Treatment of Peripheral T-cell Lymphoma

• Sponsor: Mingzhi Zhang (Other)
• Overall Status: Completed
• CT.gov ID: NCT01664975
• Collaborator: Zhengzhou University (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 56
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral T-cell Lymphoma	Drug: GDPT regimen; Drug: CHOP regimen	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Multi-center Clinical Trial on Treatment of Peripheral T-cell Lymphoma With DGPT Regiment (Gemcitabine,Cisplatin,Prednisone ,Thalidomide )
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GDPT regimen GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen	Drug: 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.
Experimental: CHOP regimen CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Progression-free Survival [up to end of follow-up-phase (approximately 24 months)]

Secondary Outcome Measures

1. 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

2. Overall Survival [up to the date of death (approximately 5 years)]

3. Median Survival Time [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052

Sponsors and Collaborators

• Mingzhi Zhang
• Zhengzhou University

Investigators

• Principal Investigator: Mingzhi Zhang, Pro,Dr, The First Affiliated Hospital of Zhengzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
• ClinicalTrials.gov Identifier: NCT01664975
• Other Study ID Numbers: hnslblzlzx2011-3
• First Posted: Aug 14, 2012
• Last Update Posted: Oct 5, 2016
• Last Verified: Aug 1, 2016

• Keywords provided by Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University: Peripheral T-cell lymphoma;chemotherapy;; RR;PFS;OS
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

Participant Flow

Arm/Group Title	GDPT Regimen	CHOP Regimen
Arm/Group Description	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(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.
Period Title: Overall Study
STARTED	57	54
COMPLETED	52	51
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	GDPT Regimen	CHOP Regimen	Total
Arm/Group Description	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(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 of all reporting groups
Overall Participants	52	51	103
Age (Count of Participants)
<=18 years	1 1.9%	1 2%	2 1.9%
Between 18 and 65 years	43 82.7%	46 90.2%	89 86.4%
>=65 years	8 15.4%	4 7.8%	12 11.7%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55	51	55
Sex: Female, Male (Count of Participants)
Female	16 30.8%	31 60.8%	47 45.6%
Male	36 69.2%	20 39.2%	56 54.4%
Region of Enrollment (participants) [Number]
China	52 100%	51 100%	103 100%

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival
Time Frame	up to end of follow-up-phase (approximately 24 months)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	GDPT Regimen	CHOP Regimen
Arm/Group Description	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(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.
Measure Participants	52	51
Number [participants]	35 67.3%	27 52.9%

2. Secondary Outcome

Title	Response Rate
Description	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 )

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Overall Survival
Time Frame	up to the date of death (approximately 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Median Survival Time
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	GDPT Regimen		CHOP Regimen
Arm/Group Description	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(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.
All Cause Mortality
	GDPT Regimen		CHOP Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	GDPT Regimen		CHOP Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/52 (44.2%)		21/51 (41.2%)
Blood and lymphatic system disorders
Grade3/4 myelosuppression	23/52 (44.2%)		21/51 (41.2%)
Other (Not Including Serious) Adverse Events
	GDPT Regimen		CHOP Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/52 (40.4%)		19/51 (37.3%)
Gastrointestinal disorders
digestive tract toxicity	21/52 (40.4%)		19/51 (37.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.