EUCTR2006-007083-28-NL
Active, not recruiting
Not Applicable
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
HOVON foundation0 sites60 target enrollmentMarch 10, 2008
ConditionsAggressive B-cell NHLMedDRA version: 14.1Level: PTClassification code 10003902Term: B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aggressive B-cell NHL
- Sponsor
- HOVON foundation
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligibility criteria for registration, Inclusion criteria R\-PECC induction:
- •\- Histologically confirmed aggressive B\-cell NHL according to the World Health Organization (WHO) classification (see appendix A): Follicular lymphoma grade 3b, 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 al21, 1999\) (see appendix B)
- •\- Age \> 18 years
- •\- WHO performance status 0, 1 or 2 (see appendix E)
- •\- Life expectancy of at least 3 months
Exclusion Criteria
- •Eligibility criteria for registration, Exclusion criteria R\-PECC induction:
- •\- 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
Outcomes
Primary Outcomes
Not specified
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