NCT04096690

Brief Summary

This open-label, single arm study will evaluate the efficacy and safety of anti-PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

September 18, 2019

Last Update Submit

March 9, 2020

Conditions

Nasal Type Extranodal NK/T-Cell Lymphoma

Keywords

Anti-PD-1 antibodyNasal Type Extranodal NK/T-Cell LymphomaComplete response rateSafety

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

    Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.

    At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (8)

  • Overall response rate

    At the end of Cycle 6 (each cycle is 21 days)

  • Progression free survival

    Baseline up to data cut-off (up to approximately 4 years)

  • Overall survival

    Baseline up to data cut-off (up to approximately 4 years)

  • Duration of response

    Baseline up to data cut-off (up to approximately 4 years)

  • EBV-DNA load change

    End of induction treatment (approximately 1 year)

  • +3 more secondary outcomes

Other Outcomes (1)

  • Circulating free Deoxyribonucleic Acid (cfDNA) monitoring

    Baseline up to data cut-off (up to approximately 4 years)

Study Arms (1)

Anti-PD-1 antibody plus pegaspargase

EXPERIMENTAL

Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)

Drug: PegaspargaseDrug: Anti-PD-1 monoclonal antibody

Interventions

PegaspargaseDRUG

Pegaspargase 3750IU administered by intramuscular injection on Day 1 of each 21-day cycle for 6 cycles in induction treatment

Anti-PD-1 antibody plus pegaspargase
Anti-PD-1 monoclonal antibodyDRUG

Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 2 of each 21-day cycle for 6 cycles in induction treatment Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1 of each 21-day cycle for up to 28 cycles in maintenance treatment

Also known as: Tyvyt
Anti-PD-1 antibody plus pegaspargase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed NK/T cell lymphoma based on 2016 WHO classification
  • Treatment naive
  • Age \> 18 years
  • Advanced stage
  • Must has measurable lesion in CT or PET-CT prior to treatment
  • ECOG 0,1,2
  • Informed consented

You may not qualify if:

  • Aggressive NK/T-cell leukemia
  • Has accepted PD-1,PD-L1 or PD-L2 antibody before
  • Has accepted autologous Stem cell transplantation before
  • History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Primary CNS lymphoma
  • Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<50\*10\^9/L; ALT or AST \>3\*ULN; Creatinine\>2\*ULN
  • Other uncontrollable medical condition that may that may interfere the participation of the study
  • Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
  • HIV infection
  • HBV-DNA or HCV-RNA positive
  • Diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose.
  • Received attenuated live vaccine 4 weeks prior to first dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

pegaspargasespartalizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasms

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
First Deputy Director，Hematology Department

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

September 10, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

CN(1)