Status:
COMPLETED
Retreatment of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti B1 Antibody
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This multicenter study will determine the response rate, the complete response rate, duration of response, time to progression, time-to-treatment failure, safety, and survival following treatment with...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed initial diagnosis of non-Hodgkin's B-cell lymphoma
- Patients must have previously responded with a duration of response of at least 3 months to Iodine-131 Anti-B1 Antibody therapy
- Patients must have evidence that their tumor tissue had CD20 expression
- Patients must have performance status of at least 60% on the Karnofsky scale and an anticipated survival of at least 3 months
- Patients must have absolute granulocyte count (ANC) greater than 1,500 cells/mm3 and platelet count greater than 100,000 cells/mm3 within 14 days of study entry without support of hematopoietic cytokines or transfusion of blood products
- Patients must have adequate renal (serum creatine less than 1.5 x upper limit of normal) and hepatic function (total bilirubin less than 1.5 x upper limit of normal and hepatic transaminases, AST and ALT, less than 5 x upper limit of normal) within 14 days of study entry
- Patients must have bi-dimensionally measurable disease with a least one lesion greater than or equal to 2 cm x 2 cm by CT scan
- Patients must be at least 18 years of age
- Patients must give written informed consent and sign an Institutional Review Board/Ethics Committee- approved informed consent form prior to study entry
Exclusion
- Patients with more than 25% bone marrow involvement
- Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or who exhibit persistent clinical evidence of toxicity. The use of systemic steroids much be discontinued at least 1 week prior to study entry.
- Patients with active obstructive hydronephoresis
- Patients with evidence of active infection requiring IV antibiotics at time of study entry
- Patients with New York Heart Association class III or IV heart disease or other serious illness that would preclude evaluation
- Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years
- Patients with known HIV infection
- Patients with known brain or leptomeningeal metasteses
- Patients who are pregnant or nursing
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00938041
Start Date
April 1 1998
End Date
June 1 2013
Last Update
January 9 2017
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