Back to resultsMEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
Primary Purpose
Extranodal NK-T-Cell Lymphoma, Nasal Type
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MEDA
Auto-HSCT
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK-T-Cell Lymphoma, Nasal Type
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- Shanghai Ninth People's Hospital
- Shanghai Eye Ear Nose and Throat Hospital, Fudan University
- Zhongshan Hospital, Fudan University
- Xinhua Hospital
- Shanghai Dong Fang hospital
- Shanghai Tong Ren Hospital
- Xin Jiang People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MEDA/Auto-HSCT
Arm Description
Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT).
Outcomes
Primary Outcome Measures
Complete response rate
The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Secondary Outcome Measures
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Overall response rate
The overall response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Full Information
NCT ID
NCT02764281
First Posted
April 29, 2016
Last Updated
April 24, 2020
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02764281
Brief Title
MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
Official Title
The Efficacy and Safety of Methotrexate, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (MEDA) With Autologous HSCT in the Treatment of Stage IV Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based chemotherapy improved overall response and prolonged the long-term survival for patients with stage IV. But the optimal treatment schedule has not been established. This study is designed with four cycles MEDA chemotherapy, followed by Auto-HSCT for stage IV patients with newly onset, relapsed or refractory diseases. The efficacy and safety of this protocol in the treatment of will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK-T-Cell Lymphoma, Nasal Type
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDA/Auto-HSCT
Arm Type
Experimental
Arm Description
Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT).
Intervention Type
Drug
Intervention Name(s)
MEDA
Other Intervention Name(s)
Methotrexate, Etoposide,Dexamethasone,Pegaspargase
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Auto-HSCT
Intervention Description
Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.
Primary Outcome Measure Information:
Title
Complete response rate
Description
The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Time Frame
Day 28 of the 4th course of MEDA chemotherapy
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Time Frame
2-year
Title
Overall response rate
Description
The overall response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Time Frame
Day 28 of the 4th course of MEDA chemotherapy
Title
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Description
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Time Frame
Day 1 of each course of chemotherapy and then every 3 months for 2 years
Title
Overall survival
Description
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Time Frame
2-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Tao, MD
Organizational Affiliation
Xinhua hospital, Shanghai Jiao Tong University of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Facility Name
Shanghai Eye Ear Nose and Throat Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Xinhua Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Shanghai Dong Fang hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Shanghai Tong Ren Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Facility Name
Xin Jiang People's Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
We'll reach out to this number within 24 hrs