Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma (FIZZ)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|