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

NCT02085655 | Unknown Phase 3 DMC

• 1 other identifier: NKT-SYSUCC-2013
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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 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

Keywords

Extranodal NK/T-cell lymphoma; PA-Gemox regimen; thalidomide

Outcome Measures

Primary Outcomes (1)

• Efficacy Outcome Measure

  Study group increase 15% 2-year PFS

  up to 24 months

Secondary Outcomes (1)

• Safety/Adverse Event Outcome Measure

  Up to 36 months

Other Outcomes (1)

• Efficacy Outcome Measure

  Up to 36 months

Study Arms (2)

PEG-ASP+Gemox regimen group

EXPERIMENTAL

PEG-ASP 2000U/m2 im d1 Gemcitabine 800mg/m2 ivdrip 30min d1，8 Oxaliplatin 100mg/m2 ivdrip d1 Thalidomide 150-200mg po qn d8-21

Drug: pegaspargase; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Thalidomide

AspaMetDex regimen group

ACTIVE COMPARATOR

Pegaspargase 2000U/m2 im， d1 methotrexate 3000m g/m2 civ 6-hour，d1, Calcium folinate 30mg iv q6h x6 Dexamethasone 40 mg ivdrip QD

Drug: pegaspargase; Drug: Methotrexate; Drug: Dexamethasone

Interventions

pegaspargase DRUG

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

Also known as: Oncaspar

AspaMetDex regimen group; PEG-ASP+Gemox regimen group

Gemcitabine DRUG

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

Also known as: Gemzar

PEG-ASP+Gemox regimen group

Oxaliplatin DRUG

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

Also known as: Eloxatin

PEG-ASP+Gemox regimen group

Methotrexate DRUG

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

AspaMetDex regimen group

Dexamethasone DRUG

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

AspaMetDex regimen group

Thalidomide DRUG

100-200mg, PO, after chemotherapy

PEG-ASP+Gemox regimen group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification;
• age≥18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• at least one measurable lesion;
• adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l),
• 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),
• adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
• normal coagulation function and electrocardiogram results.
• Prior chemotherapy and radiotherapy should have been completed \>4 weeks earlier,
• willingness to provide written informed consent.

Sponsors & Collaborators

• Huiqiang Huang: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Department of Medical Oncology, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

pegaspargase; Gemcitabine; Oxaliplatin; Methotrexate; Dexamethasone; Thalidomide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles

Study Officials

• HuiQiang Huang

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

HuiQiang Huang

CONTACT

86-020-87343350; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: April 25, 2013
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 15, 2021

Record last verified: 2021-03

Locations

CN (1)