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P-Gemox Regimen as First-line Chemotherapy in NK/T Lymphoma Patiens

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ClinicalTrials.gov Identifier: NCT02533323
Recruitment Status : Terminated
First Posted : August 26, 2015
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
dr. luyue, Sun Yat-sen University

Brief Summary:
This prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and Pegaspargase (P-Gemox) in newly diagnosed, nasal type, extranodal natural killer/T-cell lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma, Extranodal NK-T-Cell Drug: gemcitabine Drug: oxaliplatin Drug: pegaspargase Phase 2

Detailed Description:
Treatment P-Gemox dosages were as follows: days 1, 30 min intravenous infusion of 1250 mg/m2 gemcitabine; day 1, 2h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 U/m2 PEG-ASP at three different sites. The regimen was repeated every 2 weeks for a maximum of six cycles. Stage IE/IIE patients underwent four cycles induction chemotherapy, 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. Stage IIIE/IVE patients patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Primary tumor radiotherapy was recommended after they achieved CR.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Pegaspargase-Gemox Chemotherapy in Newly Diagnosed, Nasal Type, Extranodal Natural Killer/T-cell Lymphoma
Study Start Date : January 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : January 2017


Arm Intervention/treatment
Experimental: P-Gemox
P-Gemox:gemcitabine :1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days.
Drug: gemcitabine
gemcitabine :1250mg/m2 (ivdrip) on days 1
Other Name: Gemzar

Drug: oxaliplatin
oxaliplatin :85 mg/m2 (ivdrip) on day 1
Other Name: Eloxatin

Drug: pegaspargase
pegaspargase : 2500 IU/m2 (intramuscular injection)
Other Name: Oncaspar




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. complete remission rate [ Time Frame: every 4 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. 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

  3. safety, as measured by adverse events [ Time Frame: up to end of follow-up-phase (approximately 3 years) ]
    ncluding hematological safety and non-hematological safety.All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

  4. serum soluble programmed death ligand 1 [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    Soluble PD-L1 is measured using an enzyme-linked immunosorbent assay

  5. serum interleukin 15 [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    serum interleukin 15 is measured using an enzyme-linked immunosorbent assay

  6. Serum ferritin level [ Time Frame: every 3 weeks,up to completion of treatment(approximately 6 months) ]
    Serum ferritin level is measured using radioimmunoassay



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed ENKTL
  • age:18-80years
  • at lease one measurable lesion
  • receive no chemotherapy or radiotherapy before
  • Eastern CooperativeOncology Group performance status of 0 to 2.
  • Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

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.

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): NCT02533323


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
GuangZhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: yue lu, MD. Department of Hematological Oncology, Sun Yat-sen University Cancer Center

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Responsible Party: dr. luyue, professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02533323     History of Changes
Other Study ID Numbers: SYSUCC-NK/T-5010
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: October 2016

Keywords provided by dr. luyue, Sun Yat-sen University:
NK/T-cell lymphoma
induction chemotherapy
survival

Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Neoplasms
Lymphoma
Lymphoma, Extranodal NK-T-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Gemcitabine
Oxaliplatin
Pegaspargase
Asparaginase
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs