Status:
COMPLETED
Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Bayer
Conditions:
Lymphoma, Large Cell, Diffuse
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-do...
Eligibility Criteria
Inclusion
- Aged from 18 to 65 years.
- Patient with pathologically proven, high grade B-cell Lymphoma CD 20 positive (WHO classification) :
- Diffuse large B cell lymphoma.
- Adverse prognostic factors IPI\>1
- In Complete Remission, or partial response to first line treatment.
- Previously treated with chemotherapy regimen containing rituximab: R CHOP or R ACVBP
- Chemo-sensitive disease
- PET Scan prior transplant
- Eligible for autologous stem cell transplantation
- With a minimum life expectancy of 3 months.
- Negative HIV, HBV and HCV serologies (in the last 4 weeks except after vaccination).
- Having previously signed a written informed consent.
Exclusion
- Histological transformation in diffuse large B cell lymphoma, any type of low grade lymphoma
- More than one line of treatment. Prior transplantation. Prior exposure to Zevalin
- Central nervous system or meningeal involvement by lymphoma.
- Contraindication to any drug contained in the chemotherapy regimen.
- Any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the IDB).
- Poor renal function (creatinin level up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor hepatic function (total bilirubin level up to 30 micro mol/l, transaminases up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils less than 1.5 G/l or platelets less than 100 G/l
- Large bone marrow irradiation more than 40percent.
- Bone marrow infiltration
- Lack of sufficient autologous hematopoietic stem cells for transplantation.
- Prior treatment with murine antibodies
- Known hypersensibility to murine antibodies or proteins
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Adult patient unable to give informed consent because of intellectual impairment.
- Pregnant or lactating women.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00689169
Start Date
August 1 2007
End Date
January 1 2014
Last Update
March 7 2018
Active Locations (1)
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1
service d'onco hématologie adultes, hôpital Saint Louis
Paris, France, 75010