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

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ClinicalTrials.gov Identifier: NCT02825147
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

Brief 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.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: MESA
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.
Drug: Pegaspargase
Drug: Methotrexate
Drug: Dexamethasone
Drug: Etoposide
Radiation: radiotherapy



Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 21 days after 4 cycles of chemotherapy ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 2-year ]
  2. overall survival [ Time Frame: 2-year ]
  3. 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 ]


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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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China
Shanghai Ruijin Hospital
Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: ZHAO WEILI, PhD,MD Ruijin Hospital
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Responsible Party: Zhao Weili, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02825147    
Other Study ID Numbers: Shanghai Ruijin Hospital
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by Zhao Weili, Ruijin Hospital:
pegaspargase,methotrexate
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, Extranodal NK-T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone
Methotrexate
Etoposide
Pegaspargase
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites