A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

Sponsor
Lymphoma Study Association
Study ID
NCT00169156
Phase
PHASE2
Status
Completed

Conditions

  • Untreated T-cell Angioimmunoblastic Lymphoma

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m2 D1
  • Prednisone — DRUG
    40 mg/m2 D1 to D5
  • Doxorubicine — DRUG
    50 mg/m2 D1
  • Cyclophosphamide — DRUG
    750 mg/m2 D1
  • Vincristine — DRUG
    1,4 mg/m2 D1

Study Details

To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

Key Dates

Start date
Dec 31, 2005
Status verified
Mar 2017
Primary completion
Dec 31, 2008
Completion
Nov 30, 2012

Study Design

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

Arms

  • Experimental: Rituximab + CHOP
    Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 8 months (4 cycles of treatment + 4 cycles of consolidation) ]