PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma

Overview

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.

Full Title of Study: “PA-Gemox Regimen Followed by Thalidomide Versus AspaMetDex Regimen in NKTCL Patients:a Randomized, Open-label, Phase 3 Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • Drug: pegaspargase
    • pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
  • Drug: Gemcitabine
    • 1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
  • Drug: Oxaliplatin
    • 100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops
  • 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.
  • Drug: Thalidomide
    • 100-200mg, PO, after chemotherapy

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy Outcome Measure
    • Time Frame: up to 24 months
    • Study group increase 15% 2-year PFS

Secondary Measures

  • Safety/Adverse Event Outcome Measure
    • Time Frame: Up to 36 months
    • Number of Participants with Serious and Non-Serious Adverse Events

Participating in This Clinical Trial

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:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Huiqiang Huang
  • Collaborator
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Huiqiang Huang, Professor – Sun Yat-sen University
  • Overall Official(s)
    • HuiQiang Huang, Study Chair, Sun Yat-sen University
  • Overall Contact(s)
    • HuiQiang Huang, 86-020-87343350, huanghq@sysucc.org.cn

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