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Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma

ConditionExtranodal NK/T-cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCStone Pharmaceuticals

About this trial

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed.

Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy.

Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

Has at least one measurable lesion per Lugano 2014 classification.

Disqualifiers

Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis.

Has known additional malignancy within 5 years prior to randomization.

Has an active autoimmune disease or has had an autoimmune disease that may relapse.

Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sugemalimab

    Biological/Vaccine

    IV infusion

  • Placebo

    Drug

    IV infusion

  • Pegaspargase

    Drug

    Intramuscular injection

  • Gemcitabine

    Drug

    IV infusion

  • Oxaliplatin

    Drug

    IV infusion

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Sugemalimab+PGemOxExperimental treatment 4 interventions
Group B: Placebo+PGemOxPlacebo comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Time frame
Approximately 39 months after First Patient In

Secondary outcomes

1

Overall survival (OS)

Time frame
Approximately 39 months after First Patient In
2

Progression-free survival (PFS) evaluated by the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Time frame
Approximately 39 months after First Patient In
3

Objective response rate (ORR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Time frame
Approximately 39 months after First Patient In
4

Duration of response (DoR) evaluated by BICR and the Investigator according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification

Time frame
Approximately 39 months after First Patient In

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CStone Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: