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Trial Title:
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
Condition:
Non-Hodgkin's Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Conditions: Keywords:
Zevalin
Autologous one Marrow Transplant
Non-Hodgkin's Lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Yttrium 90 Ibritumomab Tiuxetan ( Zevalin )
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
McGill University Health Center, Royal Victoria Hospital
Address:
City:
Montreal
Zip:
H3A1A1
Country:
Canada
Contact:
Last name:
Ahmed Galal, MD
Phone:
514-934-1934
Phone ext:
31558
Email:
galala@muhchem.mcgill.ca
Investigator:
Last name:
Ahmed Galal, MD
Email:
Principal Investigator
Start date:
March 2007
Lead sponsor:
Agency:
McGill University
Agency class:
Other
Collaborator:
Agency:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency class:
Other
Source:
McGill University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00438581
