Phase II study on the feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma having achieved partial or complete remission after induction with R-PECC chemotherapy.
- Conditions
- Aggressive B-cell NHL: FL grade 3b and DLBC
- Registration Number
- NL-OMON24909
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Histologically confirmed aggressive B-cell NHL according to the World Health Organization (WHO) classification: Follicular lymphoma grade 3b or Diffuse large B-cell lymphoma
2. Refractory disease or histologically confirmed first or second relapse(Refractory is defined as no response or partial remission according to CT. Patients in partial response (PR) can only be included in case of positive PET scan or positive biopsy)
Exclusion Criteria
1. Prior allogeneic stem cell transplantation-
2. Prior radioimmunotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - The incidence of grade >=3 adverse events after treatment with 90Y-ibritumomab tiuxetan.<br /><br>- Failure free survival measured from the start of 90Y-ibritumomab tiuxetan
- Secondary Outcome Measures
Name Time Method - Incidence and duration of hypoplasia after treatment with 90Y-ibritumomab tiuxetan<br /><br>- Incidence of adverse events after treatment with 90Y-ibritumomab tiuxetan<br /><br>- Incidence of adverse events after treatment with R-PECC<br /><br>- Percentage of patients treated with R-PECC who proceed to 90Y-ibritumomab tiuxetan treatment<br /><br>- Conversion to PET negative CR after 90Y-ibritumomab tiuxetan treatment of patients who are PET positive before start of 90Y-ibritumomab tiuxetan<br /><br>- Overall survival measured from the start of 90Y-ibritumomab tiuxetan<br /><br>- Response rates to R-PECC and response duration<br /><br>- Failure free survival and overall survival measured from the start of R-PECC<br>