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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02918747
• Other study ID #: HNCH-NKT-2016
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Hunan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

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.
• Gemcitabine
800mg/m2, ivd on day 1 and 5 of each 21 day cycle. Number of Cycles: four.
• Oxaliplatin
85 mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: four
• Dexamethasone
15 mg, Ivd on day 1 to day 5 of each 21 day cycle. Number of Cycles: four.
• Cyclophosphamide
750 mg/m2,ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
• Doxorubicin
50mg/m 2,ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
• Vincristine
1.4 mg/m 2(=2mg),ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
• 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.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Epstein-Barr virus (EBV) DNA copies		every 3 weeks,up to completion of treatment (approximately 6 months)
Primary	Objective response rate(complete remission rate + partial remission rate)	The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article: Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.	every 6 weeks,up to completion of treatment (approximately 6 months)
Primary	progression free survival	time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first	up to end of follow-up-phase (approximately 3 years)
Primary	overall survival	overall survival (OS): time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first	up to end of follow-up-phase (approximately 3 years)
Secondary	Incidence of Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events v3.0	including hematological safety and non-hematological safety. All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)	every 3 weeks,up to completion of treatment (approximately 6 months)