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

Follicular Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01662102
• Other study ID #: SPI-ZEV-12-302
• Status: Terminated
• Phase: Phase 3
• Start date: December 11, 2012
• Est. completion date: March 5, 2013

Study information

• Verified date: September 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 5, 2013
• Est. primary completion date: March 5, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• Zevalin
Zevalin administered intravenously.
• Rituximab
Rituximab administered intravenously.

Locations

Country	Name	City	State
United States	Northeast Georgia Cancer Care	Athens	Georgia
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Illinois Cancer Specialists	Niles	Illinois
United States	Park Nicollet Institute	Saint Louis Park	Minnesota
United States	21st Century Oncology	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete Response Rate		Up to approximately 2.7 months
Secondary	Event Free Survival	EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).	Up to approximately 2.7 months
Secondary	Time to Progression (TTP)	TTP is defined as the time from randomization to the first disease progression.	Up to approximately 2.7 months
Secondary	Time to Next Anti-Lymphoma Treatment (TTNLT)	TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.	Up to approximately 2.7 months
Secondary	Time to Next Chemotherapy (TTNCT)	TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Participants who respond to treatment and Participants who are lost to follow-up censored at the visit on which the dosing of a new medication was evaluated.	Up to approximately 2.7 months
Secondary	Overall Response Rate (ORR)	Tumor response evaluated according to Cheson criteria at the time of randomization and at the end of the maintenance/observation, post randomization. ORR is defined as the percentage of Participants with a complete response (CR) or a partial response (PR), and compared between treatment groups. Participants with no response evaluation (for any reason) considered as not evaluable (NE).	Up to approximately 2.7 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to death from any cause. In living patients, survival time was censored on the last date participants were known to be alive.	Up to approximately 2.7 months
Secondary	Transformation at First Progression	Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.	Up to approximately 2.7 months
Secondary	Number of Participants With Toxicity	Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.	Up to approximately 2.7 months
Secondary	Number of Participants With Secondary Malignancies		Up to approximately 2.7 months
Secondary	Functional Assessment of Cancer - General (FACT-G)	The FACT-G is a participant rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.	Up to approximately 2.7 months
Secondary	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. High score represented a favourable outcome with a best quality of life for participant.	Up to approximately 2.7 months
Secondary	Pharmacoeconomics (Cost Effectiveness Analysis)	A cost-effectiveness analysis done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis conducted according to a health economic analysis plan independent from this clinical study protocol.	Up to approximately 2.7 months