- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04899414
Dexamethasone, Azacytidine,Pegaspargase and Tislelizumab for NK/T Cell Lymphoma
Study Evaluating the Safety and Efficacy of the Dexamethasone, Azacytidine, Pegaspargase, Tislelizumab With NK/T Cell Lymphoma
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of Dexamethasone, azacytidine, Pegaspargase, Tislelizumab (DAPT) regimen for patients with newly diagnosed advanced stage ENKTL
, non-upper aerodigestive tract NK/T- cell lymphoma(NUAT- NKTCL)and relapsed refractory NK/T cell lymphoma.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Jun Zhu, Dr.
- Phone Number: +86-13910333346
- Email: zhu-jun@bjcancer.org
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Peking University Cancer Hospital & Institute
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Beijing, Beijing, China, 100021
- National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College
-
Contact:
- Yexiong Li, Dr.
-
Beijing, Beijing, China, 100021
- Peking University International Hospital
-
Contact:
- Xiaopei M Wang, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18-70 years ,Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria
- at least one measurable lesion
- hemoglobin ≥90 g/l, absolute neutrophil count ≥ 1.5 × 10^9/L, platelets ≥ 75 ×10^9/L), ALT≤ 2 times upper limit of normal, serum creatinine ≤1.5 times upper limit of normal (If the above indicators are abnormal but are caused by the primary disease as assessed by the clinician, the treatment can be enrolled according to the clinical actual situation)
- There was no other serious disease in conflict with this program
- Adequate respiratory function
- Adequate bone marrow function
- Adequate renal and hepatic function
- Not pregnant or nursing ,negative pregnancy test
- No other active malignancy requiring therapy
- No other serious or life-threatening condition deemed unacceptable by the principal investigator
- Life expectancy ≥ 3 months
- Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
- NK/T cell lymphoma without confirmed pathological diagnosis;
- Patients with early stage upper aerodigestive tract NK/T- cell lymphoma ;
- Patients with drug allergies or metabolic disorders in the program;
- Any uncontrolled medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction);
- Severe infection (excluding the following: HBsAg or anti-HBc positive patients taking entecavir, tenofovir and other drugs;HCV RNA positive but taking direct anti-HCV drugs);
- Invasion of primary or secondary central nervous system tumor invasion;
- Contradictions to chemotherapy or radiotherapy;
- Previously other malignancy requiring therapy;
- Peripheral nervous system disorder or mental disorder;
- Incapacity for legal conduct, medical or ethical reasons that affect the continuation of the research;
- Other clinical investigators;
- Combination of anti-tumor drugs outside the research program;
- Participants evaluated inappropriate to participate in this study by principal investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma
4-6 cycles of induction DAPT followed by Auto HSCT as consolidation for CR/PR fit patients ,then by PD-1 as maintenance treatment (up to 16 cycles) for received Auto-HSCT
|
Dexamethasone 40mg intravenously daily on day 1-4; azacytidine 100mg intravenously daily on day 1-5; Pegaspargase 3750 IU intravenously daily on day 1; Tislelizumab 200 mg IV on Day 1 of each 21-day as a cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: 1-year
|
To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma
|
1-year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2-year
|
2-year
|
Adverse events
Time Frame: 1-year
|
1-year
|
Progression-free survival
Time Frame: 2-year
|
2-year
|
Complete response rate
Time Frame: 1-year
|
1-year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Azacitidine
- Pegaspargase
Other Study ID Numbers
- DAPT for NKTCL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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