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Phase 4 N=111 Randomized Treatment

Treatment of Peripheral T-cell Lymphoma

Peripheral T-cell Lymphoma

Enrolled (actual)
111
Serious AEs
42.7%
Results posted
Oct 2016
Primary outcome: Primary: Progression-free Survival — 35; 27 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
GDPT regimen (Drug); CHOP regimen (Drug)
Age
Pediatric, Adult, Older Adult · 14+ yrs
Sex
All
Sponsor
Mingzhi Zhang
Primary completion
Apr 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival
35; 27
SECONDARY
Response Rate
SECONDARY
Overall Survival
SECONDARY
Median Survival Time

Summary

The purpose of this study is to evaluate the efficacy and safety of GDPT regiment (gemcitabine,cisplatin,Prednisone ,Thalidomide ) for patients with Peripheral T-cell lymphoma.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01664975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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