Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)

NCT ID: NCT01662102

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-11
• Study Completion Date: 2013-03-05

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).

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Zevalin Regimen Consolidation (Group A)

90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).

The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).

Group Type: EXPERIMENTAL

Zevalin

Intervention Type: DRUG

Zevalin administered intravenously.

Rituximab

Intervention Type: DRUG

Rituximab administered intravenously.

Rituximab Maintenance (Group B)

Participants were to receive 375 mg/m\^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

Rituximab administered intravenously.

Interventions

Zevalin

Zevalin administered intravenously.

Intervention Type: DRUG

Rituximab

Rituximab administered intravenously.

Intervention Type: DRUG

Other Intervention Names

90Y-ibritumomab tiuxetan; Rituxan

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%.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Cabanillas, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Thomas Witzig, MD

Role: PRINCIPAL_INVESTIGATOR

The Mayo Clinic & Foundation

Steven E Finkelstein, MD

Role: PRINCIPAL_INVESTIGATOR

GenesisCare USA

Leonard Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Illinois Cancer Specialists - US Oncology

Steven Jubelirer, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Petros Nikolinakos, MD

Role: PRINCIPAL_INVESTIGATOR

Northeast Georgia Cancer Care

Locations

21st Century Oncology

Sun City, Arizona, United States

Northeast Georgia Cancer Care

Athens, Georgia, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Park Nicollet Institute

Saint Louis Park, Minnesota, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

SPI-ZEV-12-302

Identifier Type: -

Identifier Source: org_study_id