Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma (FIZZ)
|ClinicalTrials.gov Identifier: NCT01493479|
Recruitment Status : Unknown
Verified December 2011 by The Christie NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : December 16, 2011
Last Update Posted : December 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: 90Y Ibritumomab tiuxetan Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||September 2015|
|Experimental: Fractionated Initial Zevalin||
Drug: 90Y Ibritumomab tiuxetan
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.
Other Name: ZevalinDrug: Rituximab
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.
Other Name: Mabthera
- Overall response rate [ Time Frame: Assessed 3 months post treatment ]According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
- Combined Complete Response rate [ Time Frame: Assessed 3 months post treatment ]According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
- Partial Response Rate [ Time Frame: Assessed 3 months post treatment ]According to Cheson criteria to standardize response for non-Hodgkin's lymphoma, 1999.
- Time to disease progression [ Time Frame: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up ]
- Response duration [ Time Frame: Assessed 3 months post treatment, repeated assessment up to 5 years follow-up ]To be assessed for patients achieving a response, including assessment of overall survival and time until next treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493479
|Centre Hospitalier Universitaire de Lille|
|Centre Hospitalier Universitaire de Nantes|
|Centre Henri Becquerel|
|St George's Hospital|
|London, United Kingdom|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Poole Hospital NHS Foundation Trust|
|Poole, United Kingdom|
|Southampton University Hospital|
|Southampton, United Kingdom|
|Principal Investigator:||Timothy Illidge, Prof||The Christie NHS Foundation Trust|