Study Combining Zevalin With High-Dose Chemotherapy Prior to Autologous StemCell Transplant in Patients With Relapsed, Refractory, or Transformed Non-Hodgkin's Lymphoma
NCT ID: NCT00438581
Last Updated: 2007-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
Yes
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
McGill University
OTHER
Principal Investigators
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Ahmed Galal, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Center, Royal Victoria Hospital
Locations
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McGill University Health Center, Royal Victoria Hospital
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Ahmed Galal, MD
Role: primary
Other Identifiers
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BMA-05-017-ZEV
Identifier Type: -
Identifier Source: org_study_id