Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426764
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2007-01-23
Brief Title:
A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase II Multicenter Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin Depsipeptide FK228 In Progressive Or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy GPI-06-0002
Status:
COMPLETED
Status Verified Date:
2020-01
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:
The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma PTCL who have already been treated with systemic therapy
Detailed Description:
This is a Phase II non-randomized open-label single-arm trial This study is designed on the basis of complete response CR or unconfirmed CR CRu as the measure of efficacy based on the best overall response of each patient The sample size of 65 patients evaluable for efficacy would yield lower 95 confidence limits on the rate of CR CRu that would range from 22 to 77 if the observed rate of CR CRu ranges from 8 to 15 The study was amended to include an Extension Phase during which patients at non-US sites who are benefitting from treatment can continue to receive romidepsin The Extension Study Phase is active in EU countries where currently no Marketing Authorisation exists for romidepsin Patients may remain on study until progressive disease occurs or they withdraw their consent and only serious adverse events and study drug administration data will continue to be collected and reported for these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-006228-21 | EUDRACT_NUMBER | None | None |