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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huiqiang Huang
• Collaborator: Sun Yat-sen University
• Treatments: Asparaginase; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine; Methotrexate; Oxaliplatin; Pegaspargase; Thalidomide

Criteria

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:

-