Clinical trial NCT01662102: Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)
Official title: An Open-Label, Multicenter, Randomized Study in Previously Untreated Follicular Lymphoma Patients to Evaluate the Efficacy of Consolidation With Zevalin® Versus Maintenance Treatment With Rituximab After Initial Therapeutic Response to Rituximab Plus Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Follicular Lymphoma
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.

Detailed description: This is an open-label, multicenter and randomized study. Participants registered after response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial response (PR) or complete response (CR) following R-chemotherapy eligible for randomization to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months, or rituximab maintenance for 24 months. After the observation/maintenance period, patients follow up for 5 years.

This study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 months).

Eligibility criteria: Inclusion Criteria:

* 18 to 75 years of age.
* Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe d'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.
* Achieved a response to induction treatment with either rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14), rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or rituximab-bendamustine (R-B) (4 to 6 cycles).
* Must have completed all doses of the induction treatment, except for the modifications allowed in the protocol.

Exclusion Criteria:

* Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma \[FL\]).
* Grade 3b follicular lymphoma.
* Primary follicular lymphoma of the skin or gastrointestinal tract.
* Previous treatment of follicular lymphoma.
* Altered renal and hepatic function.
* Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
* Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
* Life expectancy \< 6.
* Must have:

  * Platelet count ≥ 100x10\^9/L.
  * Bone marrow infiltration \<25%.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Up to approximately 2.7 months
Secondary outcomes:
measure: Complete Response Rate
timeFrame: Up to approximately 2.7 months
measure: Event Free Survival
timeFrame: Up to approximately 2.7 months
measure: Time to Progression (TTP)
timeFrame: Up to approximately 2.7 months
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
timeFrame: Up to approximately 2.7 months
measure: Time to Next Chemotherapy (TTNCT)
timeFrame: Up to approximately 2.7 months
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 2.7 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 2.7 months
measure: Transformation at First Progression
timeFrame: Up to approximately 2.7 months
measure: Number of Participants With Toxicity
timeFrame: Up to approximately 2.7 months
measure: Number of Participants With Secondary Malignancies
timeFrame: Up to approximately 2.7 months
measure: Functional Assessment of Cancer - General (FACT-G)
timeFrame: Up to approximately 2.7 months
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Up to approximately 2.7 months
measure: Pharmacoeconomics (Cost Effectiveness Analysis)
timeFrame: Up to approximately 2.7 months
Other outcomes:
Locations:
city: Sun City
country: United States
facility: 21st Century Oncology
state: Arizona
city: Athens
country: United States
facility: Northeast Georgia Cancer Care
state: Georgia
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Fernando Cabanillas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Mayo Clinic & Foundation
name: Thomas Witzig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GenesisCare USA
name: Steven E Finkelstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Illinois Cancer Specialists - US Oncology
name: Leonard Klein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Steven Jubelirer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northeast Georgia Cancer Care
name: Petros Nikolinakos, MD
role: PRINCIPAL_INVESTIGATOR
References: