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NCT01664975 · REGISTRY CONDITION SEARCH

Treatment of Peripheral T-cell Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE4
Status at capture
COMPLETED
Registry last update
2016-10-05

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival

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outcome · NOT POSTED

Response Rate

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outcome · NOT POSTED

Overall Survival

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outcome · NOT POSTED

Median Survival Time

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
70 Years
minimum Age
14 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
    intervention Names
    1. Drug: GDPT regimen
    label
    GDPT regimen
    type
    EXPERIMENTAL
  2. description
    CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen
    intervention Names
    1. Drug: CHOP regimen
    label
    CHOP regimen
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. GDPT regimen
    description
    GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
    name
    GDPT regimen
    type
    DRUG
  2. arm Group Labels
    1. CHOP regimen
    description
    CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.
    name
    CHOP regimen
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
100
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression-free Survival
    time Frame
    up to end of follow-up-phase (approximately 24 months)
secondary Outcomes
  1. description
    21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles
    measure
    Response Rate
    time Frame
    every 6 weeks,up to completion of treatment(approximately 18 weeks )
  2. measure
    Overall Survival
    time Frame
    up to the date of death (approximately 5 years)
  3. measure
    Median Survival Time
    time Frame
    24 months
Full study description
brief 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.
detailed Description
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.
Source references
references
  1. citation
    Sun Y, Li L, Li X, Zhang L, Wang X, Fu X, Sun Z, Zhang X, Li Z, Wu J, Yu H, Chang Y, Yan J, Wu X, Zhou Z, Nan F, Tian L, Zhang M. Outcomes of GDPT (gemcitabine, cisplatin, prednisone, thalidomide) versus CHOP in newly diagnosed peripheral T-cell lymphoma patients. Ther Adv Med Oncol. 2020 May 27;12:1758835920923829. doi: 10.1177/1758835920923829. eCollection 2020.
    pmid
    32550864
    type
    DERIVED
  2. citation
    Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. doi: 10.1111/bjh.14763. Epub 2017 Jun 9.
    pmid
    28597542
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT01664975
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string sha256
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    Preserved source evidence · Not medical advice