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

Sponsor

Ruijin Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02631239

Collaborator

(none)

256

Enrollment

Location

Arms

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK/T-cell Lymphoma, Nasal Type	Drug: Methotrexate Drug: Etoposide Drug: Dexamethasone Drug: Pegaspargase Radiation: Radiotherapy	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 16, 2016

Actual Primary Completion Date :

Mar 5, 2021

Anticipated Study Completion Date :

Jul 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MESA Methotrexate, etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy	Drug: Methotrexate 1g/m2/d IV 1d Drug: Etoposide* 200mg/d PO 3d Drug: Dexamethasone* 40mg/d PO 3d Drug: Pegaspargase* 2500IU/m2/d IM 1d Radiation: Radiotherapy* 50-56Gy
Experimental: ESA Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy	Drug: Etoposide 200mg/d PO 3d Drug: Dexamethasone* 40mg/d PO 3d Drug: Pegaspargase* 2500IU/m2/d IM 1d Radiation: Radiotherapy* 50-56Gy

Arm

Intervention/Treatment

Active Comparator: MESA

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

Drug: Methotrexate

1g/m2/d IV *1d

Drug: Etoposide

200mg/d PO *3d

Drug: Dexamethasone

40mg/d PO *3d

Drug: Pegaspargase

2500IU/m2/d IM *1d

Radiation: Radiotherapy

50-56Gy

Experimental: ESA

Etoposide, dexamethasone, Peg-asparaginase and sandwiched radiotherapy

Drug: Etoposide

200mg/d PO *3d

Drug: Dexamethasone

40mg/d PO *3d

Drug: Pegaspargase

2500IU/m2/d IM *1d

Radiation: Radiotherapy

50-56Gy

Outcome Measures

Primary Outcome Measures

Overall response rate [21 days after 4 cycles of chemotherapy]

Secondary Outcome Measures

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 2 years]
Progression free survival [2-year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >3ULN, AKP or bilirubin >2.5ULN Creatinine>1.5*ULN
Not able to comply to the protocol for mental or other unknown reasons
Pregnant or lactation
HIV infection