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Efficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg)90Y-ibritumomab tiuxetan ("Zevalin") in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission following first-line R-CHOP therapy. A Phase II clinical trial (HOVON 77).


- candidate number6677
- NTR NumberNTR2086
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2009
- Secondary IDs2005-003796-20  EudraCT number
- Public TitleEfficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg)90Y-ibritumomab tiuxetan ("Zevalin") in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission following first-line R-CHOP therapy. A Phase II clinical trial (HOVON 77).
- Scientific TitleEfficacy and safety of a single dose of 14.8 MBq/kg (0.4 mCi/kg)90Y-ibritumomab tiuxetan ("Zevalin") in elderly patients with diffuse large B-cell lymphoma and FDG-PET positive partial remission following first-line R-CHOP therapy. A Phase II clinical trial (HOVON 77).
- ACRONYMHOVON 77 NHL
- hypothesisThe hypothesis to be tested is that the efficacy and toxicity of treatment with 90Y-ibritumomab tiuxetan meets the expectations as described in the protocol.
- Healt Condition(s) or Problem(s) studiedNon Hodkin's lymfoma (NHL), B-Cell lymphoma
- Inclusion criteria1. Age >= 60 years old;
2. WHO performance status of 0-2;
3. Life expectancy of at least 3 months;
4. Histologically confirmed CD20 positive Diffuse large B-cell lymphoma (DLBCL), according to the WHO classification;
5. First-line induction treatment with R-CHOP or R-CHOP-like chemotherapy (only CHOP in combination with rituximab; CHOP14 and CHOP21 are both allowed);
6. Partial response on CT-scans after first-line treatment, with measurable disease;
7. PET-positive residual mass;
8. Patient is not eligible for high dose chemotherapy followed by autologous stem cell transplantation;
9. Less than 25% bone marrow involvement at the end of first-line treatment during PR analysis (measurement in a representative bone marrow biopsy);
10. Absolute neutrophil count (ANC) >= 1.5x10^9/l;
11. Hemoglobin (Hb) >= 6 mmol/l;
12. Platelets >= 150 x 10^9/l;
13. Written informed consent obtained according to local guidelines.
- Exclusion criteria1. Hypoplastic bone marrow at biopsy;
2. Prolonged pancytopenia during induction chemotherapy and delayed courses during R-CHOP induction (more than two weeks delay due to insufficient bone marrow reserve);
3. Known hypersensitivity to murine antibodies or proteins;
4. Significant splenomegaly;
5. Patients with abnormal liver function (total bilirubin > 2.0 x ULN);
6. Patients with abnormal renal function (serum creatinine > 2.0 x ULN);
7. Presence of CNS involvement by NHL;
8. Presence of any other active neoplasms or history of prior malignancy, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma during the past 5 years;
9. More than one prior R-CHOP or R-CHOP-like chemotherapy regimen for DLBCL;
10. Patients who have received prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional);
11. Patients who have received G-CSF or GM-CSF therapy within two weeks prior to study enrollment;
12. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study;
13. Patients who have received biologic therapy, immunotherapy, R-CHOP(-like) chemotherapy, surgery, or an investigational drugs less than 4 weeks prior to first day of study treatment or who have not recovered from the toxic effects of such therapy;
14. Patients who have received systemic corticosteroids at doses higher than 20 mg/day prednisolone or equivalent less than 2 weeks prior to 90Y-ibritumomab tiuxetan administration;
15. Known diagnosis of HIV infection;
16. Patients unwilling or unable to comply with the protocol.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 5-jan-2006
- planned closingdate1-jan-2010
- Target number of participants40
- InterventionsInfusion of Rituximab followed one week later by a second Rituximab infusion and a single dose of 90Y-ibritumomab tiuxetan.
- Primary outcomeResponse on FDG-PET (i.e. PET-negative residual masses).
- Secondary outcome1. Progression-free survival;
2. Overall survival;
3. Toxicity CTC AE grade 3-4.
- TimepointsAt entry, 3 months after treatment, 6 months after treatment or at time of disease progression, in FU every 3 months during first 2 years, every 6 months during the next 2 years and annually thereafter.
- Trial web sitewww.hovon.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J.M. Zijlstra
- CONTACT for SCIENTIFIC QUERIES J.M. Zijlstra
- Sponsor/Initiator HOVON Data Center
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF), HOVON, Bayer Schering Pharma B.V.
- PublicationsN/A
- Brief summaryStudy phase: Phase II.
Study objective: Evaluation of efficacy and safety of 90Y-ibritumomab tiuxetan.
Patient population: Patients with Diffuse Large B-Cell lymphoma, CD20-positive, age 60 years and good WHO performance status (0,1,2), with PET-positive PR after R-CHOP induction chemotherapy.
Study design: Prospective, multicenter, open label, non-randomized.
Duration of treatment: Infusion of rituximab followed 1 week later by a second rituximab infusion and a single dose of 90Y-ibritumomab tiuxetan.
- Main changes (audit trail)
- RECORD29-okt-2009 - 5-nov-2009


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