Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Leukemia
PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA
NCT00019227CI-TRIAL-00010897completedPhase 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)
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pentetic acid calcium | Drug | — | UNRESOLVED |
| yttrium Y 90 daclizumab | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage
* Tac expression of malignant cells confirmed by one of the following:
* At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining
* Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL)
* Measurable disease required
* More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease
* All stages of Tac-expressing adult T-cell leukemia are eligible
* Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat
* Smoldering ATL, defined as:
* Lymphocyte count less than 4,000/mm\^3
* Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood
* No hypercalcemia
* Lactate dehydrogenase no greater than 1.5 times normal
* No lymphadenopathy
* No involvement of extranodal organs except skin or lung
* No malignant pleural effusion or ascites
* No symptomatic CNS disease due to ATL
* Concurrent diagnosis of tropical spastic paraparesis allowed
* No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Not specified
Life expectancy:
* Greater than 2 months
Hematopoietic:
* Absolute granulocyte count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL (unless directly due to ATL)
* AST/ALT less than 2.5 times normal
Renal:
* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance greater than 35 mL/min
Cardiovascular:
* No clinical cardiac failure
Pulmonary:
* No symptomatic pulmonary dysfunction unless due to underlying malignancy
Other:
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 4 weeks since prior cytotoxic chemotherapy
Endocrine therapy
* Concurrent corticosteroids allowed
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.