A Phase 2 interventional study of 90Y Ibritumomab tiuxetan and Rituximab in Follicular Lymphoma, sponsored by The Christie NHS Foundation Trust. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by The Christie NHS Foundation Trust · Phase 2, Interventional, and Treatment
90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 76 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →The Christie NHS Foundation Trust is the lead sponsor of 99 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with at least one of the following symptoms requiring initiation of treatment: (as outlined by the modified BNLI/GELF criteria below)
Exclusion Criteria:
Drug: 90Y Ibritumomab tiuxetan · Drug: Rituximab
2 x iv infusions of 11.1 MBq/kg. 1st infusion at week 1, 2nd during weeks 9-13. 2nd infusion may be reduced to 7.4MBq/kg in the case of grade 3 haematological toxicity following the 1st infusion.
Also known as: Zevalin
All patients receive 2 x iv infusions of 250 mg/m2 Rituximab given 7-8 days apart prior to each zevalin infusion. The 2nd rituximab infusion is given immediately prior to Zevalin. In addition patients with greater than 20% bone marrow involvement at screening receive rituximab pretreatment prior to entering the main treatment phase of the trial, consisting of 4 x weekly iv doses of rituximab(375 mg/m2). This is followed by a repeat bone marrow biopsy, bone marrow involvement must have fallen to \<= 20% to enter the main treatment phase of the trial.
Also known as: Mabthera
Overall response rate
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Time frame: Assessed 3 months post treatment
Combined Complete Response rate
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Time frame: Assessed 3 months post treatment
Partial Response Rate
According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
Time frame: Assessed 3 months post treatment
Time to disease progression
Time frame: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up
Response duration
To be assessed for patients achieving a response, including assessment of overall survival and time until next treatment.
Time frame: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Christie NHS Foundation Trust