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

NCT02918747 | Unknown Phase 2

• 1 other identifier: HNCH-NKT-2016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

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

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

Other Outcomes (1)

• Serum Epstein-Barr virus (EBV) DNA copies

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

Study Arms (2)

P-Gemoxd

EXPERIMENTAL

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.

Drug: pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Dexamethasone; Radiation: IMRT

P-CHOP

ACTIVE COMPARATOR

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.

Drug: pegaspargase; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Radiation: IMRT

Interventions

pegaspargase 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.

Also known as: Oncaspar

P-CHOP; P-Gemoxd

Gemcitabine DRUG

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

Also known as: Gemzar

P-Gemoxd

Oxaliplatin DRUG

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

Also known as: Eloxatin

P-Gemoxd

Dexamethasone DRUG

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

P-Gemoxd

Cyclophosphamide DRUG

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

P-CHOP

Doxorubicin DRUG

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

P-CHOP

Vincristine DRUG

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

P-CHOP

Prednisone DRUG

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

P-CHOP

IMRT 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.

Also known as: intensity-modulated radiation treatment

P-CHOP; P-Gemoxd

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 4100013, China

Location

MeSH Terms

Conditions

Lymphoma

Interventions

pegaspargase; Gemcitabine; Oxaliplatin; Dexamethasone; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols

Study Officials

• Hui Zhou, MD.

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 29, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)