Dexamethasone, Azacytidine,Pegaspargase and Tislelizumab for NK/T Cell Lymphoma

NCT04899414 | Unknown Phase 2

• 1 other identifier: DAPT for NKTCL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

NK/T Cell Lymphoma

Keywords

DAPT; Tislelizumab; Non- upper aerodigestive tract NK/T- cell lymphoma; R/R NK/T- cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  To evaluate the overall response rate of DAPT in the treatment of NK/T cell lymphoma

  1-year

Secondary Outcomes (4)

• Complete response rate

  1-year

• Progression-free survival

  2-year

• Overall survival

  2-year

• Adverse events

  1-year

Study Arms (1)

Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma

EXPERIMENTAL

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

Drug: Dexamethasone, azacytidine, Pegaspargase, Tislelizumab

Interventions

Dexamethasone, azacytidine, Pegaspargase, Tislelizumab DRUG

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.

Stage III/IV or Stage I/II NUAT- NKTCL or Relapsed or Refractory NK/T- cell lymphoma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (3)

National Cancer Center/Cancer Hosptial, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, 100021, China

Location

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Dexamethasone; Azacitidine; pegaspargase; tislelizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Jun Zhu, Dr.

CONTACT

+86-13910333346; zhu-jun@bjcancer.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: May 18, 2021
• Primary Completion: May 18, 2023
• Study Completion: October 18, 2023
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)