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

June 15, 2023 updated by: Hua Wang, Sun Yat-sen University

Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hua Wang, MD.

Study Locations

  • China
    • Please Select
      • Guangzhou, Please Select, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: up to end of follow-up-phase (approximately 3 years)
up to end of follow-up-phase (approximately 3 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: up to end of follow-up-phase (approximately 3 years)
up to end of follow-up-phase (approximately 3 years)
complete remission rate
Time Frame: every 3 weeks,up to completion of chemotherapy(approximately 3months)
every 3 weeks,up to completion of chemotherapy(approximately 3months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time Frame: up to end of follow-up-phase (approximately 3 years)
including hematological safety and non-hematological safety
up to end of follow-up-phase (approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

China Food and Drug Administration

Investigators

  • Principal Investigator: Hua Wang, MD., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimated)

March 10, 2016

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NK-SYSUCC-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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