PEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02705508
Collaborator
China Food and Drug Administration (Other)
35
Enrollment
1
Location
1
Arm
70
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 PEG-ASP at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.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 were given for a maximum of six cycles.Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after achieving CR for advanced stage and refractory/relapsed patients

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma
Study Start Date :
Feb 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: PEG group

Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500U/m2 Pegaspargase at three different sites.The regimen was repeated every 3 weeks.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 were given for a maximum of six cycles.

Drug: Gemcitabine
1000mg/m2, ivd on day 1 and 8 of each 21 day cycle.
Other Names:
  • Gemzar
  • Drug: etoposide
    100mg/m2,4h-intravenous infusion on day1-3 of each 21 day cycle.
    Other Names:
  • Etoposide phosphate
  • Drug: Pegaspargase
    2500U/m2 im on day 1 of each 21 day cycle.
    Other Names:
  • Oncaspar
  • Radiation: involved-field radiotherapy
    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.
    Other Names:
  • IFRT
  • Outcome Measures

    Primary Outcome Measures

    1. progression free survival [up to end of follow-up-phase (approximately 3 years)]

    Secondary Outcome Measures

    1. overall survival [up to end of follow-up-phase (approximately 3 years)]

    2. complete remission rate [every 3 weeks,up to completion of chemotherapy(approximately 3months)]

    Other Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) [up to end of follow-up-phase (approximately 3 years)]

      including hematological safety and non-hematological safety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification;

    2. age≥18 years;

    3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

    4. at least one measurable lesion;

    5. adequate haematologic function (haemoglobin > 9.0 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. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);

    8. normal coagulation function and electrocardiogram results.

    9. Prior chemotherapy and radiotherapy should have been completed >4 weeks 10.earlier,willingness to provide written informed consent.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Sun Yat-sen University Cancer CenterGuangzhouPlease SelectChina510060

    Sponsors and Collaborators

    • Sun Yat-sen University
    • China Food and Drug Administration

    Investigators

    • Principal Investigator: hua wang, MD., Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    wanghua, professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT02705508
    Other Study ID Numbers:
    • NK-SYSUCC-2016
    First Posted:
    Mar 10, 2016
    Last Update Posted:
    Dec 19, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by wanghua, professor, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 19, 2020