Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106431
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2005-03-24
Brief Title:
A Single Agent Phase II Study of Romidepsin Depsipeptide FK228 in the Treatment of Cutaneous T-cell Lymphoma CTCL
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Single Agent Phase II Study of Depsipeptide FK228 in the Treatment of Cutaneous T-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2019-10
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:
None
Brief Summary:
GPI-04-0001 was a Phase II non-randomized open label single arm study that was conducted at approximately 30 sites primarily in the United States Europe and Russia It assessed the efficacy safety and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma CTCL Study patients pts received romidepsin in a dose of 14 mgm2 intravenously over 4 hours on Days 1 8 and 15 of each 28-day cycle The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy at the discretion of the investigator until disease progression or another withdrawal criterion was met
Detailed Description:
Responses were evaluated according to a composite assessment Objective Primary Disease Response Evaluation Criteria OPDREC that included cutaneous manifestations of disease lymph node involvement and circulating malignant T-cells Sézary cells Skin involvement was measured using a weighted body surface area skin assessment tool WBSASWAT or an erythroderma score depending upon the pts disease Disease response was assessed by the Investigators and an Independent Response Review Committee IRRC with the IRRC assessment considered supportive of the Investigators evaluations using the following criteria
Complete Response CR
Complete resolution of skin patches skin plaques and skin tumors or erythroderma
No evidence of abnormal lymph nodes
Absence of circulating Sézary cells
No evidence of new tumors cutaneous or non-cutaneous
Findings confirmed by skin biopsy
Clinical complete response CCR
- Same as CR but without skin biopsy
Partial Response PR
50 improvement in the summation of change in Skin change in Lymph Node change in Peripheral Blood with
At least 30 improvement in Skin and
No worsening in Lymph Node or Sézary cells
No evidence of new tumors cutaneousnon-cutaneous
Stable Disease SD
Not enough improvement or worsening in the summation of change in Skin change in Lymph Node change in Peripheral Blood to qualify as PR or PD
No evidence of new tumors cutaneousnon-cutaneous
SD90
- SD90 was defined as documented evidence of SD for at least 90 Days Duration
Progressive Disease PD
Evidence of new tumor cutaneous or non-cutaneous OR
25 worsening in the summation of change in Skin change in Lymph Node change in Peripheral Blood with 15 worsening in change in Skin
Complete Response CR
Complete resolution of skin patches skin plaques and skin tumors or erythroderma
No evidence of abnormal lymph nodes
Absence of circulating Sézary cells
No evidence of new tumors cutaneous or non-cutaneous
Findings confirmed by skin biopsy
Clinical complete response CCR
- Same as CR but without skin biopsy
Partial Response PR
50 improvement in the summation of change in Skin change in Lymph Node change in Peripheral Blood with
At least 30 improvement in Skin and
No worsening in Lymph Node or Sézary cells
No evidence of new tumors cutaneousnon-cutaneous
Stable Disease SD
Not enough improvement or worsening in the summation of change in Skin change in Lymph Node change in Peripheral Blood to qualify as PR or PD
No evidence of new tumors cutaneousnon-cutaneous
SD90
- SD90 was defined as documented evidence of SD for at least 90 Days Duration
Progressive Disease PD
Evidence of new tumor cutaneous or non-cutaneous OR
25 worsening in the summation of change in Skin change in Lymph Node change in Peripheral Blood with 15 worsening in change in Skin
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