NCT03022123

Brief Summary

270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modified CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

January 16, 2017

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

January 9, 2017

Last Update Submit

January 13, 2017

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    up to 19 months

Study Arms (2)

pegylated liposomal doxorubicin

EXPERIMENTAL

PL-doxorubicin 35-40 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.

Drug: PL-doxorubicin and epirubicin

Epirubicin

ACTIVE COMPARATOR

Epirubicin 70 mg/m(2) was given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21 days for six courses;Rituximab 375 mg/m(2) was given on day 0.

Drug: PL-doxorubicin and epirubicin

Interventions

PL-doxorubicin and epirubicinDRUG

PL-doxorubicin 35-40 mg/m(2) and epirubicin 70 mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.

Also known as: prednisone, vincristine, cyclophosphamide, rituximab
Epirubicinpegylated liposomal doxorubicin

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years
  • Diagnosis of previously-untreated DLBCL(patients with a transformed untreated low-grade lymphoproliferative disease were accepted)
  • ECOG performance status \< 3 (and higher if due to lym-phoma)
  • No symptomatic cardiac arrythmias or heart failure
  • Acceptable renal, hepatic and pulmonary function
  • Standard laboratory and radiological staging procedures and left ventricular ejection fraction analysis by echocardiography or scintigraphy were required before therapy in all cases
  • The protocol was approved by the ethics review committee of each partici- pating center
  • All patients gave informed written consent.

You may not qualify if:

  • Patients with a previous history of cardiac disease;
  • HIV-HBsAg-HCV positivity, central nervous system involvement or any other major clinicalcondition;
  • Other than lymphoma, which might have precluded a regular therapeutic course, were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

EpirubicinPrednisoneVincristineCyclophosphamideRituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Liu Lihong, archiater

    Hebei Medical University Fourth Hospital

    PRINCIPAL INVESTIGATOR

  • Liu Lihong, archiater

    Hebei Medical University Fourth Hospital

    STUDY DIRECTOR

Central Study Contacts

Liu Lihong, archiater

CONTACT

13831177920

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 16, 2017

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

March 1, 2018

Last Updated

January 16, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)