Peripheral T-cell Lymphoma
Conditions
Keywords
Peripheral T-cell lymphoma;chemotherapy;, RR;PFS;OS
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.
Interventions
DRUGGDPT regimen
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.
DRUGCHOP regimen
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.
Sponsors
Zhengzhou University
Mingzhi Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival | up to end of follow-up-phase (approximately 24 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | every 6 weeks,up to completion of treatment(approximately 18 weeks ) | 21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles |
| Overall Survival | up to the date of death (approximately 5 years) | — |
| Median Survival Time | 24 months | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GDPT Regimen GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen
GDPT regimen: 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. | 52 |
| CHOP Regimen CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen
CHOP regimen: 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. | 51 |
| Total | 103 |
Baseline characteristics
| Characteristic | CHOP Regimen | GDPT Regimen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 4 Participants | 8 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 43 Participants | 89 Participants |
| Age, Continuous | 51 years | 55 years | 55 years |
| Region of Enrollment China | 51 participants | 52 participants | 103 participants |
| Sex: Female, Male Female | 31 Participants | 16 Participants | 47 Participants |
| Sex: Female, Male Male | 20 Participants | 36 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 52 | 19 / 51 |
| serious Total, serious adverse events | 23 / 52 | 21 / 51 |
Outcome results
Primary
Progression-free Survival
Time frame: up to end of follow-up-phase (approximately 24 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GDPT Regimen | Progression-free Survival | 35 participants |
| CHOP Regimen | Progression-free Survival | 27 participants |
Secondary
Median Survival Time
Time frame: 24 months
Secondary
Overall Survival
Time frame: up to the date of death (approximately 5 years)
Secondary
Response Rate
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles
Time frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )