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Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma


N/A
18 Years
80 Years
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma

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Trial Information

Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma


Inclusion Criteria:



- Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as
defined in the WHO classification

- Completion of at least 4 cycles of a rituximab-containing, anthracycline-based
combination chemotherapy

- Negative post-chemotherapy (or interim) PET scan

- Absolute neutrophil count greater than 1500 and platelet count greater than 40,000

- Negative pregnancy test in women of child-bearing potential

For patients with HIV/AIDS, the following must be true:

- The patient is compliant on combination anti-retroviral therapy (CART)

- The patient has CD4 count ≥ 200 at time of diagnosis

Exclusion Criteria:

- Any contraindications to irradiation

- Primary CNS lymphoma

- HIV/AIDS

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Actuarial Freedom from Local Failure

Outcome Time Frame:

5 year

Safety Issue:

No

Principal Investigator

Christopher Kelsey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center, Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

Pro00025164

NCT ID:

NCT01186978

Start Date:

October 2010

Completion Date:

February 2016

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Durham Regional HospitalDurham, North Carolina  27704-2763
Duke University Medical CenterDurham, North Carolina  27710
Duke Raleigh HospitalRaleigh, North Carolina  27609