver function \[total bilirubin \> 1.5 times of the upper limit of normal value; Alanine aminotransferase/Aspartate aminotransferase (ALT / AST) \> 2.5 times of upper limit of normal value for patients without liver metastasis ; ALT / AST \> 5 times of upper limit of normal value for patients with liver metastasis \], abnormal renal function (serum creatinine \> 1.5 times of upper limit of normal value) ;
  • Absolute Neutrophil Count (ANC)\<1.5×10\^9/L or Platelet (PLT)\< 75 × 10\^9/L;
  • Hypersensitivity to any study drug or its ingredients;
  • Patients with significant and uncontrolled cardiovascular disease or history;
  • Persons with mental disorders/unable to obtain informed consent;
  • Lymphoma infiltrates the central nervous system;
  • Previous history of malignant tumor;
  • HIV infection; HBV infection (HBV-DNA\> 2000 IU/ml);HCV infection (HCV-RNA\>200 IU/ml);
  • The investigator determined not suitable to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Ou BAI, doctor

CONTACT

13039046656oubai16@163.com

Study Design

Study Type
interventional
Phase
not applicable
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

August 31, 2021

First Posted

September 10, 2021

Study Start

August 30, 2021

Primary Completion

September 1, 2023

Study Completion (Estimated)

September 1, 2028

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)