R-CHOP Versus R-mini-CEOP in Elderly Patients(>65)With DLBCL

Overview

The study has the purpose to compare R-CHOP versus R-mini-CEOP in elderly patients (>65 years) with Diffuse Large B Cell Lymphoma (DLBCL).

Full Title of Study: “A Randomized Phase III Randomized Study to Compare R-CHOP Versus R-mini-CEOP in Elderly Patients (>65 Years) With Diffuse Large B Cell Lymphoma (DLBCL)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2006

Interventions

  • Drug: Cyclophosphamide
    • 750 mg/mq IV, day 1
  • Drug: Cyclophosphamide
    • 50 mg/mq IV, day 1
  • Drug: Doxorubicin
    • 50 mg/mq IV, day1
  • Drug: Vincristine
    • 1,4 mg/mq (max 2 mg)IV, day 1
  • Drug: Prednisone
    • 75 mg/mq IV, days 1-5
  • Drug: Prednisone
    • 60 mg/mq IV/PO, days 1-5
  • Drug: Epirubicin
    • 50 mg/mq IV, day 1
  • Drug: Vinblastine
    • 5 mg/mq IV, day 1
  • Drug: Rituximab
    • 375 mg/mq IV, day 1
  • Drug: G-CSF
    • 300 µg tot., SC; days 7-11

Arms, Groups and Cohorts

  • Experimental: R-CHOP
    • R-CHOP (every 21 days) for six courses Cyclophosphamide: 750 mg/m2, IV, day 1 Doxorubicin: 50 mg/m2, IV, day 1 Vincristine: 1.4 (max 2) mg/m2, IV, day 1 Prednisone: 75 mg/m2, IV, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11
  • Experimental: R-mini-CEOP
    • R-miniCEOP (every 21 days)for six courses Cyclophosphamide: 50 mg/m2, IV, day 1 Epirubicin: 50 mg/m2, IV, day 1 Vinblastine: 5 mg/m2, IV, day 1 Prednisone: 60 mg/m2, IV/PO, days 1-5 Rituximab: 375 mg/m2, IV, day 1 G-CSF: 300 µg tota, SC; days 7-11

Clinical Trial Outcome Measures

Primary Measures

  • Event Free Survival (EFS)
    • Time Frame: 2 years

Secondary Measures

  • Complete Remission (CR) rate
    • Time Frame: 2 years
  • Disease Free Survival (DFS)
    • Time Frame: 2 years
  • Multidimensional Evaluation Scale for the definition of “frail” and “non frail” patients
    • Time Frame: 2 years

Participating in This Clinical Trial

Inclusion Criteria

1. Patients with untreated DLBCL aged 66 to 80 years without major accompanying diseases and considered as "non frail".

2. Patients were classified as "non frail" (fit) if they had

  • ADL (Activity of Daily Living) score of 6
  • less than three grade 3 Cumulative Illness Rating Score for Geriatrics (CIRS-G) co-morbidities and no grade 4 co-morbidities
  • absence of geriatric syndrome

3. Patients HIV negativity;

4. Concurrent malignancy;

5. Written Informed Consent.

Exclusion Criteria

  • All other patients were classified as "unfit", and were excluded from randomization

Gender Eligibility: All

Minimum Age: 66 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Italiana Linfomi ONLUS
  • Provider of Information About this Clinical Study
    • Francesco Merli, MD, U.O.A. di Ematologia Azienda Ospedaliera S. Maria Nuova
  • Overall Official(s)
    • Francesco Merli, MD, Study Chair, U.O.A. di Ematologia Azienda Ospedale S. Maria Nuova
    • Marilena Bertini, MD, Study Chair, U.O.A. di Ematologia Ospedale Molinette

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