Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

Launched by UNIVERSITY HOSPITAL, ROUEN · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a medication called eculizumab is for treating a condition known as thrombotic microangiopathy (TMA), which can occur after receiving a chemotherapy drug called gemcitabine. The study aims to understand how patients with TMA respond to eculizumab, a treatment that helps reduce harmful blood clotting and inflammation.

To be eligible for this trial, participants must be at least 18 years old, have received gemcitabine treatment within the last 18 months, and have certain medical conditions related to TMA, including signs of kidney issues. The trial is open to all genders and will include patients who are either in remission from cancer or have a life expectancy of more than six months. If you join the study, you'll receive eculizumab and be monitored by healthcare professionals throughout the treatment. It's important to note that there are specific criteria that may exclude some individuals from participating, such as ongoing severe infections or certain health conditions. This trial is not yet recruiting participants, but it aims to gather valuable information that could help improve treatment options for patients with TMA in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old 2. Previous treatment with gemcitabine within the last 18 months (duration of treatment ≥ 3 consecutive months and cumulative dose should be ≥ 10 grams). 3. Neoplasia in remission or not in remission but with an estimated life expectancy \> 6 months 4. Acute renal failure defined by 1 of the following 2 criteria : Creatinine \> 2 times baseline creatinine and/or diuresis \< 0.5 ml/kg/h for 12 hours. 5. Clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tThrombocytopeniaPatient affiliated with a social security system, 6. Adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form. 7. Woman of childbearing age with effective contraception as defined by the WHO (estrogen-progestin or intrauterine device or tubal ligation) for more than one month and a negative -HCG pregnancy test at baseline, for the duration of the study and for at least 5 months after the end of the treatment, or Postmenopausal woman (non-medically induced amenorrhea for at least 12 months prior to the baseline visit) or For men, use of protection during sexual intercourse for the duration of the study and for at least 60 days after the end of study treatment
• Exclusion Criteria:
• • 1. Progressive neoplasia with a life expectancy of \<6 months 2. Patient with a contraindication to the administration of the treatment experienced: SOLIRIS® 300 mg concentrate for solution for infusion 3. Contraindication to antibiotic prophylaxis 4. Thrombotic microangiopathy associated with cancer (metastatic adenocarcinoma with bone marrow invasion, erythromyelemia, disseminated intravascular coagulation) 5. Active systemic bacterial infection, untreated or confirmed sepsis (positive blood cultures within 7 days of patient inclusion and not treated with effective antibiotic therapy) 6. Unresolved meningococcal infection 7. Patient not vaccinated against meningococcal infection 8. Pregnant or breastfeeding woman or proven lack of contraception 9. Known systemic lupus erythematosus 10. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship 11. Patient participating in another interventional clinical trial / having participated in another interventional clinical trial within 1 month