Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02825147|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nasal Type Extranodal NK/T-Cell Lymphoma||Drug: Pegaspargase Drug: Methotrexate Drug: Dexamethasone Drug: Etoposide Radiation: radiotherapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||July 2017|
stage I/II: methotrexate 1000mg/m2,d1 dexamethasone 40mg,d2-d4 etoposide 100mg,d2-d4 pegaspargase 2500U/m2,d5 a cycle of every 21 days with totally 4 cycles Radiotherapy at least 50Gy in dose for the involved local focus is sandwiched after 2 cycles.
- Overall response rate [ Time Frame: 21 days after 4 cycles of chemotherapy ]
- Progression free survival [ Time Frame: 2-year ]
- overall survival [ Time Frame: 2-year ]
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Day 1 of each course and then every 3 months for 1 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825147
|Shanghai Ruijin Hospital|
|Shanghai, China, 200025|
|Principal Investigator:||ZHAO WEILI, PhD,MD||Ruijin Hospital|