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Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma


Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be
treated successfully with the conventional chemotherapy of CHOP.The investigators did this
trial to evaluate the efficacy and tolerability of the combination chemotherapy of DICE in
the patients with NK/T cell lymphoma.


Inclusion Criteria:



- Age range 18-75 years old

- Histological confirmed NK/T cell lymphoma

- ECOG performance status less than 2

- Life expectancy of more than 3 months

- None of major drugs in the trial (IFO,VP16,DDP) has been previously used

- Normal laboratory values: hemoglobin > 80 g/dl, neutrophil > 2×109/L, platelet >
100×109/L, serum creatine < 1.5×upper limitation of normal (ULN), serum bilirubin <
1.5×ULN, ALT and AST < 2.5×ULN

Exclusion Criteria:

- Pregnant or lactating women

- Serious uncontrolled diseases and intercurrent infection

- The evidence of CNS metastasis

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

every two cycles

Safety Issue:

No

Principal Investigator

Ye Guo, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

DICE-NK/T

NCT ID:

NCT00568607

Start Date:

March 2007

Completion Date:

December 2010

Related Keywords:

  • Lymphoma
  • NK/T cell lymphoma
  • Response Rate
  • TTP
  • OS
  • Toxicities
  • Lymphoma
  • Lymphoma, T-Cell

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