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

NCT01662102 | Terminated Phase 3 Results

• 1 other identifier: SPI-ZEV-12-302
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 5

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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).

  Up to approximately 2.7 months

Secondary Outcomes (13)

• Complete Response Rate

  Up to approximately 2.7 months

• Event Free Survival

  Up to approximately 2.7 months

• Time to Progression (TTP)

  Up to approximately 2.7 months

• Time to Next Anti-Lymphoma Treatment (TTNLT)

  Up to approximately 2.7 months

• Time to Next Chemotherapy (TTNCT)

  Up to approximately 2.7 months

Study Arms (2)

Zevalin Regimen Consolidation (Group A)

EXPERIMENTAL

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).

Drug: Zevalin; Drug: Rituximab

Rituximab Maintenance (Group B)

ACTIVE COMPARATOR

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).

Drug: Rituximab

Interventions

Zevalin DRUG

Zevalin administered intravenously.

Also known as: 90Y-ibritumomab tiuxetan

Zevalin Regimen Consolidation (Group A)

Rituximab DRUG

Rituximab administered intravenously.

Also known as: Rituxan

Rituximab Maintenance (Group B); Zevalin Regimen Consolidation (Group A)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (5)

21st Century Oncology

Sun City, Arizona, 85351, United States

Location

Northeast Georgia Cancer Care

Athens, Georgia, 30607, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Park Nicollet Institute

Saint Louis Park, Minnesota, 55426, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

ibritumomab tiuxetan; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Gajanan Bhat, PhD
• Organization: Spectrum Pharmaceuticals

Gajanan.Bhat@sppirx.com

949-743-9219

Study Officials

• Fernando Cabanillas, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Thomas Witzig, MD

  The Mayo Clinic & Foundation

  PRINCIPAL INVESTIGATOR

• Steven E Finkelstein, MD

  GenesisCare USA

  PRINCIPAL INVESTIGATOR

• Leonard Klein, MD

  Illinois Cancer Specialists - US Oncology

  PRINCIPAL INVESTIGATOR

• Steven Jubelirer, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Petros Nikolinakos, MD

  Northeast Georgia Cancer Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 10, 2012
• Study Start: December 11, 2012
• Primary Completion: March 5, 2013
• Study Completion: March 5, 2013
• Last Updated: October 4, 2021
• Results First Posted: January 11, 2016

Record last verified: 2021-09

Locations

US (5)