Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin s Lymphoma
Trial status: Open for Enrollment
Why is this study being done?
The treatment portion of this study consists of study drug administrations each week for four weeks in a row (a total of 4 treatment days). Patients will then return at intervals up to 12 weeks for blood samples and for evaluations to see if their disease responded and to monitor any adverse effects related to treatment. Some blood tests may then need to be repeated at least a few times and/or until any abnormal findings at earlier evaluations have resolved. Otherwise, patients will continue to be evaluated every 3 months for two years, then every 6 months up to 5 years or until the disease worsens. Participation in the study will end when NHL disease worsens.
Who is eligible to participate?
- Male or female, >18 years old
- Histological diagnosis of CD20+ B-cell NHL, with DLBCL or other aggressive lymphomas by WHO lymphoma criteria including mantle cell lymphoma and transformed follicular lymphoma.
- Failed at least one prior standard treatment regimen for NHL
- If DLBCL, either received, ineligible for or refused high-dose chemotherapy with stem cell transplant
- Measurable NHL disease by CT, with at least one lesion >1.5 cm in one dimension
- Adequate performance status (>70 Karnofsky scale, 0-1 ECOG)* with an estimated life expectancy of at least 6 months
- Laboratory parameters:
- Adequate hematology (Hemoglobin >/= 10 g/dL, ANC >/= 1.5 ´ 109/L, platelets >/=100 x 109/L) without ongoing transfusional support
- Adequate renal and liver function (creatinine and bilirubin = 1.5 x IULN; AST and ALT = 2.5 x IULN)
- Otherwise, 10 cm in its greatest diameter
- Bone marrow involvement ≥25%
- Prior external beam radiation therapy to >30% bone marrow.
- Pleural effusion with positive cytology for lymphoma
- Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive
- Known autoimmune disease or presence of autoimmune phenomena.
- Evidence of infection or requiring antibiotics within 7 days.
- Use of systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, <20 mg/day, or equivalent) which may continue if unchanged.
- Prior malignancies (other than non-melanoma skin cancer or carcinoma in situ of the cervix) unless disease free for 5 years.
- Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix.
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations