R-ACVBP and DA-EPOCH-R in Patients With Non-GCB DLBCL

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT03018626
Phase
PHASE3
Status
Unknown

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    rituximab (375 mg/m2) given intravenously (IV) on day 0
  • Etoposide — DRUG
    Etoposide(50 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
  • Doxorubicin — DRUG
    Doxorubicin(10 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
  • Vincristine — DRUG
    Vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
  • Cyclophosphamide — DRUG
    Cyclophosphamide(750 mg/m2)/dayg IV on days 5
  • Prednisone — DRUG
    prednisone (100 mg) given orally bid on days 1 through to 5.
  • Doxorubicin — DRUG
    Doxorubicin (75 mg/m2) given intravenously (IV) on day 1,
  • Cyclophosphamide — DRUG
    Cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1,
  • Vindesine — DRUG
    Vindesine (2 mg/m2) given on days 1 and 5
  • Bleomycin — DRUG
    Bleomycin (10 mg) given IV on days 1 and 5

Study Details

This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse large B-cell lymphoma

Key Dates

Start date
Jul 27, 2017
Status verified
Jul 2017
Primary completion
Jan 31, 2020
Completion
Jan 31, 2021

Study Design

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

Arms

  • Active Comparator: DA-EPOCH-R
    DA-EPOCH-R regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, etoposide(50 mg/m2), doxorubicin(10 mg/m2) and vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours), cyclophosphamide(750 mg/m2)/dayg IV on days 5, prednisone (60 mg/m2) given orally bid on days 1 through to 5.All patients received granulocyte colony-stimulating factor (G-CSF) beginning on day 6 and continued until the ANC was more than 5 × 109/L above the nadir level. The adjustment paradigm was based on the ANC nadir in the previous cycle as previously described(Wilson, Grossbard et al. 2002)
  • Experimental: Modified R-ACVBP
    R-ACVBP regimen: rituximab (375 mg/m2) given intravenously (IV) on day 0, doxorubicin (75 mg/m2) and cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1, vindesine (2 mg/m2) given on days 1 and 5, bleomycin (10 mg) given IV on days 1 and 5, prednisone (60 mg/m2) given orally on days 1 through to 5.

Primary Outcome Measure

Progression-free survival [ Time Frame: 3 years ]

Central Contacts

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