Trial Outcomes & Findings for Treatment of Peripheral T-cell Lymphoma (NCT NCT01664975)

NCT ID: NCT01664975

Last Updated: 2016-10-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: up to end of follow-up-phase (approximately 24 months)
• Results posted on: 2016-10-05

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	57	54
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Peripheral T-cell Lymphoma

Baseline characteristics by cohort

Measure	GDPT Regimen n=52 Participants 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.	CHOP Regimen n=51 Participants 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.	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants	51 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	31 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	20 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment China	52 participants n=5 Participants	51 participants n=7 Participants	103 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Measure	GDPT Regimen n=52 Participants 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.	CHOP Regimen n=51 Participants 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.
Progression-free Survival	35 participants	27 participants

SECONDARY outcome

Timeframe: every 6 weeks,up to completion of treatment(approximately 18 weeks )

21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to the date of death (approximately 5 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

Adverse Events

GDPT Regimen

Serious events: 23 serious events

Other events: 21 other events

Deaths: 0 deaths

CHOP Regimen

Serious events: 21 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	GDPT Regimen n=52 participants at risk 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.	CHOP Regimen n=51 participants at risk 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.
Blood and lymphatic system disorders Grade3/4 myelosuppression	44.2% 23/52	41.2% 21/51

Other adverse events

Measure	GDPT Regimen n=52 participants at risk 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.	CHOP Regimen n=51 participants at risk 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.
Gastrointestinal disorders digestive tract toxicity	40.4% 21/52	37.3% 19/51

Additional Information

Mingzhi Zhang

Zhengzhou University

Phone: 0371-66295564

Email: mingzhi_zhang@126.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place