Clinical trial · Interventional
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
NCT00284804CI-TRIAL-00019439completedPhase 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)
This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.
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 |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDX-060 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MDX-060 plus standard of care
- description
- MDX-060 in combination with gemcitabine
- interventionNames
- Drug: MDX-060
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Gemcitabine
- interventionNames
- Drug: MDX-060
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- Day 50/57
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Hodgkin's disease \[HD\] (excluding HIV-associated HD) * Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained * Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant * ECOG Performance Status of 0-2 * Patients must have bi-measurable disease * At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment * Life expectancy 12 weeks or greater * Screening laboratory values must be met * Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion. Exclusion Criteria: * Previous treatment with any anti-CD30 antibody * History of allogeneic transplant * Any tumor lesion 10cm or greater in diameter * Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible. * Any significant active or chronic infection * Apparent active or latent tuberculosis (TB) infection * Patients who are pregnant or nursing * Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events * Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.