Y90 Ibritumomab Tiuxetan Post R-CHOP Chemotherapy for Advanced Stage Follicular Lymphoma

NCT01446562 | Completed Phase 2

• 1 other identifier: ZEVISS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 in patients with high-risk advanced stage follicular non-Hodgkin's lymphoma, as assessed by the complete response rate.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for this study is the complete response rate measured 3 months after the dose of 90Y-RIT

  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.

  3 months after the dose of 90Y-RIT

Secondary Outcomes (5)

• toxicities

  entry into trial until 6 weeks post 90Y ibritumomab tiuxetan treatment (week 30)

• Conversion of partial responses to complete responses

  6 weeks post 90Y ibritumomab tiuxetan treatment

• Minimal residual disease

  For two years post study entry

• Time to treatment failure

  Two years of the study duration

• Overall survival

  two years of study duration

Study Arms (1)

Y90 Ibritumomab Tiuxetan

EXPERIMENTAL

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

Interventions

Y90 Ibritumomab Tiuxetan RIT BIOLOGICAL

40 mCi/kg

Also known as: Zevalin

Y90 Ibritumomab Tiuxetan

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• Berinstein NL, Pennell NM, Weerasinghe R, Buckstein R, Piliotis E, Imrie KR, Chodirker L, Cussen MA, Miles E, Reis MD, Ghorab Z, Cheung MC. Management of newly diagnosed high-risk and intermediate-risk follicular lymphoma with 90 Y ibritumomab tiuxetan in a phase II study. Hematol Oncol. 2018 Apr 30. doi: 10.1002/hon.2513. Online ahead of print.

  PMID: 29709062 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

ibritumomab tiuxetan

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

Study Officials

• Neil L Berinstein, MD, FRCP(C)

  Sunnybrook Health Sciences Centre, Odette Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: October 5, 2011
• Study Start: May 1, 2007
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

CA (1)