CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
placebo +3 moredrug
Likely dose
interleukin 7 10µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01368107
NCT01368107Phase 2Completed
CompareCT.gov

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

Centre Leon Berard·interventional·Posted Jun 7, 2011·Updated Feb 9, 2015

In Brief

A Phase 2 clinical trial evaluating placebo and interleukin 7 for Metastatic Breast Cancer. Completed, enrolled 24 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesFrance
CollaboratorsMinistry of Health, France, Cytheris, Inc.

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2011
Enrollment StartJun 1, 2011
Primary CompletionSep 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.1 years ago

Interventions

placebodrug

Placebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)

interleukin 7drug

patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and the placebo during the 3rd CT cycle (D57, D64, D71)

interleukin 7drug

patients will receive the placebo before the 1st CT cycle (D0, D7, D14) and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)

interleukin 7drug

patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)