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R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma

NCT02428751 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2015-11-18

No results posted yet for this study

Summary

The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a prolonged circulation time and unique toxicity profile. Previous single arm studies of elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head compared in a randomized study. The aim of this study is to compare the efficacy and safety of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated elderly patients with DLBCL.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

DRUG

Pegylated liposomal doxorubicin

30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

DRUG

Doxorubicin

50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

DRUG

Rituximab

375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle

DRUG

Cyclophophamide

750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

DRUG

Vincristine

1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle

DRUG

Prednisone

100mg/d, PO on day 1-5 of each 21 day cycle

Sponsors & Collaborators

  • Wenqi Jiang

    lead OTHER

Principal Investigators

  • Wen-qi Jiang, M.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-03-31
Completion
2020-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428751 on ClinicalTrials.gov