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A Randomized Controlled Multi-center Clinical Trial on Treatment of Peripheral T-cell Lymphoma With DGPT Regiment (Gemcitabine,Cisplatin,Prednisone ,Thalidomide )

Phase 4
14 Years
70 Years
Open (Enrolling)
Peripheral T-cell Lymphoma

Thank you

Trial Information

A Randomized Controlled Multi-center Clinical Trial on Treatment of Peripheral T-cell Lymphoma With DGPT Regiment (Gemcitabine,Cisplatin,Prednisone ,Thalidomide )

Patients with Peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot
be treated successfully with the conventional chemotherapy of CHOP. The investigators have
been proceeding this trial to evaluate the efficacy and safety of the combination
chemotherapy regiment GDPT regiment (gemcitabine,cisplatin,Prednisone ,Thalidomide

) in the patients with Peripheral T-cell lymphoma.

Inclusion Criteria:

Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
Histological confirmed Peripheral T cell lymphoma None of chemotherapy or radiotherapy has
been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl,
neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤
1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L,
serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable
lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test
of women at reproductive age must be negative Patients could be followed up None of other
relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy
except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion Criteria:

Disagreement on blood sample collection Patients allergic of any of drug in this regimen
or with metabolic disorder Pregnant or lactating women Serious medical illness likely to
interfere with participation Serious infection Primitive or secondary tumors of central
nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS
metastasis History of peripheral nervous disorder or dysphrenia patients participating in
other clinical trials patients taking other antitumor drugs patients estimated to be
unsuitable by investigato

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

up to end of follow-up-phase (approximately 24 months)

Safety Issue:


Principal Investigator

Mingzhi Zhang, Pro,Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First Affiliated Hospital of Zhengzhou University


China: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

December 2019

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Peripheral T-cell lymphoma;chemotherapy;
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral