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

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ClinicalTrials.gov Identifier: NCT02918747
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hunan Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: pegaspargase Drug: Gemcitabine Drug: Oxaliplatin Drug: Dexamethasone Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Radiation: IMRT Phase 3

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 two 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 3 Study
Study Start Date : September 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 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.

Drug: pegaspargase
2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: four.
Other Name: Oncaspar

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

Drug: Oxaliplatin
85 mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: four
Other Name: Eloxatin

Drug: Dexamethasone
15 mg, Ivd on day 1 to day 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.
Other Name: intensity-modulated radiation treatment

Active Comparator: P-CHOP

Pegaspargase+Cyclophosphamide+Doxorubicin+Vincristine +Prednisone (P-CHOP):Patients received the P-CHOP chemotherapy regimen every 3 weeks. Pegaspargase 2000U/m2 im,day 1; cyclophosphamide 750 mg/m2,ivdrip day 1; doxorubicin 50mg/m 2,ivdrip day 1;vincristine 1.4 mg/m 2(≤2mg),ivdrip day 1 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
2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: four.
Other Name: Oncaspar

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.
Other Name: intensity-modulated radiation treatment




Primary Outcome Measures :
  1. Objective response rate(complete remission rate + partial remission rate) [ Time Frame: every 6 weeks,up to completion of treatment (approximately 6 months) ]
    The criteria for the efficacy evaluation (overall response rate and complete remission) of the regimen is according to the following article: Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244.

  2. progression free survival [ Time Frame: up to end of follow-up-phase (approximately 3 years) ]
    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

  3. overall survival [ Time Frame: up to end of follow-up-phase (approximately 3 years) ]
    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 :
  1. Incidence of Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events v3.0 [ Time Frame: every 3 weeks,up to completion of treatment (approximately 6 months) ]
    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)


Other Outcome Measures:
  1. Serum Epstein-Barr virus (EBV) DNA copies [ Time Frame: every 3 weeks,up to completion of treatment (approximately 6 months) ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918747


Contacts
Contact: Pingyong Yi, MD. (86-0731)89762281 yipingy1964@163.com
Contact: Yajun Li, MD. (86-0731)89762281 liyajun9@aliyun.com

Locations
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China, 4100013
Contact: Pingyong Yi, MD.    (86-0731)89762281    yipingy1964@163.com   
Principal Investigator: Pingyong Yi, MD.         
Sponsors and Collaborators
Hunan Cancer Hospital
Investigators
Principal Investigator: Pingyong Yi, MD. Hunan Cancer Hospital

Responsible Party: Hunan Cancer Hospital
ClinicalTrials.gov Identifier: NCT02918747     History of Changes
Other Study ID Numbers: HNCH-NKT-2016
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
Gemcitabine
Oxaliplatin
Liposomal doxorubicin
Pegaspargase
Cyclophosphamide
Doxorubicin
Vincristine
Asparaginase
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents