Clinical trial · Interventional
Treatment of Non-Hodgkin's Lymphoma With 90Y-hLL2 IgG
Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG
NCT00061425CI-TRIAL-00053410completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiolabeled epratuzumab | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion: * Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.) * Measureable via CT, with at least one lesion \> or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.) * Radiological studies (ie - CT) must be performed within 4 weeks prior to study start. * Acceptable tumor burden that will allow adequate follow-up and evaluation. * Less that 25% bone marrow involvement, determined by bone marrow biopsy. * Must observe the following washout periods: At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity. At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria. * Must have Karnofsky score \>70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months. * Serum creatinine \< or = 1.5mg/dl or creatinine clearance \> or = 50ml/min. * Serum bilirubin \< or = 2mg/dl. * Hemoglobin \> or = 10 g/dl; WBC \> or = 3000/mm3; granulocyte count \> or = 150/mm3; platelet count \> or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study. * Immunomedics ELISA assay of HahLL2 \< 100ng/ml for those with prior history of monoclonal antibody infusions. * Cognizant informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.