To determine the conversion rate of PR to CR (i.e. PET negativity) after a single dose of 90Y-ibritumomab tiuxetan (a dose of 14.8 MBq/kg or 0.4 mCi/kg, max 1184 MBq or 32mCi) in patients with grade 1-3a, stage II, III or IV follicular lymphoma with…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the conversion rate of PR to CR
Secondary outcome
progression free survival (PFS)
time to next treatment (TTNT)
biological characteristics in bone marrow and stem cell product before and
after a single dose of 90Y-ibritumomab tiuxetan
Background summary
90Y-ibritumomab tiuxetan prolongs PFS if given after first line therapy in
patients with follicular lymphoma. Untill now it has been given in only a few
patients with chemoimmunotherapy as first line, whereas the addition of
rituximab to first line therapy is now standard treatment. Remissionstatus is
assessed by PET-CT scanning because PET is the better predictor of progression
free survival. Because information about the possibiliy of stem cell harvest
after 90Y -ibritumomab tiuxetan is lacking, stem cell mobilisation will be done
before and after the administration of 90Y-ibritumomab tiuxetan.
Study objective
To determine the conversion rate of PR to CR (i.e. PET negativity) after a
single dose of 90Y-ibritumomab tiuxetan (a dose of 14.8 MBq/kg or 0.4 mCi/kg,
max 1184 MBq or 32mCi) in patients with grade 1-3a, stage II, III or IV
follicular lymphoma with PET-positive partial remission on PET-CT scan
following first line R-CVP therapy.
Also, PFS and TTNT will be determined. Biological characteristics of bone
marrow and stem cell harvest before and after a single dose of 90Y-ibritumomab
tiuxetan will be compared.
Study design
Patients in PET positive PR after induction treatment with R-CVP receive a
single dose of 90Y-ibritumomab tiuxetan. If younger than 61 years, stem cell
mobilisation will be performed before this. 3 months after the 90Y-ibritumomab
tiuxetan a PET-CT scan will be made to assess conversion rate, this will only
be repeated after 6 months if CR is not reached at 3 months. Minimal three
months after 90Y-ibritumomab tiuxetan a second stem cell mobilisation will be
performed.
Intervention
a single dose of 90Y-ibritumomab tiuxetan
Study burden and risks
extra PET-CT scans instead of CT scans
once extra stemcell mobilisation
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* Histologically confirmed (according to WHO classification) CD 20 positive follicular lymphoma, grade 1, 2 or 3a, stage II, III or IV (with indication for treatment following local guidelines) of all FLIPI scores.
* Age 18 years or older, for stem cell mobilisation analysis age 18-61 years
* Having received 6-8 courses of 1st line R-CVP therapy
* WHO performance status 0 to 2
* Life expectancy of at least 6 months
* PET positive partial remission on PET-CT scan after 6-8 R-CVP
* Absolute neutrofil count (ANC) 1.5 x 109/l or higher
* Platelet count of 150 x 109/l or higher
* Hb > 6 mmol/l, (transfusion is allowed to achieve this)
* Less than 25% bone marrow involvement after 6-8 R-CVP, measured by bone marrow biopsy.
* Written informed consent obtained according to local guidelines
Exclusion criteria
* Any other anticancer treatment for NHL except the first line R-CVP
* Prolonged cytopenia during first line induction chemotherapy requiring more than 2 weeks delay due to insufficient bone marrow reserve.
* Prior external beam radiotherapy to > 25% of active bone marrow. (involved field or regional)
* Patients who have not recovered from the toxic effects of the first line chemotherapy
* Presence of gastric, central nervous system or testicular localisation at first diagnosis
* Any other malignancy or history of prior malignancy except non-melanoma skin cancer or stage 0 cervical carcinoma within the past 10 years
* Patients with pleural effusion or ascites
* Patients with abnormal liver function ( bili > 1.5 ULN or ALAT > 2.5 ULN)
* Active uncontrolled infection
* Known diagnosis of HIV infection
* Patients with abnormal renal function: serum creatinine > 2.5 ULN
* Known hypersensitivity to murine antibodies or proteins
* G-CSF or GM-CSF therapy within 2 weeks (or 4 weeks if pegylated) prior to adminstration of 90Y-Ibritumomab tiuxetan
* Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter
* Concurrent severe and/or uncontrolled medical disease which could compromise study participation
* Patients who received any investigational drugs or underwent surgery less than 4 weeks before entry in this study or who have as yet not recovered from the side-effects of such treatment.
* Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of this study
* Patients unwilling or unable to comply with the protocol
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012944-17-NL |
| CCMO | NL28368.029.09 |