Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma

Nasal Type Extranodal NK/T-Cell Lymphoma Clinical Trial

Official title:

Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825147
• Other study ID #: Shanghai Ruijin Hospital
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2015
• Last updated: November 10, 2017
• Start date: September 2013
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients. Asparaginase-based treatment has been demonstrated as promising response rate and survival superiority. Stage-specified regimen may bring out exciting efficacy with good safety.

Description:

Extranodal NK/T cell lymphoma is a kind of tumor more prevalent in Asia and South America than that in the Western world, which is almost invariably EBV- associated and often presents as localized disease in and around the nasal structures. The disease frequency was higher in Asian countries with no differences in age, gender or immunophenotypic profile between nasal and extranasal cases. EBV is a constant finding, particularly in the cases presenting as localized nasal disease and assumed involved in the pathogenesis. During the past decades the disease, historically termed as "lethal midline granuloma" was very aggressive with poor survival. Five-year OS for extra-nasal disease is reported as 9% compared to 42% for localized disease.

Although radiotherapy combined with or without anthracycline-based chemotherapy has been considered as the treatment for extranodal NK/T cell lymphoma in the past, numerous data suggest that this tumor is not very chemosensitive due to the p-glycoprotein expression, which may mediate the drug resistance. CHOP/CHOP-like schedules presented with low CR rates and frequent failures during chemotherapy. Disseminated involvement is much poorer in prognosis than localized disease with the latter is benefit more from radiotherapy.

In the nearest ten years, many new agents have been used in the treatment of extranodal NK/T cell lymphoma, in which the most promising one is asparaginase. Asparaginase-containing regiment has demonstrated about 50% responses rates and 5-year overall survival of 65% in relapsed or refractory disease. The impressive outcome indicates its value in the newly diagnosed patients, especially in the disseminated cases. Pegaspargase as a new form of asparaginase displays equivalent bioactivity as L- asparaginase with longer half-time and lower incidence of allergy. Its clinical efficacy has been verified in the patients with acute lymphocytic leukemia.

The purpose of this study is to evaluate the efficacy and safety of pegaspargase and methotrexate based regimens with or without radiotherapy in the newly diagnosed patients with extranodal NK/T cell lymphoma, including localized and disseminated cases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pegaspargase

• Methotrexate

• Dexamethasone

• Etoposide

Radiation:
• radiotherapy

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		21 days after 4 cycles of chemotherapy
Secondary	Progression free survival		2-year
Secondary	overall survival		2-year
Secondary	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 1 years