Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-27 @ 11:24 AM
Study NCT ID:
NCT04795869
Status:
WITHDRAWN
Last Update Posted:
2023-10-10
First Post:
2021-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brentuximab Vedotin and Pembrolizumab in Treating Patients With Recurrent Peripheral T-Cell Lymphoma
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Phase II Study of Brentuximab Vedotin in Combination With Pembrolizumab in Patients With Recurrent Systemic Peripheral T-Cell Lymphoma (PTCL)
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study inactivated due to zero accruals
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II clinical trial studies how well giving brentuximab vedotin together with pembrolizumab in treating patients with peripheral T-cell lymphoma (PTCL) that has come back (recurrent). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Pembrolizumab is an antibody-drug that stimulates body's natural antitumor immune responses. Giving brentuximab vedotin together with pembrolizumab may work better than brentuximab vedotin alone in treating patients with recurrent peripheral T-cell lymphoma.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the antineoplastic efficacy of brentuximab vedotin in combination with pembrolizumab in previously treated patients with PTCL, as measured by the overall objective response rate (ORR).
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of brentuximab vedotin in combination with pembrolizumab.
II. To assess efficacy using duration of objective response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS).
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, and pembrolizumab IV over 30 minutes on day 3 of cycle 1, day 1 of subsequent cycles. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles of treatment, patients may discontinue treatment if they experience disease progression, are eligible for stem cell transplant, or if they elect to not undergo stem cell transplantation (SCT).
After completion of study treatment, patients are followed up to 5 years.
I. To assess the antineoplastic efficacy of brentuximab vedotin in combination with pembrolizumab in previously treated patients with PTCL, as measured by the overall objective response rate (ORR).
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of brentuximab vedotin in combination with pembrolizumab.
II. To assess efficacy using duration of objective response (DOR), time to response (TTR), progression free survival (PFS), and overall survival (OS).
OUTLINE:
Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1, and pembrolizumab IV over 30 minutes on day 3 of cycle 1, day 1 of subsequent cycles. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles of treatment, patients may discontinue treatment if they experience disease progression, are eligible for stem cell transplant, or if they elect to not undergo stem cell transplantation (SCT).
After completion of study treatment, patients are followed up to 5 years.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-01232 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STU00213618 | None | None | View | |
| NU 20H02 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |