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Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly


Phase 3
61 Years
80 Years
Open (Enrolling)
Both
Peripheral T Cell Lymphoma, Unspecified, Angioimmunoblastic Lymphadenopathy, Extranodal NK/T-cell Lymphoma

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Trial Information

Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly


Inclusion Criteria:



- all risk groups of peripheral T cell lymphoma

- performance status ECOG 0-2

- written consent

- measurable disease

Exclusion Criteria:

- stage I N without bulky disease

- already initiated treatment

- serious accompanying disorder or impaired organ function

- bone marrow involvement >25%

- HIV positivity

- leukemic manifestation of lymphoma

- simultaneous participation in another trial

- platelets < 100 000/ mm, leukocytes < 2500 /mm

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Lorenz H Trümper, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Göttingen

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

DSHNHL 2006-1B / ACT-2

NCT ID:

NCT00725231

Start Date:

February 2008

Completion Date:

March 2014

Related Keywords:

  • Peripheral T Cell Lymphoma, Unspecified
  • Angioimmunoblastic Lymphadenopathy
  • Extranodal NK/T-cell Lymphoma
  • T cell lymphoma
  • Immunoblastic Lymphadenopathy
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphatic Diseases

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