Back to results

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

Primary Purpose

Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

pegaspargase

Gemcitabine

Oxaliplatin

Dexamethasone

Cyclophosphamide

Doxorubicin

Vincristine

Prednisone

IMRT

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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);
age range from 18 to 70 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
at least one measurable lesion;
adequate haematologic function (haemoglobin > 8.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l),
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),
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.
adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
normal coagulation function and electrocardiogram results.
Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier,
willingness to provide written informed consent.

Exclusion Criteria:

mismatch the inclusion criteria
systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
primary lesion not from the upper respiratory

Sites / Locations

Hunan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

P-Gemoxd

P-CHOP

Arm Description

Pegaspargase+Gemcitabine+Oxaliplatin+Dexamethasone (PEG-ASP+Gemoxd): Patients received the P-Gemoxd chemotherapy regimen every 3 weeks. Pegaspargase 2000U/m2 im day 1, Gemcitabine 800mg/m2 ivdrip 30min day 1 and day 5, Oxaliplatin 85mg/m2 ivdrip day 1, Dexamethasone 15 mg ivdrip, QD, day 1 to day 5. IMRT：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.

Pegaspargase+Cyclophosphamide+Doxorubicin+Vincristine +Prednisone (P-CHOP)：Patients received the P-CHOP chemotherapy regimen every 3 weeks. Cyclophosphamide 750 mg/m2，ivdrip day 1； doxorubicin 50mg/m 2，ivdrip day 1；vincristine 1.4 mg/m 2(≤2mg），ivdrip day 1; Pegaspargase 2000U/m2 im，day 2 and prednisone (60 mg/m 2 /day) on days 1 to 5 orally. IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50-56 grays (Gy) in 25-28 fractions.

Outcomes

Primary Outcome Measures

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.

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

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02918747

First Posted

September 25, 2016

Last Updated

January 25, 2020

Sponsor

Hunan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02918747

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hunan Cancer Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P-Gemoxd

Arm Type

Experimental

Arm Description

Arm Title

P-CHOP

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

pegaspargase

Other Intervention Name(s)

Oncaspar

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vincristine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

IMRT

Other Intervention Name(s)

intensity-modulated radiation treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective response rate（complete remission rate + partial remission rate）

Description

Time Frame

every 6 weeks,up to completion of treatment (approximately 6 months)

Title

progression free survival

Description

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

Time Frame

up to end of follow-up-phase (approximately 3 years)

Title

overall survival

Description

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

Time Frame

up to end of follow-up-phase (approximately 3 years)

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events v3.0

Description

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)

Time Frame

every 3 weeks,up to completion of treatment (approximately 6 months)

Other Pre-specified Outcome Measures:

Title

Serum Epstein-Barr virus (EBV) DNA copies

Time Frame

every 3 weeks,up to completion of treatment (approximately 6 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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); age range from 18 to 70 years; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; at least one measurable lesion; adequate haematologic function (haemoglobin > 8.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l), 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), 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. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and electrocardiogram results. Prior chemotherapy and radiotherapy should have been completed >4 weeks earlier, willingness to provide written informed consent. Exclusion Criteria: mismatch the inclusion criteria systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol. primary lesion not from the upper respiratory

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Zhou, MD.

Organizational Affiliation

Hunan Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hunan Cancer Hospital

City

Changsha

State/Province

Hunan

ZIP/Postal Code

4100013

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs