Status:
COMPLETED
Safety Study of NHL With 90Y-hLL2 IgG
Lead Sponsor:
Gilead Sciences
Conditions:
NHL
B-cell NHL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This will be an open label, multiple center, non-randomized, dose-escalation Phase I/II trial, designed to evaluate the safety and effectiveness of a repeated, outpatient regimen utilizing IMMU-hLL2 i...
Detailed Description
90Y-labeled hLL2 will be administered according to a schedule based upon whether or not a patient had prior high-dose chemotherapy with a marrow or stem cell transplant. Patients with both indolent an...
Eligibility Criteria
Inclusion
- All patients must have a histologic or cytological diagnosis of B-cell lymphoma, and have failed at least one regimen of standard chemotherapy. All histologic grades of non-Hodgkin's lymphoma (NHL) will be eligible for these studies.
- Patients must be \> 18 years of age
- Measurable disease by CT, with at least one lesion \> 1.5 cm in one or both dimensions
- less than 25% bone marrow involvement as determined by bone marrow biopsy
- Patient must have greater than 15% cellularity of the bone marrow.
- Patients must be at least 4 weeks beyond any major surgery.
- Patients must be at least 4 weeks beyond any radiation therapy to the index lesion and must have recovered from radiation induced toxicity.
- Patients must be at least 4 weeks beyond prior chemotherapy and/or immunotherapy, or 2-weeks after corticosteroids, and their blood counts must be within the eligibility criteria. Corticosteroids may, however, be given concomitantly if used to treat adrenal insufficiency
- Patients must have a performance status of 70 or greater on the Karnofsky scale equivalent to ECOG 0-1 (See Appendix A) and a minimal life expectancy of 6 months.
- Patients must be able to give cognizant informed consent.
Exclusion
- Patients with a significant concurrent medical complication including severe anorexia, nausea or vomiting that in the judgement of the Investigator could affect the patient's ability to tolerate or complete this study.
- Patients with metastasis to the brain.
- Patients with extensive irradiation to more than 25% of their red marrow will be excluded, except those who had total body irradiation in the context of bone marrow or stem cell transplantation regimen with subsequent engraftment of a functional marrow (i.e., resulting in normal peripheral blood counts). Subjects who have received external radiation to specific organs or areas at the maximum tolerated level are also excluded.
- Women who test positive for pregnancy.
- Patients with splenomegaly.
- Patients with \> 4 treatment regimens prior to this protocol, including chemotherapy, radiotherapy and/or other immunotherapy.
- Patients with prior radioimmunotherapy treatments (unless for retreatment under this protocol).
- Patients receiving rituximab within 3 months, unless progressing after treatment.
- Patients with \<50% LVEF by required MUGA or 2-D ECHO.
- Patients with \<60% of predicted value by required pulmonary function tests.
- Patients who have active Hepatitis B or C or are known HIV positive.
- Patients with another primary malignancy (except basal/squamous cell carcinoma of the skin or carcinoma in-situ of the cervix.
- Patients with other serious medical, surgical, or psychiatric history, unless currently stable and well controlled, without significant increase in treatment medications for at least 30 days preceding study entry.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00421395
Start Date
August 1 2002
End Date
October 1 2007
Last Update
August 16 2021
Active Locations (5)
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1
Research Unit 463 INSERM
Nantes, Cedex, France, 44035
2
Service des Maladies du Sang
Lille, France, 59037
3
University Hospital Dresden
Dresden, Germany, 01307
4
Klinikum der Georg-August-Universitat Gottingen
Göttingen, Germany, 37075