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Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma: a Exploratory Phase II Study Study


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma

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Trial Information

Interim PET/CT Guided Cycle Numbers of R-CHOP in Patients With Diffuse Large B-cell Lymphoma: a Exploratory Phase II Study Study


R-CHOP is the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL).
However, the standard number of cycles is uncertain. Recently, interim PET/CT was found to
predict prognosis in DLBCL. The hypothesis of this study is to optimize the number of cycles
based on the interim results of PET/CT in order to avoid treatment exposure.


Inclusion Criteria:



- Previously untreated diffuse large B-cell lymphoma

- Age range 18-80 years old

- Eastern Cooperative Oncology Group performance status 0-2

- Life expectancy of more than 3 months

- Adequate organ function

Exclusion Criteria:

- Primary or secondary central nervous system involvement

- Previous serious cardiac disease

- History of other malignancies except cured basal cell carcinoma of skin and carcinoma
in-situ of uterine cervix

- Pregnant or lactating women

- Serious uncontrolled diseases and intercurrent infection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

3-year progression-free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

LMTG 13-01

NCT ID:

NCT01804127

Start Date:

February 2013

Completion Date:

December 2017

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • DLBCL
  • R-CHOP
  • PET/CT
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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