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

NCT ID: NCT02631239

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-16
• Study Completion Date: 2022-07-17

Brief 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.

Detailed 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.

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MESA

Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy

Group Type: ACTIVE_COMPARATOR

Methotrexate

Intervention Type: DRUG

1g/m2/d IV \*1d

Etoposide

Intervention Type: DRUG

200mg/d PO \*3d

Dexamethasone

Intervention Type: DRUG

40mg/d PO \*3d

Pegaspargase

Intervention Type: DRUG

2500IU/m2/d IM \*1d

Radiotherapy

Intervention Type: RADIATION

50-56Gy

ESA

Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy

Group Type: EXPERIMENTAL

Etoposide

Intervention Type: DRUG

200mg/d PO \*3d

Dexamethasone

Intervention Type: DRUG

40mg/d PO \*3d

Pegaspargase

Intervention Type: DRUG

2500IU/m2/d IM \*1d

Radiotherapy

Intervention Type: RADIATION

50-56Gy

Interventions

Methotrexate

1g/m2/d IV \*1d

Intervention Type: DRUG

Etoposide

200mg/d PO \*3d

Intervention Type: DRUG

Dexamethasone

40mg/d PO \*3d

Intervention Type: DRUG

Pegaspargase

2500IU/m2/d IM \*1d

Intervention Type: DRUG

Radiotherapy

50-56Gy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weili Zhao, Prof

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

RJ-NK-2015

Identifier Type: -

Identifier Source: org_study_id