MESA Versus ESA in the Treatment of Early Stage NK/T-cell Lymphoma

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

Official title:

The Efficacy and Safety of Etoposide, Dexamethasone, Peg-asparaginase or Plus Methotrexate With Sandwiched Radiotherapy in the Treatment of Stage I to II Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02631239
• Other study ID #: RJ-NK-2015
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 16, 2016
• Est. completion date: July 17, 2022

Study information

• Verified date: August 2021
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. Radiotherapy plus chemotherapy has improved the survival for these patients. But the optimal treatment schedule is controversial. The previous protocols usually contained high dose methotrexate, but the application of them is limited for the toxicity.

Description:

In mid-2016, we had the final evaluation of the phase 2 study of MESA with sandwiched radiotherapy in newly diagnosed early stage NKTCL (NCT02825147). We obtained the final overall response rate of MESA with sandwiched radiotherapy, while the 2-year progression free survival rate was not available at that timepoint. To make the study design of sample size more accurate, we changed the primary outcome endpoint from 2-year progression free survival rate to overall response rate. The change had been approved by the Ethics Committee in August 10, 2016. At that time, only fourteen patients were enrolled in NCT02631239.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: July 17, 2022
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• Methotrexate
1g/m2/d IV *1d
• Etoposide
200mg/d PO *3d
• Dexamethasone
40mg/d PO *3d
• Pegaspargase
2500IU/m2/d IM *1d

Radiation:
• Radiotherapy
50-56Gy

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		21 days after 4 cycles of chemotherapy
Secondary	Overall survival		2-year
Secondary	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 2 years
Secondary	Progression free survival		2-year