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PEG-ASP+Gemox Regimen and Thalidomide for NK/T Lymphoma

NCT02085655 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2021-03-15

No results posted yet for this study

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 long-acting aspargase (pegylated aspargase, PEG-ASP) combined with gemcitabine and oxaliplatin (PASP -Gemox) treatment in this population.

Conditions

  • Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

Interventions

DRUG

pegaspargase

pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

Gemcitabine

1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

Oxaliplatin

100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops

DRUG

Methotrexate

3000m g/m2 civ 6-hour on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

Dexamethasone

40mg ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

Thalidomide

100-200mg, PO, after chemotherapy

Sponsors & Collaborators

  • Sun Yat-sen University

    collaborator OTHER

  • Huiqiang Huang

    lead OTHER

Principal Investigators

  • HuiQiang Huang · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-25
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02085655 on ClinicalTrials.gov