Status:
COMPLETED
Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
B-cell Chronic Lymphocytic Leukemia
Nodal Marginal Zone B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoc...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the feasibility, safety, and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched r...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed diagnosis of a lymphoid malignancy expressing the cluster of differentiation (CD)20 antigen and have failed at least one prior standard systemic therapy
- Patients must have evidence of persistent lymphoma by physical examination, radiographic studies, bone marrow evaluation, flow cytometry, or polymerase chain reaction (PCR)
- Creatinine \< 2.0
- Bilirubin \< 1.5 mg/dL
- Patients must have an expected survival of \> 60 days and must be free of major infection including human immunodeficiency virus (HIV)
- Patients must have an HLA-identical related or unrelated donor
- DONOR: Donor eligibility includes both HLA-matched relatives or HLA matched, unrelated volunteer donors; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and DRB1 according to FHCRC Standard Practice Guidelines and to the allele level at DQB1; unrelated donors should be identified using matching criteria that follows the FHCRC Standard Practice Guidelines limiting the study to eligible donors that are allele matched for HLA-A, B, C, DRB1, and DQB1 (Grade1), and accepting up to one allele mismatch as per Standard Practice Grade 2.1 for HLA-A, B, or C
- Donor must consent to granulocyte colony-stimulating factor (G-CSF) (filgrastim) administration and leukapheresis
- Donor must have adequate veins for leukapheresis or agree to placement of central venous catheter (femoral, subclavian)
Exclusion
- Systemic anti-lymphoma therapy given in the previous 30 days
- Patients who have experienced progressive disease within 3 months of prior Bexxar or Zevalin
- Inability to understand or give an informed consent
- Central nervous system lymphoma
- Pregnancy
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Southwest Oncology Group (SWOG)/Eastern Cooperative Oncology Group (ECOG) performance score \> 2
- Eligible for radioimmunotherapy-based autologous transplant trial
- Medical condition that would contraindicate allogeneic transplantation
- Evidence of Human Anti-Mouse Antibody (HAMA) for patients with prior exposure to therapeutic murine antibodies
- Eligible for other therapeutic options that will be more likely to have a better long-term disease-free survival with lower potential toxicity (e.g., non-transplant therapy, autologous transplants, etc.) than this study
- Other grave medical conditions considered to represent contraindications to bone marrow transplant (BMT) (e.g. unstable angina, pulmonary dysfunction \[diffusing capacity of the lung for carbon monoxide (DLCO) \< 30%, total lung capacity (TLC) \< 30%, continuous supplemental oxygen\], acquired immune deficiency syndrome \[AIDS\], etc.)
- DONOR: Identical twin
- DONOR: Age less than 12 years
- DONOR: Pregnancy
- DONOR: Infection with HIV
- DONOR: Inability to achieve adequate venous access
- DONOR: Known allergy to G-CSF
- DONOR: Current serious systemic illness or infection
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00119392
Start Date
June 1 2004
End Date
April 23 2016
Last Update
June 29 2018
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109