Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK/T-Cell Lymphoma

Browse trials for

• Lymphoma 5,578
• Lymphoma, T-Cell 718
• Lymphoma, T-Cell, Peripheral 604
• Lymphoma, Extranodal NK-T-Cell 179

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 49 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Study arms

• Experimental
  P-P-GemOx arm

  Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen

  Drug: Immunochemotherapy

Interventions

• DrugImmunochemotherapy

  P-P-GemOx regimen Sintilimab 200mg iv D1; Pegaspargase 3750U im D1; GemOx regimen: Gemcitabine 1000mg/m2 iv D1, Oxaliplatin 100mg/m2 iv D1 This regimen is administered every 3 weeks. For patients with stage I-II (localized) disease: A sandwich approach incorporating radiotherapy is employed. Patients initially receive 2 cycles of the P-P-GemOx regimen. If the interim evaluation demonstrates a complete response (CR) or partial response (PR), patients will proceed to intensity-modulated radiotherapy (IMRT). Following radiotherapy, an additional 2 cycles of the P-P-GemOx regimen are administered. For patients with stage III-IV (advanced) disease. Patients are planned to receive 6 cycles of the P-P-GemOx regimen. For those achieving CR or PR following 6 cycles of immunochemotherapy, subsequent treatment options include autologous hematopoietic stem cell transplantation (auto-HSCT) or PD-1 monoclonal antibody maintenance therapy, determined based on age and overall physical condition.

Primary outcomes

1. Complete response rate (CRR)

   Treatment responses were assessed according to the 2014 Lugano classification criteria.

   Time frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)

Secondary outcomes

1. Progression-free survival (PFS)

   Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.

   Time frame: From date of enrollment until documented disease progression or death of any reason (up to 3 years).

2. Overall survival

   Overall survival was defined as the time from the date of enrollment to the date of death from any cause.

   Time frame: From date of enrollment until documented death of any reason (up to 3 years).

3. Overall response rate

   The ORR was defined as the proportion of patients with CR or PR.

   Time frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).

4. Adverse event

   Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

   Time frame: From enrollment till 28 days post the last induction cycle.

Individual participant data

Plan to share: No