PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma
Study Details
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 long-acting aspargase (pegylated aspargase, PEG-ASP) combined with gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PEG-ASP+Gemox regimen group PEG-ASP 2000U/m2 im d1 Gemcitabine 800mg/m2 ivdrip 30min d1,8 Oxaliplatin 100mg/m2 ivdrip d1 Thalidomide 150-200mg po qn d8-21 |
Drug: pegaspargase
pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Names:
Drug: Gemcitabine
1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Names:
Drug: Oxaliplatin
100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Other Names:
Drug: Thalidomide
100-200mg, PO, after chemotherapy
|
Active Comparator: AspaMetDex regimen group Pegaspargase 2000U/m2 im, d1 methotrexate 3000m g/m2 civ 6-hour,d1, Calcium folinate 30mg iv q6h x6 Dexamethasone 40 mg ivdrip QD |
Drug: pegaspargase
pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Names:
Drug: Methotrexate
3000m g/m2 civ 6-hour on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Drug: Dexamethasone
40mg ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
|
Outcome Measures
Primary Outcome Measures
- Efficacy Outcome Measure [up to 24 months]
Study group increase 15% 2-year PFS
Secondary Outcome Measures
- Safety/Adverse Event Outcome Measure [Up to 36 months]
Number of Participants with Serious and Non-Serious Adverse Events
Other Outcome Measures
- Efficacy Outcome Measure [Up to 36 months]
Eligibility Criteria
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 earlier,
-
willingness to provide written informed consent.
Exclusion Criteria:
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Medical Oncology, Sun Yat-sen University Cancer Center, | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Huiqiang Huang
- Sun Yat-sen University
Investigators
- Study Chair: HuiQiang Huang, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NKT-SYSUCC-2013