The hypothesis to be tested is that the efficacy and toxicity of treatment with 90Y-ibritumomab tiuxetan meets the expectations as described in the protocol.
ID
Bron
Verkorte titel
Aandoening
Non-Hodgkin's lymphoma (NHL), B-Cell lymphoma
Ondersteuning
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Response on FDG-PET (i.e. PET-negative residual masses).
Achtergrond van het onderzoek
Study 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 ¡Ý 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.
Doel van het onderzoek
The hypothesis to be tested is that the efficacy and toxicity of treatment with 90Y-ibritumomab tiuxetan meets the expectations as described in the protocol.
Onderzoeksopzet
At 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.
Onderzoeksproduct en/of interventie
Infusion of Rituximab followed one week later by a second Rituximab infusion and a single dose of 90Y-ibritumomab tiuxetan.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1969 |
NTR-old | NTR2086 |
Ander register | EudraCT number : 2005-003796-20 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |