Overview

PEG-ASP+Gemoxd vs. PEG-ASP+CHOP as First-line Chemotherapy to Treatment NK/T-cell Lymphoma With Early Stage

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study to compare the efficacy of these two regimens. This prospective pilot study to compare the efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen for stage IE to IIE ENKTL.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hunan Cancer Hospital
Treatments:
Asparaginase
BB 1101
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Gemcitabine
Liposomal doxorubicin
Oxaliplatin
Pegaspargase
Prednisone
Vincristine
Criteria
Inclusion Criteria:

1. pathologically confirmed, previously untreated ENKTL with stage I/II (for stage I, the
patients should have one of the following risk factors: EBV-DNA > upper limit of
normal, lesions beyond nasal, fever, LDH elevation);

2. age range from 18 to 70 years;

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

4. at least one measurable lesion;

5. adequate haematologic function (haemoglobin > 8.0 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. Hepatitis B virus carriers should have normal HBV-DNA copies and should use antiviral
drugs. For patients with elevated HBV-DNA, should use antiviral drugs until the
HBV-DNA decrease to < the upper limit of normal.

8. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50
ml/min);

9. normal coagulation function and electrocardiogram results.

10. Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier,

11. willingness to provide written informed consent.

Exclusion Criteria:

1. mismatch the inclusion criteria

2. systematic central nervous system involvement, previous or concomitant malignancies
and any coexisting medical problems that could cause poor compliance with the study
protocol.

3. primary lesion not from the upper respiratory