The objective of the study is to determine the effectivity of this consolidation treatment, as well as the conversion rate of PR to CR in patients in PR before consolidation and the effect on the immunological recovery.
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
2 year progression free survival.
Secondary outcome
2 year overall survival
time to next treatment
conversionrate of PR to CR as measured by PET-CT if in PR before consolidation
therapy.
recovery of immunoglobins, B-,T-, and NK-cell subsets measured at different
time points after consolidation therapy.
Background summary
Transformed lymphoma has a very short progression free survival after treatment
with chemo-immunotherapy only. Consolidation of remission-induction is thus
necessary. In the VUmc patients with transformed lymphoma receive consolidation
treatment with high dose chemotherapy (BEAM) followed by autologous stem cell
transplantation. The effect of this consolidation treatment can be enhanced by
adding 90Y-ibritumomab tiuxetan, which has been used in other aggressive
lymphomas with inferior prognosis. (ref: Shimoni Exp Hematol 2007, blz 534-540)
In patients not eligible for autologous stem cell transplantation,
consolidation therapy with single dose 90Y-ibritumomab tiuxetan can most likely
improve PFS without inacceptable toxicity. (ref: Zinzani Ann Oncol 2008, blz
769-773)
Study objective
The objective of the study is to determine the effectivity of this
consolidation treatment, as well as the conversion rate of PR to CR in patients
in PR before consolidation and the effect on the immunological recovery.
Study design
If patients with a first diagnosis of transformed lymphoma reach a CR or PR
assessed by PET-CT scan after induction with R-CHOP or R-DHAP,R-VIM, R-DHAP
they can be consolidated with 90Yttrium ibritumomab tiuxetan combined with BEAM
and followed byautologous stem cell transplantation if 18-71 years old, or with
single dose 90Yttrium ibritumomab tiuxetan if ineligible for stem cell
transplantation or older than 70 years.
Study burden and risks
Patients undergo 1 extra PET-CT scan according to protocol for final evaluation.
They have to give more blood samples for analysis, although drawing the blood
can be done during routine laboratory investigations.
They undergo 1 extra bone marrow aspirate and biopsy after two years for final
evaluation.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* First diagnosis of transformation of lymphoma;* Histologically confirmed CD20 positive transformed B cell NHL lymphoma, according to the WHO classification 2008 , stage I-IV. ;* For consolidation with AuSCT after Z-BEAM: age 18-71 years old;* For single dose 90Y-ibritumomab tiuxetan: older than 70 years and 18-71 years but ineligible for autologous stem cell transplantation ;* WHO performance status of 0-2 (Appendix C);* Life expectancy of at least 3 months;* Induction treatment with R-CHOP or R-DHAP-VIM-DHAP;* CR defined as disappearance of all evidence of disease on PET-CT or PR defined as a reduction of tumor size of more than 50% and decreasing FDG-avidity on PET-CT after induction consisting of rituximab containing polychemotherapy. (see appendix A);* Absense of PET positive bulky disease after induction treatment defined as a lesion larger than 5 cm;* Less than 25% bone marrow involvement at the end of induction treatment (measurement in a representative bone marrow biopsy) ;* For AuSCT: Stem cells harvested: a minimum of 2 x 106 CD34+ cells/kg ;* For single dose 90Y-ibritumomab tiuxetan: ANC * 1.5 x 109/l and platelets * 100 x 109/l;* Written informed consent obtained according to local guidelines
Exclusion criteria
* Known hypersensitivity to murine antibodies or proteins;* 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;* Patients with abnormal liver function (total bilirubin > 2.0 x ULN);* Presence of CNS involvement ;* Patients with pleural effusion or ascites after induction therapy;* Patients who have received G-CSF or GM-CSF therapy within two weeks prior to study enrollment;* 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 (i.e. 90Yttrium ibritumomab tiuxetan + AuSCT) or who have not recovered from the toxic effects of such therapy;* 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;* Known diagnosis of HIV infection;* Patients unwilling or unable to comply with the protocol;Additional exclusion criteria for autologous SCT:;* Unfit for high dose chemotherapy followed by autologous stem cell transplantation due to physical or mental condition.;Additional exclusion criteria for single dose 90Y-ibritumomab tiuxetan;* Patients who have received prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional).
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 | EUCTR2010-019659-22-NL |
| CCMO | NL31654.029.10 |