Status:
COMPLETED
Y90 Ibritumomab Tiuxetan Post R-CHOP Chemotherapy for Advanced Stage Follicular Lymphoma
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This is a prospective, non-randomized, open label, single-centre phase II trial of R-CHOP followed by 90Y-RIT in patients with previously untreated, high-risk, advanced stage follicular non-Hodgkin's ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01446562
Start Date
May 1 2007
End Date
May 1 2016
Last Update
June 17 2016
Active Locations (1)
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1
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5