Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05253495
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2022-02-14
Brief Title:
Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma
Sponsor:
New York Medical College
Organization:
New York Medical College
Study Overview
Official Title:
Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure From Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children Adolescents and Young Adults With Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-10
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:
RADICAL
Brief Summary:
The addition of targeted immunotherapy will be safe and well tolerated and facilitate the reduction of anthracycline exposure while preserving lymphoma disease control in children adolescents and young adults CAYA with mature B-cell non-Hodgkin lymphoma MB-NHL and classical Hodgkin lymphoma cHL
Detailed Description:
The primary objective is 1 to determine feasibility and safety as defined by dose limiting toxicities DLTs of adding polatuzumab vedotin Pv in combination with rituximab RTX containing French-American-British FAB chemoimmunotherapy with reduced dose anthracycline in CAYA with intermediate and high risk newly diagnosed MB-NHL 2 To define the feasibility and safety as defined by DLTs of the addition of nivolumab to the backbone of reduced toxicity chemoimmunotherapy with brentuximab vedotin Bv vinblastine dacarbazine and rituximab with reduced dose anthracycline in CAYA with newly diagnosed intermediate and high risk cHL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None