Status:
UNKNOWN
Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
Lead Sponsor:
McGill University
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This aim of this study to evaluate the safety and efficacy of combining a single course of Yttrium 90 Ibritumomab Tiuxetan, a radiolabeled monoclonal antibody ( Zevalin ), with high-dose BEAM chemothe...
Detailed Description
Relapse rates after chemotherapy for relapsed, refractory or transformed Non-Hodgkin's lymphoma (NHL)remain very high. NHL is a radiosensitive tumor. We hypothesize that targeted radioimmunotherapy co...
Eligibility Criteria
Inclusion
- Age \>=18 to \<=70 years
- Relapsed or refractory Stage III or IV, grade 1,2, or 3 Follicular Lymphoma or transformed follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, or diffuse large B-Cell lymphoma as defined by the WHO and:
- Expressing the CD 20 antigen
- ECOG performance 0-2
- Written informed consent
- Prior collection of at least 2.5x10\^6 CD34-positive peripheral blood stem cells/kg.
Exclusion
- Abnormal renal function (Creatinine \>2.5x upper limit of normal (ULN)
- Abnormal hepatic function (Bilirubin \>2xULN, ALT/AST \>3x ULN)
- Cardiac ejection fraction \<40%
- Severe defects in pulmonary function tests (DLCO\<70% predicted, FEV1, FVC\<60% predicted) or receiving continuous oxygen
- A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
- Female patients who are pregnant or breast feeding, and adults of reproductive potential who are not employing an effective method of birth control during study treatment
- Prior radiotherapy to \>25% of the bone marrow or \>20 Gy to critical organ (lung, liver, kidney, spinal cord).
- CNS lymphoma
- Ongoing infection
- Prior treatment with radioimmunotherapy
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00438581
Start Date
March 1 2007
Last Update
February 27 2007
Active Locations (1)
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1
McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, Canada, H3A1A1