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

NCT02918747 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

pegaspargase

P-Gemoxd Arm: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: four. P-CHOP Arm: 2000U/m2 im on day 2 of each 21 day cycle. Number of Cycles: four.

DRUG

Gemcitabine

800mg/m2, ivd on day 1 and 5 of each 21 day cycle. Number of Cycles: four.

DRUG

Oxaliplatin

85 mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: four

DRUG

Dexamethasone

15 mg, Ivd on day 1 to day 5 of each 21 day cycle. Number of Cycles: four.

DRUG

Cyclophosphamide

750 mg/m2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.

DRUG

Doxorubicin

50mg/m 2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.

DRUG

Vincristine

1.4 mg/m 2(≤2mg），ivdrip day 1 of each 21 day cycle. Number of Cycles: four.

DRUG

Prednisone

60 mg/m 2 /day orally on days1- 5 of each 21 day cycle. Number of Cycles: four.

RADIATION

IMRT

After chemotherapy, if the patients get CR, PR or SD, IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 -56grays (Gy) in 25-28 fractions.

Sponsors & Collaborators

  • Hunan Cancer Hospital

    lead OTHER

Principal Investigators

  • Hui Zhou, MD. · Hunan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918747 on ClinicalTrials.gov