Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma

NCT02825147 | Completed Phase 2

• 1 other identifier: Shanghai Ruijin Hospital
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients. Asparaginase-based treatment has been demonstrated as promising response rate and survival superiority. Stage-specified regimen may bring out exciting efficacy with good safety.

Conditions

Nasal Type Extranodal NK/T-Cell Lymphoma

Keywords

pegaspargase,methotrexate

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  21 days after 4 cycles of chemotherapy

Secondary Outcomes (3)

• Progression free survival

  2-year

• overall survival

  2-year

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Day 1 of each course and then every 3 months for 1 years

Study Arms (1)

MESA

EXPERIMENTAL

stage I/II: methotrexate 1000mg/m2,d1 dexamethasone 40mg,d2-d4 etoposide 100mg,d2-d4 pegaspargase 2500U/m2,d5 a cycle of every 21 days with totally 4 cycles Radiotherapy at least 50Gy in dose for the involved local focus is sandwiched after 2 cycles.

Drug: Pegaspargase; Drug: Methotrexate; Drug: Dexamethasone; Drug: Etoposide; Radiation: radiotherapy

Interventions

Pegaspargase DRUG

MESA

Methotrexate DRUG

MESA

Dexamethasone DRUG

MESA

Etoposide DRUG

MESA

radiotherapy RADIATION

MESA

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of extranodal NK/T cell lymphoma, nasal type, previously untreated
• Age 14 \~ 70 years old
• ECOG(Eastern Cooperative Oncology Group）performance status 0\~2
• Stage I to II
• Life expectancy\>6 months
• Informed consented

You may not qualify if:

• Chemotherapy before
• Bone marrow transplantation before
• History of malignancy
• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
• LVEF≤50%
• Other uncontrollable medical condition that may that may interfere the participation of the study
• Lab at enrollment ALT or AST \>3\*ULN, AKP or bilirubin \>2.5\*ULN Creatinine\>1.5\*ULN
• Not able to comply to the protocol for mental or other unknown reasons
• Pregnant or lactation
• HIV infection

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

pegaspargase; Methotrexate; Dexamethasone; Etoposide; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Glucosides; Glycosides; Carbohydrates; Therapeutics

Study Officials

• ZHAO WEILI, PhD,MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2015
• First Posted: July 7, 2016
• Study Start: September 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

CN (1)