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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
• Intervention / Treatment: Drug: Methotrexate; Drug: Etoposide; Drug: Dexamethasone; Drug: Pegaspargase; Radiation: Radiotherapy

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 Type: Interventional
• Enrollment (Anticipated): 256
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200021
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate	21 days after 4 cycles of chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Weili Zhao, Prof, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2016
• Primary Completion (Actual): March 5, 2021
• Study Completion (Anticipated): July 17, 2022

Study Registration Dates

• First Submitted: November 28, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Dexamethasone; Etoposide; Methotrexate; Pegaspargase
• Other Study ID Numbers: RJ-NK-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No