Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas
NCT00006009CI-TRIAL-00010302completedPhase 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)
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 trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.
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 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| visilizumab | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed CD3+ T-cell lymphoma for which no standard curative therapy exists
* Peripheral T-cell lymphoma
* Recurrent and/or progressive disease after at least 1 prior therapy
* Mycosis fungoides
* Stage IB/IIA
* Recurrent and/or progressive disease after at least 2 prior therapies
* Stage IIB-IVB
* Recurrent and/or progressive disease after at least 1 prior therapy
* All other T-cell lymphomas
* Recurrent and/or progressive disease after at least 1 prior therapy
* Evaluable disease
* Any nodal site or mass lesion at least 1.5 cm in longest axis on physical exam or CT scan
* Skin lesions at least 1 cm in longest axis for cutaneous lymphoma
* High numbers of circulating T-cells allowed
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
* Karnofsky 50-100%
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 2,000/mm\^3\*
* Absolute neutrophil count at least 1,000/mm\^3\*
* Platelet count at least 75,000/mm\^3\* NOTE: \* Unless due to lymphoma
Hepatic:
* Bilirubin no greater than 2.0 times normal\*
* AST/ALT no greater than 2.5 times upper limit of normal\*
* Hepatitis B and C negative NOTE: \* Unless due to lymphoma
Renal:
* Not specified
Cardiovascular:
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other:
* No other uncontrolled illness
* No ongoing or active infection
* No other active malignancies except basal cell skin cancer or carcinoma in situ of the cervix
* HIV-1 negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
Biologic therapy:
* At least 60 days since prior humanized or chimeric antibody therapy
Chemotherapy:
* At least 3 weeks since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 3 weeks since prior radiotherapy
Surgery:
* Not specified
Other:
* At least 30 days since prior investigational drugs or therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.