Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma
Phase 1
Terminated
- Conditions
- Non-Hodgkins Lymphoma
- Registration Number
- NCT00054834
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The purpose of this trial is to determine the safety of 90Y-hLL2 at different dose levels in the treatment of Non-Hodgkin's lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Age Range: Male or Female at least 18 years of age
- Performance Status: Patients with a Karnofsky performance status > 60% (or equivalent, ECOG 0-2) and expected survival of at least 12 weeks.
- Hematopoietic: Hemoglobin > 10 g/dL; ANC > 1.5x10^9/L; Platelets > 100x10^9/L;
- Hepatic: Serum bilirubin < 2.0 mg/dL; AST and ALT < 2 x ULN w/o liver metastases or <5 x ULN w/liver metastases
- Renal: Creatinine < 2.0 mg/dL
- Cardiovascular: Patients with LVEF >/= 50% by MUGA or 2D-ECHO.
- Pulmonary: Patients with DFCO and FEV1 >/= 60% by required Pulmonary Function Tests.
- Other: Patients agreeing to use a medically effective method of contraception while enrolled in the study. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie 90Y-hLL2's targeting of CD20 in refractory Non-Hodgkin's lymphoma?
How does 90Y-hLL2 compare to standard-of-care therapies like rituximab in treating recurrent NHL?
Which biomarkers correlate with response to 90Y-hLL2 in CD20-positive B-cell lymphoma subtypes?
What are the key adverse events associated with 90Y-hLL2 and how are they managed in NHL patients?
Are there combination therapies involving 90Y-hLL2 and other agents like lenalidomide for NHL treatment?
Trial Locations
- Locations (2)
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fox Chase Cancer Center🇺🇸Philadelphia, Pennsylvania, United States