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A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma


Phase 1
12 Years
N/A
Not Enrolling
Both
Hodgkin's Lymphomas

Thank you

Trial Information

A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1401 Administered Weekly for 4 Weeks in Patients With CD30-positive Refractory/Relapsed Hodgkin's Lymphoma


Inclusion Criteria:



- Diagnosis of CD30-positive HL by immunohistochemistry or flow cytometry

- Must have failed or relapsed following second line chemotherapy or radiation or
failed/relapsed following autologous stem cell transplant

- Bi-measurable disease

- ECOG Performance Status of 0 - 2

- Meet all screening laboratory values

Exclusion Criteria:

- Previous treatment with any other anti-CD30 antibody

- History of allogeneic transplant

- Any tumor lesion greater than or equal to 10 cm in diameter

- Any active or chronic significant infection

- Underlying medical condition which will make the administration of MDX- 1401
hazardous

- Concomitant corticosteroids, chemotherapy, investigational agents, other anti-HL
biologics, or radiation therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Tolerability Profile

Outcome Time Frame:

Two years

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

MDX1401-01

NCT ID:

NCT00634452

Start Date:

February 2008

Completion Date:

January 2010

Related Keywords:

  • Hodgkin's Lymphomas
  • Hodgkin's
  • Cancer
  • bi-measurable disease
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
Scott and White Memorial Hospital and ClinicTemple, Texas  
West Virginia UniversityMorgantown, West Virginia  26506
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
ClinWorks Cancer Research CenterCharlotte, North Carolina  28207