Phase II Trial of Y90 Ibritumomab Tiuxetan Post Rituximab-Cyclophosphamide, Doxobrubicn, Vincristine and Prednisone (R-CHOP) Chemotherapy for Newly Diagnosed Patients With Advanced Stage Follicular Lymphoma (ZEVISS)

NCT01446562 Phase 2 COMPLETED

The primary objective of this study is to establish in a prospective phase II study the efficacy of 90Yttrium ibritumomab tiuxetan (90Y-RIT) after first line induction immuno-chemotherapy with R-CHOP in patients with high-risk advanced stage follicular non-Hodgkin's lymphoma, as assessed by the complete response rate.

Details

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	Phase 2
Status	COMPLETED
Enrolment	34
Start date	2007-05
Completion	2016-05

Conditions

• Follicular Lymphoma

Interventions

• Y90 Ibritumomab Tiuxetan RIT

Primary outcomes

• The primary endpoint for this study is the complete response rate measured 3 months after the dose of 90Y-RIT — 3 months after the dose of 90Y-RIT
  The primary endpoint for the study is the final complete response (CR) rate, defined according to International Working Group criteria 24, and measured 3 months after completion of the treatment (measured from day 1 of the 90Y-RIT therapy). Hence, CR implies the elimination of all lymphoma manifestations including complete disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms if present before therapy.

Countries

Canada