Clinical trial · Interventional
Epratuzumab in Treating Patients With Non-Hodgkin's Lymphoma
A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
NCT00042913CI-TRIAL-00013142unknownPhase 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 such as epratuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Randomized phase II trial to study the effectiveness of epratuzumab in treating patients who have non-Hodgkin's lymphoma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epratuzumab | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL)
* Relapsed or refractory after at least 1 regimen of standard therapy
* Prior therapy may include high-dose chemotherapy with autologous stem cell transplantation (ASCT) or immunotherapy
* Bidimensionally measurable disease
* At least 1 lesion at least 1.5 cm by CT scan
* No primary or secondary CNS lymphoma
* No HIV-related lymphoma
* No known or suspected transformed lymphoma (prior or concurrent)
* No bulky disease (i.e., any single mass greater than 10.0 cm)
* No pleural effusion with positive cytology for lymphoma
* Most recent pathology specimen available for collection
* No rapid disease progression or symptoms that indicate disease progression requiring rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe pain, or gastrointestinal or genitourinary obstruction)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 4 months
Hematopoietic
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 50,000/mm3 (transfusion independent)
* Hemoglobin at least 9.0 g/dL
Hepatic
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST and ALT less than 5 times ULN
* Hepatitis B surface antigen negative
* Hepatitis C negative
Renal
* Creatinine no greater than 2 times ULN
Other
* HIV negative
* No other primary malignancy within the past 3 years except squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer
* No other serious nonmalignant condition that would preclude study
* No serious infection
* No known human antichimeric antibodies or human antihuman antibody positivity
* No type 1 hypersensitivity or anaphylactic reactions to murine proteins
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 4 weeks since prior immunotherapy (unless clearly progressing)
* At least 12 weeks since prior ASCT
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (unless clearly progressing)
Endocrine therapy
* Not specified
Radiotherapy
* No prior radioimmunotherapy
Surgery
* At least 4 weeks since prior major surgery (unless patient has fully recovered)
Other
* At least 30 days since prior enrollment in clinical trials involving investigational devices or drugs
* No concurrent enrollment in other clinical trials involving investigational devices or drugs
* No concurrent investigational agents for disease other than NHLReferences
Publications (0)
Data not yet available
No reference posted for this study.