Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 12:15 AM
Study NCT ID:
NCT06848569
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sintilimab Plus AVD in Pediatric Low/Moderate Risk Hodgkin Lymphoma: A Phase II Study
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Prospective, Single-Arm, Multicenter, Phase II Study of Sintilimab in Combination With AVD for Pediatric and Adolescent Low/Moderate Risk Classical Hodgkin Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Purpose: To evaluate the efficacy and safety of sintilimab in combination with AVD chemotherapy for the treatment of pediatric and adolescent patients with low-to-intermediate risk classical Hodgkin lymphoma (cHL).
Study Design: This is a prospective, single-arm, multicenter, phase II clinical trial.
Study Population: Pediatric and adolescent patients aged 1 to 18 years, diagnosed with classical Hodgkin lymphoma, and classified as low-to-intermediate risk according to the Ann Arbor staging system.
Treatment Plan: Sintilimab in combination with AVD chemotherapy, administered every two weeks for a planned 4-6 cycles.
Study Design: This is a prospective, single-arm, multicenter, phase II clinical trial.
Study Population: Pediatric and adolescent patients aged 1 to 18 years, diagnosed with classical Hodgkin lymphoma, and classified as low-to-intermediate risk according to the Ann Arbor staging system.
Treatment Plan: Sintilimab in combination with AVD chemotherapy, administered every two weeks for a planned 4-6 cycles.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: