Back to resultsPEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma
Primary Purpose
Treatment Refusal
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
etoposide
Pegaspargase
involved-field radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Refusal focused on measuring extranodal natural killer/T-cell lymphoma, nasal type, chemotherapy, radiotherapy
Eligibility Criteria
Inclusion Criteria:
- pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification;
- age≥18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- at least one measurable lesion;
- adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l),
- adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
- adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
- normal coagulation function and electrocardiogram results.
- Prior chemotherapy and radiotherapy should have been completed >4 weeks 10.earlier,willingness to provide written informed consent.
Exclusion Criteria:
-
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEG group
Arm Description
Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500U/m2 Pegaspargase at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
overall survival
complete remission rate
Full Information
NCT ID
NCT02705508
First Posted
March 7, 2016
Last Updated
June 15, 2023
Sponsor
Sun Yat-sen University
Collaborators
China Food and Drug Administration
1. Study Identification
Unique Protocol Identification Number
NCT02705508
Brief Title
PEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma
Official Title
Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
China Food and Drug Administration
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population.
Detailed Description
Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 PEG-ASP at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after achieving CR for advanced stage and refractory/relapsed patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Refusal
Keywords
extranodal natural killer/T-cell lymphoma, nasal type, chemotherapy, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PEG group
Arm Type
Experimental
Arm Description
Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500U/m2 Pegaspargase at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
1000mg/m2, ivd on day 1 and 8 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
Etoposide phosphate
Intervention Description
100mg/m2，4h-intravenous infusion on day1-3 of each 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Other Intervention Name(s)
Oncaspar
Intervention Description
2500U/m2 im on day 1 of each 21 day cycle.
Intervention Type
Radiation
Intervention Name(s)
involved-field radiotherapy
Other Intervention Name(s)
IFRT
Intervention Description
Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy.
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
up to end of follow-up-phase (approximately 3 years)
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
up to end of follow-up-phase (approximately 3 years)
Title
complete remission rate
Time Frame
every 3 weeks,up to completion of chemotherapy(approximately 3months)
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Description
including hematological safety and non-hematological safety
Time Frame
up to end of follow-up-phase (approximately 3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification;
age≥18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
at least one measurable lesion;
adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l),
adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
normal coagulation function and electrocardiogram results.
Prior chemotherapy and radiotherapy should have been completed >4 weeks 10.earlier,willingness to provide written informed consent.
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hua wang, MD.
Phone
0086-02087342462
Email
wanghua@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
hua wang, MD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hua wang, MD.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Please Select
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hua wang, MD.
Phone
0086-02087342462
Email
wanghua@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
PEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma
We'll reach out to this number within 24 hrs