Clinical trial · Interventional
MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma
NCT00059995CI-TRIAL-00010452completedPhase 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 such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed 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 |
|---|---|---|---|
| iratumumab | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed B-cell or T-cell lymphoma
* Hodgkin's lymphoma and anaplastic large cell lymphoma eligible
* No HIV-associated lymphoma
* CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry
* At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30
* Must meet one of the following criteria for relapsed/refractory disease:
* Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)
* Relapsed disease must be within the prior irradiated field
* Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option
* Disease progression must be within the prior irradiated field
* Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)
PATIENT CHARACTERISTICS:
Age
* Over 12
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* WBC at least 1,500/mm\^3\*
* Neutrophil count at least 1,000/mm\^3\*
* Platelet count at least 75,000/mm\^3\*
* Hemoglobin at least 8.0 g/dL\* NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Hepatic
* AST no greater than 2 times upper limit of normal (ULN)\*
* Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)\*
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Renal
* Creatinine no greater than 2 times ULN\* NOTE: \*Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 9 months after study participation
* HIV negative
* No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No active significant infection
* No apparent opportunistic infection, as indicated by any of the following:
* Purified protein derivative recently determined to be positive
* Infectious infiltrate by chest x-ray
* Recent changes in fever/chill patterns
* New, unexplained neurological symptoms
* No underlying medical condition that would preclude receiving study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No prior anti-CD30 antibody therapy
* No other concurrent biologic therapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* No concurrent systemic steroidal therapy (excluding physiologic doses)
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No other concurrent investigational agentsReferences
Publications (1)
- RESULTAnsell SM, Horwitz SM, Engert A, Khan KD, Lin T, Strair R, Keler T, Graziano R, Blanset D, Yellin M, Fischkoff S, Assad A, Borchmann P. Phase I/II study of an anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's lymphoma and anaplastic large-cell lymphoma. J Clin Oncol. 2007 Jul 1;25(19):2764-9. doi: 10.1200/JCO.2006.07.8972. Epub 2007 May 21. PMID 17515574