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Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
Conditions
Non-Hodgkin's Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
Zevalin, Autologous one Marrow Transplant, Non-Hodgkin's Lymphoma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
Type: Drug
Overall Status
Not yet recruiting
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 chemotherapy and autologous peripheral stem cell transplantation in patients with relapsed, refractory, or transformed Non-Hodgkin's lymphoma.
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 combined with high-dose chemotherapy may increase response and survival rates in a safe and reliable manner.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Age >=18 to <=70 years
2. 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
3. Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg.
Exclusion Criteria:
1. Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN)
2. Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN)
3. Cardiac ejection fraction <40%
4. Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60% predicted) or receiving continuous oxygen
5. A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
6. 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
7. Prior radiotherapy to >25% of the bone marrow or >20 Gy to critical organ (lung, liver, kidney, spinal cord).
8. CNS lymphoma
9. Ongoing infection
10. Prior treatment with radioimmunotherapy
1. Age >=18 to <=70 years
2. 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
3. Prior collection of at least 2.5x10^6 CD34-positive peripheral blood stem cells/kg.
Exclusion Criteria:
1. Abnormal renal function (Creatinine >2.5x upper limit of normal (ULN)
2. Abnormal hepatic function (Bilirubin >2xULN, ALT/AST >3x ULN)
3. Cardiac ejection fraction <40%
4. Severe defects in pulmonary function tests (DLCO<70% predicted, FEV1, FVC<60% predicted) or receiving continuous oxygen
5. A history of human anti-mouse antibodies (HAMA) or known type 1 hypersensitivity or anaphylactic proteins to any component of the Zevalin therapy.
6. 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
7. Prior radiotherapy to >25% of the bone marrow or >20 Gy to critical organ (lung, liver, kidney, spinal cord).
8. CNS lymphoma
9. Ongoing infection
10. Prior treatment with radioimmunotherapy
Location
McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, Canada
Status: Not yet recruiting
Contact: Ahmed Galal, MD - 514-934-1934 - galala@muhchem.mcgill.ca
Start Date
March 2007
Sponsors
McGill University
Source
McGill University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page