Y90 Ibritumomab Tiuxetan Post R-CHOP Chemotherapy for Advanced Stage Follicular Lymphoma (ZEVISS)
This study is currently recruiting participants.
Verified October 2011 by Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. Neil Berinstein, Sunnybrook Health Sciences Centre
First received: August 11, 2011
Last updated: October 4, 2011
Last verified: October 2011
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.
Biological: Y90 Ibritumomab Tiuxetan RIT
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- The primary endpoint for this study is the complete response rate measured 3 months after the dose of 90Y-RIT [ Time Frame: 3 months after the dose of 90Y-RIT ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- toxicities [ Time Frame: entry into trial until 6 weeks post 90Y ibritumomab tiuxetan treatment (week 30) ] [ Designated as safety issue: Yes ]
Toxicity associated with R-CHOP induction and 90Y ibritumomab tiuxetan treatment will be assessed by monitoring the incidence, severity, and type of adverse events. Adverse events will be recorded according to the NCI CTCAE . In addition, changes in physical examination findings, vital signs, and clinical laboratory results (complete blood count, differential, and chemistry) will be documented.
- Conversion of partial responses to complete responses [ Time Frame: 6 weeks post 90Y ibritumomab tiuxetan treatment ] [ Designated as safety issue: No ]
CTT assessment before and after 90Y ibritumomab tiuxetan treatment - Bone marrow aspiration and biopsies in those patients with positive Bone marrows prior to 90Y ibritumomab tiuxetan treatment.
- Minimal residual disease [ Time Frame: For two years post study entry ] [ Designated as safety issue: No ]
Peripheral blood will be assessed every 6 months for the two years from entry into the trial and subjected to PCR analysis for evidence of lymphoma cells with the t(14;18)
- Time to treatment failure [ Time Frame: Two years of the study duration ] [ Designated as safety issue: No ]
Evidence of progression will be assessed every 6 months for two years from study entry clinically and radiologically to determine the date of disease progression
- Overall survival [ Time Frame: two years of study duration ] [ Designated as safety issue: No ]
Survival will be assessed continually throughout the two year study period
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
Experimental: Y90 Ibritumomab Tiuxetan
Addition of Y90 Ibritumomab Tiuxetan RIT to CHOP-R treatment for follicular lymphoma-patients also receive maintenance Rituximab every 3 months for 2 years after the Y90 Ibritumomab Tiuxetan
Biological: Y90 Ibritumomab Tiuxetan RIT
Other Name: Zevalin
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age greater than or equal to 18 years.
- Biopsy demonstration of a CD20+ follicular non-Hodgkin's lymphoma diagnosed according to the World Health Organization (WHO) classification (grade I, II, or IIIa).
- Staging demonstration of advanced stage disease (stage III or IV) according to the Ann Arbor staging system.
- Intermediate or high-risk prognostic score (2-5 points) according to the follicular lymphoma international prognostic index (FLIPI).
- Adequate performance status (less than or equal to 2) according to the Eastern Cooperative Oncology Group (ECOG) (Zubrod) scale.
- No prior radiotherapy or systemic therapy, including chemotherapy or immunotherapy (rituximab).
- Bi-dimensional measurable disease by physical examination or radiographic evaluation (disease measurements at least 1.5 cm x 1.5 cm) or assessable disease on bone marrow evaluation.
- Clinical criteria for therapeutic intervention, as previously reported by Hiddeman, including one of: the presence of B-symptoms, bulky disease (mediastinal lymphomas >7.5 cm or other lymphomas >5 cm in maximal diameter), an impairment of normal hematopoesis with hemoglobin <10g/mm3, granulocytes <1500/mm3, or platelets <100,000/mm3, and/or a rapidly progressive disorder.
- Patient consent must be obtained according to the Sunnybrook Health Sciences Centre Research Ethics Board requirements. A sample consent form is given in Appendix I. The patient must sign the consent form prior to registration.
- Patients must be accessible for treatment and follow up. Patients registered on this trial must complete their therapy with 90Y Ibritumomab Tiuxetan at the participating centre. Induction chemotherapy with R-CHOP should also be completed at the participating centre, but exceptions can be made according to the discretion of the centre's primary investigator.
- Protocol treatment is to begin within 5 working days of patient registration
- Pregnancy or women who intend to breast-feed during the study period.
- Follicular non-Hodgkin's lymphoma grade IIIb histology, according to the World Health Organization (WHO) classification.
- Known human immunodeficiency virus infection or hepatitis B viral infection.
- Life expectancy less than or equal to 3 months, according to physician judgement.
- Evidence of left ventricular (LV) dysfunction (ejection fraction less than or equal to 50%). Demonstration of LV function is required in patients over the age of 60 or in patients with a prior history of hypertension, congestive heart failure, peripheral vascular disease, cerebrovascular disease, coronary artery disease, or cardiac arrhythmia.
- Serum creatinine, alkaline phosphatase, or total bilirubin >2.5 times the upper limit of the normal value, unless clearly related to lymphoma.
- Concurrent uncontrolled medical disease, including severe congestive heart failure, myocardial infarction within 6 months prior to enrollment, severe chronic renal failure, or active infection, with the severity of disease judged according to the discretion of the treating physician.
- Patients with a history of other malignancies, except: (1) adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or (2) other solid tumours curatively treated with no evidence of disease for > 5 years
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446562
|Sunnybrook Health Sciences Centre, Odette Cancer Centre
|Toronto, Ontario, Canada, M4N 3M5 |
|Contact: Mary-Anne Cussen, RN BScN CCRP (416) 480-5846 email@example.com |
|Principal Investigator: Neil L Berinstein, MD, FRCP(C) |
Sunnybrook Health Sciences Centre
||Neil L Berinstein, MD, FRCP(C)
||Sunnybrook Health Sciences Centre, Odette Cancer Centre
No publications provided
||Dr. Neil Berinstein, Medical Oncologist, Sunnybrook Health Sciences Centre
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 11, 2011
||October 4, 2011
||Canada: Health Canada
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs