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Phase 4 Completed N=111 Randomized Treatment

Treatment of Peripheral T-cell Lymphoma

Source: ClinicalTrials.gov NCT01664975 ↗
Enrolled (actual)
111
Serious AEs
42.7%
Results posted
Oct 2016
Primary outcomePrimary: Progression-free Survival — 35; 27 participants
◆ Published Evidence
Established
35citations · ~4 / year
The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers.
British journal of haematology · 2017 · Open access · Likely link

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.

Linked Publications (2)

  • The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers.
    British journal of haematology · 2017 · 35 citations · Open access · Likely link
  • Outcomes of GDPT (gemcitabine, cisplatin, prednisone, thalidomide) <i>versus</i> CHOP in newly diagnosed peripheral T-cell lymphoma patients.
    Therapeutic advances in medical oncology · 2020 · 19 citations · Open access · Likely link

Outcome Measures

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

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) and the linked publication. 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. Informational only — not medical advice.

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