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Complete title: A phase II trial of high-dose 90Y-Ibritumomab tiuxetan (anti-CD20) followed by fludarabine and low-dose total body irradiation and HLA-matched allogeneic hematopoietic transplantation for patients with relapsed or refractory aggressive B-cell lymphoma
|Research Study Number||2398.00|
|Principal Investigator||Ajay Gopal, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients must have a histologically confirmed diagnosis of aggressive B-cell lymphoma (diffuse large B-cell lymphoma [DLBCL], Burkitt lymphoma [BL], etc.) expressing the CD20 antigen and have failed at least one prior standard systemic therapy
- Patients must have relapsed after high-dose therapy and autologous transplantation or be ineligible for high-dose therapy and autologous transplantation; patients that have failed autologous transplantation are those with persistent disease > 30 days after transplant; those ineligible for autologous transplant include those with chemoresistant disease (i.e., patients who have not achieved a partial response or better with their most recent chemotherapy regimen), are expected to have a poor outcome from autologous transplant (e.g., DLBCL relapsing within one year of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone [R-CHOP]-like chemotherapy, double hit lymphoma, v-myc myelocytomatosis viral oncogene homolog (avian) positive [MYC+] lymphoma, persistent positron emission tomography [PET] positivity after chemotherapy), are unable to collect sufficient or tumor-free autologous stem cells per Seattle Cancer Care Alliance (SCCA) standard practice, are unable to tolerate the high-dose autologous conditioning regimens, or who refuse a high-dose autologous transplant regimen
- Creatinine (Cr) < 2.0
- Bilirubin < 1.5 mg/dL with the exception of patients thought to have Gilbert's syndrome, who may have a total bilirubin above 1.5 mg/dL
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN)
- Patients must have an expected survival without treatment of > 60 days and must be free of major infection including human immunodeficiency virus (HIV)
- Patients must have an HLA-identical related or HLA-matched unrelated donor
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Inability to understand or give an informed consent
- Active central nervous system lymphoma
- 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
- High-dose chemotherapy or external beam radiation therapy to lung, liver, or kidneys > 20 Gy within the previous 100 days prior to therapeutic 90Y-ibritumomab tiuxetan dose
- Medical condition that would contraindicate allogeneic transplantation as per standard practice guidelines (e.g., impaired cardiopulmonary function, hepatitis, etc)
- Altered biodistribution (determined following trace-labeled 111In-ibritumomab tiuxetan dose)
Other exclusion criteria may apply.
Lymphoma, Burkitt's; Hematologic Malignancies; Lymphoma, Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Non-Hodgkin (NHL); Immunoproliferative Disorders; Lymphoma, B-Cell
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