Efficacy and tolerance of nilotinib in patients with chronic graft-versus-host disease who did not respond to imatinib mesylate. - Double ITK-GVHc

CHU-ULg0 个研究点目标入组 5 人开始时间: 2013年12月10日最近更新: 2021年1月18日

适应症

试验速览

暂无简介。

•Induction phase (imatinib)
•- Age: = 18 and <75 years.
•- Patients who underwent allogeneic hematopoietic stem cell transplantation for a hematological disease.
•- Body weight = 40 kg.
•- Confirmed diagnosis of an extensive cGVH resistant to at least one systemic immunosuppressive therapy.
•- Any source of hematopoietic stem cells is authorized.
•- Myeloablative and non-myeloablative regimes are allowed.
•- No contra-indication to the use of IM or nilotinib.
•Salvage Phase (nilotinib):
•Patients enrolled in the first phase who did not respond to IM:
•- Patients who discontinued IM after 3 months du to a lack of response.
•(stable disease = no response)
•- Patients who experienced disease progression at any time.
•- Patients who relapsed after an initial response at any time.
•- Patients who discontinued treatment due to toxicity at any time.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

•- Appearance of acute GVHD ( early form or late onset ).
•- First episode of cGVHD or cGVHD not requiring systemic treatment.
•- Patient treated with IM or nilotinib , a tyrosine kinase inhibitor given after transplantation within 3 months before enrollment.
•- Patients treated with ITK for GVHD.
•- Contra-indication to IM or nilotinib.
•- Neutropenia < 0,5.10E9 / l.
•- Uncontrolled systemic infection which the investigator may associate to an increased death risk during the first month of treatment .
•- Severe neurological or psychiatric disorders .
•- Pregnant or breastfeeding women .
•- Known uncontrolled arrhythmias or symptomatic heart disease or ventricular ejection fraction < 45% (cardiac tests according to clinical indication).
•- Performance index: WHO = 3 unrelated to chronic GVHD.
•- Relapse of the blood disease for which transplantation was performed except presence of minimal residual disease confirmed by PCR.
•- Appearance of a secondary cancer = 2 years before enrollment, subject to the following exceptions :
•-cutaneous basal cell carcinoma.
•-squamous cell carcinoma of skin.
•-carcinoma in situ of the cervix.
•-carcinoma in situ of the breast.
•-prostate cancer (Stage TNM [ Tumor , Node , Metastasis ] T1a or T1b) .
•- Refusal to sign the consent form .
•- Patients in an emergency situation or unable to consent .

发起方

CHU-ULg