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 NHLlymphoma10025320
- Registration Number
- NL-OMON36830
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
-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)
-Written informed consent
-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)
-Renal dysfunction, serum creatinine 180 umol/l or more or clearance 40 ml/min or less (unless caused by the NHL)
-Active uncontrolled infections
-Patients known to be HIV-positive
-Current or chronic hepatitis B or hepatitis C infection
-Symptomatic NHL localization in the central nervous system (CNS). Lumbal puncture is not required unless CNS involvement with NHL is clinically suspected
-Transformed indolent lymphoma
-Post-transplant lymphoproliferative disorder
-Pregnant or breast-feeding female patients. Negative serum pregnancy test at study is mandatory for female patients of childbearing potential
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Feasibility and safety<br /><br>Primary endpoint<br /><br>- The incidence of grade >2 adverse events after treatment with 90Y-ibritumomab<br /><br>tiuxetan.<br /><br><br /><br>Efficacy<br /><br>Primary endpoint<br /><br>- Failure free survival measured from the start of 90Y-ibritumomab tiuxetan</p><br>
- Secondary Outcome Measures
Name Time Method <p>Feasibility and safety<br /><br>Secondary endpoints<br /><br>- Incidence and duration of hypoplasia after treatment with 90Y-ibritumomab<br /><br>tiuxetan<br /><br>- Incidence of adverse events (any grade) after treatment with 90Y-ibritumomab<br /><br>tiuxetan<br /><br>- Percentage of patients treated with R-PECC who proceed to 90Y-ibritumomab<br /><br>tiuxetan treatment<br /><br>- Incidence of adverse events (any grade) after treatment with R-PECC<br /><br><br /><br>Efficacy<br /><br>Secondary endpoints<br /><br>- Conversion to PET negative CR after 90Y-ibritumomab tiuxetan treatment of<br /><br>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</p><br>