Ignite Creation Date:
2024-05-05 @ 11:36 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01368107
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2011-06-06
Brief Title:
Study Evaluating Impact of IL-7 on CD4 Lymphopenia Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
A Randomised Multicentric Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2013-12
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 the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients
The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count
This study is a phase II randomised double-blind placebo-controlled single-centre
24 patients will be included in the study
The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count
This study is a phase II randomised double-blind placebo-controlled single-centre
24 patients will be included in the study
Detailed Description:
A key secondary objective is to determine if CYT107 treatment enables to reduce the incidence of severe haematological toxicity any type of haematological toxicity Grade 3 post-chemotherapy
Other secondary objectives are to assess the impact of CYT107 treatment on the following parameters
Overall incidence of side effects any type any grade
Progression-free survival PFS
Compliance to chemotherapy regimen dose intensity number of chemotherapy cycles
CD4 lymphopenia over the study period
Exploratory biological markers
A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will
selectively stimulate the proliferation and activation of peripheral immune subsets analysis of phenotype and activation status of peripheral immune e sub-populations
selectively improve the functional response of T cells DC subsets and NK cells
is able to revert tolerogenic immune burden to increase specific anti-tumor response measure of antigen specific CD8 response measure of cytokine plasmatic levels
enable to increase TCR diversity analysis of combinatorial diversity
Other secondary objectives are to assess the impact of CYT107 treatment on the following parameters
Overall incidence of side effects any type any grade
Progression-free survival PFS
Compliance to chemotherapy regimen dose intensity number of chemotherapy cycles
CD4 lymphopenia over the study period
Exploratory biological markers
A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will
selectively stimulate the proliferation and activation of peripheral immune subsets analysis of phenotype and activation status of peripheral immune e sub-populations
selectively improve the functional response of T cells DC subsets and NK cells
is able to revert tolerogenic immune burden to increase specific anti-tumor response measure of antigen specific CD8 response measure of cytokine plasmatic levels
enable to increase TCR diversity analysis of combinatorial diversity
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 |
|---|---|---|---|
| 2011-000226-30 | EUDRACT_NUMBER | None | None |