Clinical trial · Interventional
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
NCT00001249CI-TRIAL-00001223completedPhase 1ClinicalTrials.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 study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium-90 radiolabeled anti-Tac antibody | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL). Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required. All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL. All forms of ATL eligible, including the "smoldering" type as well as aggressive disease. No symptomatic CNS disease other than tropical spastic paraparesis. Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate). PRIOR/CONCURRENT THERAPY: Biologic Therapy: Not specified. Chemotherapy: CTCL must have failed initial chemotherapy. ATL may or may not have had prior chemotherapy. At least 4 weeks since prior cytotoxic chemotherapy. Endocrine Therapy: Not specified. Radiotherapy: At least 4 weeks since prior radiotherapy. Surgery: Not specified. PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: Not specified. Life expectancy: Greater than 1 month. Hematopoietic: WBC at least 3,000, Platelets at least 75,000. Hepatic: Not specified. Renal: Not specified. Other: No pregnant women. Negative pregnancy test required of fertile women.
References
Publications (2)
- BACKGROUNDWaldmann TA, Goldman CK, Bongiovanni KF, Sharrow SO, Davey MP, Cease KB, Greenberg SJ, Longo DL. Therapy of patients with human T-cell lymphotrophic virus I-induced adult T-cell leukemia with anti-Tac, a monoclonal antibody to the receptor for interleukin-2. Blood. 1988 Nov;72(5):1805-16. PMID 2846094
- BACKGROUNDKozak RW, Raubitschek A, Mirzadeh S, Brechbiel MW, Junghans RP, Gansow OA, Waldmann TA. Nature of the bifunctional chelating agent used for radioimmunotherapy with yttrium-90 monoclonal antibodies: critical factors in determining in vivo survival and organ toxicity. Cancer Res. 1989 May 15;49(10):2639-44. PMID 2785435