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A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hodgkin Lymphoma

Thank you

Trial Information

A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma


Inclusion Criteria:



- Treatment-naïve

- Histologically confirmed classical Hodgkin Lymphoma (HL)

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Bidimensional measurable disease

Exclusion Criteria:

- Nodular lymphocyte predominant Hodgkin lymphoma

- Cerebral/meningeal disease, including signs and symptoms of progressive multifocal
leukoencephalopathy (PML)

- Pulmonary diffusion capacity > 25% lower than normal predicted value

- Sensory or motor peripheral neuropathy

- Known human immunodeficiency virus (HIV) positive

- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
infection

Please note that there are additional exclusion criteria. The study center will determine
if you meet all of the criteria.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Modified progression free survival (mPFS) per independent review facility (IRF)

Outcome Time Frame:

Date of randomization to mPFS event, for approximately 3 to 5 years

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C25003

NCT ID:

NCT01712490

Start Date:

October 2012

Completion Date:

March 2020

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Hodgkin's Lymphoma
  • Antibody, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD-30
  • Immunotherapy
  • Lymphoma
  • Lymphoma, Classical
  • Hodgkin Disease
  • Lymphoma

Name

Location

Hackensack University Medical CenterHackensack, New Jersey  07601
Center for Cancer and Blood DisordersBethesda, Maryland  20817
West Virginia UniversityMorgantown, West Virginia  26506
Saint Francis HospitalGreenville, South Carolina  29601
Columbia Basin Hematology and OncologyKennewick, Washington  99336
Comprehensive Care Centers of NevadaLas Vegas, Nevada  89169