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Study of 90Y-hLL2 to Treat Non-Hodgkin's Lymphoma

A Phase I Clinical Trial of Radiolabeled Immunotherapy With Humanized LL2 in Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00054834
Enrollment
27
Registered
2003-02-13
Start date
2003-03-31
Completion date
Unknown
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkins Lymphoma

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.

Interventions

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Disease Characteristics: * Patients with a documented histologic or cytologic diagnosis of B-cell NHL. * Patients who have failed at least one regimen of chemotherapy and are not eligible for any alternate therapies of higher therapeutic priority. * Patients with at least one measurable tumor site \> 1.5 cm in at least one dimension. Prior/Concurrent Therapy: * Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority. * Biologic Therapy: Patients who have received human or humanized monoclonal antibodies will be eligible provided pre-study evaluations demonstrate no significant reactivity with hLL2 IgG (i.e., HAHA). * Radiotherapy: No prior radiation therapy to \>25% of the bone marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 2,000 cGy for the lungs and kidneys). Patients who have had whole pelvic irradiation are not eligible. Patient Characteristics/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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026