Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Secondary objectives include:
* to characterize progression-free survival
* to characterize time to progression
* to determine response duration
* to characterize the effect of study drug on health-related quality of life
* to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population
* to characterize the immunogenicity response of MDX-060
* to characterize the safety of MDX-060, and
* to characterize the pharmacokinetic profile of MDX-060
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
