NCT02918747

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

P-Gemoxd Regimen Followed by Radiotherapy Versus P-CHOP Regimen Followed by Radiotherapy in ENKTL With Early Stage: a Randomized, Multicenter, Open-label, Phase 2 Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment PA-Gemoxd dosages were as follows: days 1 and 5, 30-min intravenous infusion of 800 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2000 U/m2 PEG-ASP at four different sites; d1-5, intravenous infusion of 15mg dexamethasone. The regimen was repeated every 3 weeks for four cycles 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2016-09-29
• Last updated: 2020-01-28

Locations

1 site across 1 country: China