MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma

NCT02764281 | Completed

• 1 other identifier: XHLSG-NK-1602
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide, pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.

Conditions

Extranodal NK-T-Cell Lymphoma, Nasal Type

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.

  Day 28 of the 4th course of MEDA chemotherapy

Secondary Outcomes (4)

• Progression free survival

  2-year

• Overall response rate

  Day 28 of the 4th course of MEDA chemotherapy

• Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Day 1 of each course of chemotherapy and then every 3 months for 2 years

• Overall survival

  2-year

Study Arms (1)

MEDA/Auto-HSCT

EXPERIMENTAL

Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT).

Drug: MEDA; Procedure: Auto-HSCT

Interventions

MEDA DRUG

Methotrexate, 3.0g/m2/d iv, day 1 Etoposide, 100mg/m2 iv, day 2 to day 4 Dexamethasone, 40mg/d iv, day 1 to day 4 Pegaspargase, 2500IU/m2/d im, day 4 The MEDA chemotherapy will be repeated every 3 weeks.

Also known as: Methotrexate, Etoposide,Dexamethasone,Pegaspargase

MEDA/Auto-HSCT

Auto-HSCT PROCEDURE

Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.

MEDA/Auto-HSCT

Eligibility Criteria

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

You may qualify if:

• Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.
• Eastern Cooperative Oncology Group (ECOG ) performance status 0\~3.
• Stage IV disease with at least one measurable lesion.
• Preserved organ functions for: Platelet\>50×10\*9/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<3×ULN, alanine transaminase (ALT)\<5×ULN, serum creatinine (Cr)\<1.5×ULN, fibrinogen≥0.5g/L, LVEF≥50%.
• Signed Informed consented.

You may not qualify if:

• Relapsed or progressive disease to prior L-asparaginase-based chemotherapy.
• Concurrent cancers need surgery or chemotherapy within 6 months.
• History of chemotherapy or radiotherapy for other solid cancers within 3 years.
• Recent history of radiotherapy of upper-aero-digestive tract within last 3 months.
• Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, severe hemophagocytic lymphohistiocytosis.
• Mental disorders.
• Pregnant or lactation.
• HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥10\*5 copies/ml.
• History of pancreatitis.
• Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.
• Enrolled in other trial treatment.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (7)

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai Eye Ear Nose and Throat Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

Shanghai Dong Fang hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Shanghai Tong Ren Hospital

Shanghai, Shanghai Municipality, 200336, China

Location

Xin Jiang People's Hospital

Ürümqi, Xinjiang, 830001, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Methotrexate; Etoposide

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; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Rong Tao, MD

  Xinhua hospital, Shanghai Jiao Tong University of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 6, 2016
• Study Start: April 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)