Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT00842595
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    6 courses every 28 days
  • vinorelbine — DRUG
    6 courses every 28 days
  • ifosfamide — DRUG
    6 courses every 28 days
  • Mitoxantrone — DRUG
    6 courses every 28 days
  • Prednisone — DRUG
    6 courses every 28 days

Study Details

The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma

Key Dates

Start date
Dec 31, 2003
Status verified
Jul 2010
Primary completion
Nov 30, 2009
Completion
May 31, 2010

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R NIMP
    (Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5

Primary Outcome Measure

Complete remission rate [ Time Frame: CR AFTER 3 R NIMP COURSES ]

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