NL-OMON36830
Recruiting
Phase 2
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. - HOVON 85 NH
HOVO0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Aggressive B-cell NHL
- Sponsor
- HOVO
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Histologically confirmed aggressive B\-cell NHL according to the World Health Organization (WHO) classification (see appendix A):
- •Follicular lymphoma grade 3b or Diffuse large B\-cell lymphoma
- •\-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)
- •\-CD20 positive (assessed at 1st diagnosis or from fresh histology at confirmation of relapse or immunophenotyping of circulating CD20\-positive NHL cells from peripheral blood)
- •\-Current measurable disease, i.e. measurable in two perpendicular dimensions on physical examination or computerized tomography (CT) scan using standardized response criteria for NHL (Cheson et al19, 1999\) (see appendix B)
- •\-Age 18 years or older
- •\-WHO performance status 0, 1 or 2 (see appendix E)
- •\-Life expectancy of at least 3 months
- •\-Absolute neutrophil count \>1\.5 x10^9/l and platelet count \>100 x10^9/l (unless caused by NHL infiltration in the bone marrow)
Exclusion Criteria
- •\-Prior allogeneic stem cell transplantation
- •\-Prior radioimmunotherapy
- •\-Patients who have received chemotherapy or radiotherapy within 6 weeks prior to study entry or who have not recovered from toxicities related to prior therapies
- •\-Eligibility for ASCT
- •\-ASCT within 12 months of study entry
- •\-Investigational drugs within 4 weeks prior to entry on this study or persistent toxic side effects of such therapy
- •\-Treatment with external\-beam radiation therapy to more than 25% of active bone marrow (see appendix F)
- •\-A history of intolerance to rituximab
- •\-Severe cardiac, pulmonary, neurological, psychiatric or metabolic disease which could compromise participation in the study, or serious underlying medical conditions which could impair the ability of the patient to participate in the trial
- •\-Hepatic dysfunction, bilirubin or transaminases 2\.5x upper normal limit or higher (unless caused by the NHL)
Outcomes
Primary Outcomes
Not specified
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