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

NCT ID: NCT02918747

Last Updated: 2020-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-12-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

P-Gemoxd

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.

Group Type: EXPERIMENTAL

pegaspargase

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

IMRT

Intervention Type: RADIATION

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.

P-CHOP

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.

Group Type: ACTIVE_COMPARATOR

pegaspargase

Intervention Type: DRUG

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.

Cyclophosphamide

Intervention Type: DRUG

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

Doxorubicin

Intervention Type: DRUG

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

Vincristine

Intervention Type: DRUG

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

Prednisone

Intervention Type: DRUG

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

IMRT

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Cyclophosphamide

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

Intervention Type: DRUG

Doxorubicin

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

Intervention Type: DRUG

Vincristine

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

Intervention Type: DRUG

Prednisone

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

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

Oncaspar; Gemzar; Eloxatin; intensity-modulated radiation treatment

Eligibility 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Zhou, MD.

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Locations

Hunan Cancer Hospital

Changsha, Hunan, China

Countries

China

Other Identifiers

HNCH-NKT-2016

Identifier Type: -

Identifier Source: org_study_id