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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02085655
Other study ID # NKT-SYSUCC-2013
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 25, 2013
Est. completion date December 31, 2022

Study information

Verified date March 2021
Source Sun Yat-sen University
Contact HuiQiang Huang
Phone 86-020-87343350
Email huanghq@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 long-acting aspargase (pegylated aspargase, PEG-ASP) combined with gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.


Description:

Eligibility criteria The eligibility criteria were 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), 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), 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 earlier, willingness to provide written informed consent. Stage was defined according to the Ann Arbor system. The Sun Yat-Sen University Cancer Centre Research Ethics Board approved this study before subjects were enrolled. Treatment PA-Gemox dosages were as follows: days 1 and 8, 30-min intravenous infusion of 1000 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 130 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at two different sites. The regimen was repeated every 3 weeks for a maximum of six cycles. 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. 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 they achieved CR.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification; 2. age=18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. at least one measurable lesion; 5. adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), 6. 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), 7. adequate renal function (serum creatinine = 1.5 mg/dl, creatinine clearance = 50 ml/min); 8. normal coagulation function and electrocardiogram results. 9. Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier, 10. willingness to provide written informed consent. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
pegaspargase
pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Gemcitabine
1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Oxaliplatin
100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Methotrexate
3000m g/m2 civ 6-hour on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Dexamethasone
40mg ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Thalidomide
100-200mg, PO, after chemotherapy

Locations

Country Name City State
China Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Huiqiang Huang Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Efficacy Outcome Measure Up to 36 months
Primary Efficacy Outcome Measure Study group increase 15% 2-year PFS up to 24 months
Secondary Safety/Adverse Event Outcome Measure Number of Participants with Serious and Non-Serious Adverse Events Up to 36 months
See also
  Status Clinical Trial Phase
Recruiting NCT05254899 - Anti-PD-1 Antibody and P-GEMOX Chemotherapy Combined With Radiotherapy in High-risk Early-Stage ENKTL Phase 2
Recruiting NCT05149170 - Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL Phase 2
Completed NCT01238159 - Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma Phase 2