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

Extranodal NK-T-Cell Lymphoma, Nasal Type Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764281
• Other study ID #: XHLSG-NK-1602
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: February 2020

Study information

• Verified date: April 2020
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK-T-Cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• MEDA
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.

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

Locations

Country	Name	City	State
China	Shanghai Dong Fang hospital	Shanghai	Shanghai
China	Shanghai Eye Ear Nose and Throat Hospital, Fudan University	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital	Shanghai	Shanghai
China	Shanghai Tong Ren Hospital	Shanghai	Shanghai
China	Xinhua Hospital	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	Xin Jiang People's Hospital	Urumqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival	Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.	2-year
Secondary	Overall response rate	The overall 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	Treatment-Related Adverse Events as Assessed by CTCAE v4.0	Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.	Day 1 of each course of chemotherapy and then every 3 months for 2 years
Secondary	Overall survival	Overall survival is defiend as the time from entry onto the treatment until death of any reason	2-year