Y90 Ibritumomab Tiuxetan Post R-CHOP Chemotherapy for Advanced Stage Follicular Lymphoma (ZEVISS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 21, 2014
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs