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

Sponsor
Wenqi Jiang
Study ID
NCT02428751
Phase
PHASE3
Status
Unknown

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Pegylated liposomal doxorubicin — DRUG
    30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
  • Doxorubicin — DRUG
    50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
  • Rituximab — DRUG
    375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle
  • Cyclophophamide — DRUG
    750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
  • Vincristine — DRUG
    1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle
  • Prednisone — DRUG
    100mg/d, PO on day 1-5 of each 21 day cycle

Study Details

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.

Key Dates

Start date
Sep 30, 2015
Status verified
Nov 2015
Primary completion
Mar 31, 2020
Completion
May 31, 2020

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: R-CHOP
    This group received R-CHOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Doxorubicin, 50mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
  • Experimental: R-CDOP
    This group received R-CDOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Pegylated liposomal doxorubicin, 30mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.

Primary Outcome Measure

event-free survival (EFS) [ Time Frame: two year ]

Central Contacts

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