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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.


- candidate number3625
- NTR NumberNTR1380
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2008
- Secondary IDsH085 
- Public TitlePhase 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.
- Scientific TitlePhase 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.
- ACRONYMHOVON 85 NHL
- hypothesisAddition of 90Y-ibritumomab tiuxetan after R-PECC is feasible and the efficacy meets expectations as described in the protocol.
- Healt Condition(s) or Problem(s) studiedNon Hodkin's lymfoma (NHL), Chemotherapy, B-Cell lymphoma
- Inclusion criteria1. 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)
3. 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)
4. 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 al, 1999)
5. Age > 18 years
6. WHO performance status 0, 1 or 2
7. Life expectancy of at least 3 months
8. Absolute neutrophil count > 1.5 x 109/l and platelet count > 100 x 109/l (unless caused by NHL infiltration in the bone marrow)
9. Written informed consent
- Exclusion criteria1. Prior allogeneic stem cell transplantation-
2. Prior radioimmunotherapy
3. 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
4. Eligibility for ASCT- ASCT within 12 months of study entry
5. Investigational drugs within 4 weeks prior to entry on this study or persistent toxic side effects of such therapy
6. Treatment with external-beam radiation therapy to more than 25% of active bone marrow
7. A history of intolerance to rituximab
8. 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
9. Hepatic dysfunction, bilirubin or transaminases >= 2.5 x upper normal limit (unless caused by the NHL)
10. Renal dysfunction, serum creatinine >=180 mmol/l or clearance <= 40 ml/min (unless caused by the NHL)
11. Active uncontrolled infections
12. Patients known to be HIV-positive
13. Current or chronic hepatitis B or hepatitis C infection
14. Symptomatic NHL localization in the central nervous system (CNS). Lumbal puncture is not required unless CNS involvement with NHL is clinically suspected
15. Transformed indolent lymphoma
16. Post-transplant lymphoproliferative disorder
17. Pregnant or breast-feeding female patients. Negative serum pregnancy test at study is mandatory for female patients of childbearing potential
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate31-dec-2009
- Target number of participants60
- InterventionsPatients will be treated with R-PECC (rituximab, lomustine, etoposide, chlorambucil, prednisone) and 90Y-ibritumomab tiuxetan.
All patients, who have not attained at least a stable disease after 2 cycles of R-PECC and a PR after 4 cycles of R-PECC, will go off protocol treatment.
Patients in PR or CR after 4 cycles of R-PECC will be treated with a single dose of 90Y-ibritumomab tiuxetan.
A cytoreductive pre-phase is permitted.
- Primary outcome- The incidence of grade >=3 adverse events after treatment with 90Y-ibritumomab tiuxetan.
- Failure free survival measured from the start of 90Y-ibritumomab tiuxetan
- Secondary outcome- Incidence and duration of hypoplasia after treatment with 90Y-ibritumomab tiuxetan
- Incidence of adverse events after treatment with 90Y-ibritumomab tiuxetan
- Incidence of adverse events after treatment with R-PECC
- Percentage of patients treated with R-PECC who proceed to 90Y-ibritumomab tiuxetan treatment
- Conversion to PET negative CR after 90Y-ibritumomab tiuxetan treatment of patients who are PET positive before start of 90Y-ibritumomab tiuxetan
- Overall survival measured from the start of 90Y-ibritumomab tiuxetan
- Response rates to R-PECC and response duration
- Failure free survival and overall survival measured from the start of R-PECC
- Timepoints- prior to start treatment - after 2 cycles of R-PECC
- after 4 cycles of R-PECC
- after 90 Y-ibritumomab tiuxetan treatment
- in follow-up every 2 months during the first year, every 4 months during the second year and every 6 months thereafter
- Trial web sitehttp://www.hovon.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.J. Lugtenburg
- CONTACT for SCIENTIFIC QUERIESDr. P.J. Lugtenburg
- Sponsor/Initiator Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- Funding
(Source(s) of Monetary or Material Support)
Amgen, Dutch Cancer Society, Roche Nederland BV, Johnson&Johnson-Orthobiotech
- PublicationsN/A
- Brief summaryStudy phase: II
Study objective:

Evaluation of feasibility and efficacy of consolidation with 90Y-ibritumomab tiuxetan in patients with relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma (NHL) having achieved partial or complete remission after induction with R-PECC chemotherapy

Patient population:
Patients with histologically confirmed CD20 positive aggressive NHL (FL grade 3b, DLBCL) refractory or in first or second relapse, age > 18 years with WHO performance status 0-2, after / not eligible for autologous stem cell transplantation (ASCT)

Study design:
Prospective, multicenter, non-randomized

Duration of treatment:
Expected duration of treatment is about 5-6 months
- Main changes (audit trail)
- RECORD15-jul-2008 - 3-aug-2008


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