Zevalin (90Yttrium-ibritumomab tiuxetan)-BEAM and autologous stem cell transplantation or single dose 90Yttrium ibritumomab tiuxetan as consolidation of induction chemotherapy in patients with transformed non-Hodgkin*s lymphoma. ;A phase II clinical trial
- Conditions
- transformed lymphomatransformed non-Hodgkin's lymphoma10025320
- Registration Number
- NL-OMON39525
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
* 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
* 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).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>2 year progression free survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>2 year overall survival<br /><br>time to next treatment<br /><br>conversionrate of PR to CR as measured by PET-CT if in PR before consolidation<br /><br>therapy.<br /><br>recovery of immunoglobins, B-,T-, and NK-cell subsets measured at different<br /><br>time points after consolidation therapy.</p><br>