Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and T… (NCT01368107) | Clinical Trial Compass
CompletedPhase 2
Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients
France24 participantsStarted 2011-06
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female aged more than 18 years
* Histologic diagnosis of metastatic breast cancer to be treated with capecitabine at study entry. NB: Patients previously treated with capecitabine are eligible only if more than 6 months have elapsed since the last capecitabine intake.
* Lymphopenic (i.e. with at least one value of lymphocyte count 1500/µL within 15 days before Day 0).
* Performance status ECOG of 0, 1,2 or 3
* Life expectancy ≥ 6months
* Adequate bone marrow, hepatic and renal function as follows:
* Neutrophils ≥ 1,000/µL
* Platelets ≥ 100 109/µL
* ASAT, ALAT, or Alkaline Phosphatase ≤ 2.5 x ULN
* Total Bilirubin ≤ 1.5 x ULN
* INR ≤ 1.5
* Calculated creatinin clearance ≥ 60mL/min (Cockcroft formula or MDRD formula for patients older than 65 years old)- Ability to understand and sign informed consent
* Covered by a medical insurance.
Exclusion Criteria:
* Prior history of other malignancies other than breast cancer (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the subjects has been free of the disease for at least 3 years.
* No resolution of specific toxicities related to any prior anti-cancer therapy to Grade ≤2 according to the NCI CTCAE v.4.0 (except lymphopenia, alopecia and neuropathy)
* Wash out period of less than 5 times the half-life of previous anti-cancer treatment before study entry, except if previous chemotherapy treatment before study entry. NB: For patient previousl…
What they're measuring
1
to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count