Open label non-randomized multicenter phase 2 trial with direct individual benefice
Drug: Imatinib Mesylate and Nilotinib
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Full eligibility criteria for NCT02891395
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Induction phase (IM):
Patients aged ≥18 years to 75 years
Patients who underwent allo-SCT for a hematological disorder
Body weight ≥ 40 Kg.
Confirmed diagnosis of cGVHD resistant to at least one systemic immunosuppressive therapy. The diagnosis of cGHVD should be based on the NIH Working Group Consensus
(www.asbmt.org/gvhd/index.htm). Grading of cGVHD will be based on clinical manifestations including:
ocular, oral and mucosal symptoms;
evaluation of pulmonary functions;
evaluation of musculo-skeletal manifestations;
evaluation of liver involvement;
Any source of hematopoietic stem cell is allowed
Both myeloablative and nonmyeloablative conditioning regimens are authorized.
Absence of contra-indications to the use of IM or Nilotinib
Patient having French health care coverage
Female patients of childbearing potential must have before initiation of study drug and agree to have efficient contraceptive precautions throughout the trial and for 3 months after the end of the trial.
Signed informed consent. Salvage phase (Nilotinib) : Patients enrolled in the first phase and who failed to IM:
Patients, who discontinue imatinib mesylate at 3 months for lack of response (no response = stable disease),
those who experience progression at any time,
those who relapse after an initial response at any time
or those who discontinue for toxicity at any time.
Patient developing acute GVHD (whether early or "late onset" form)
First episode of cGVHD
Patient who received IM or Nilotinib treatment or any other TKI after transplant 3 months before the inclusion on the study
Patient treated by TKI for a GVHD
Contra-indication to IM or Nilotinib
Neutropenia < 0.5 G/L
Uncontrolled systemic infection which can be associated, according to the investigator, to an enhanced risk of patient's death during the first month of treatment
Severe neurological or psychiatric disorders
Pregnancy or lactation
Known uncontrolled arrhythmias or symptomatic heart disease or left ventricular ejection fraction < 40% (cardiac tests as clinically indicated)
Recurrence of cancer for which the transplant was done except for presence of minimal residual disease by PCR
Patients with secondary malignancy ≤ 2 years prior study-entry except:
Basal cell carcinoma of the skin
Squamous cell carcinoma of the skin
Carcinoma in situ of the cervix
Carcinoma in situ of the breast
Prostate cancer (Tumor, Node, Metastasis [TNM] stage T1a or T1b)
Patients in emergency situation
Patients kept in detention
Patients unable or unwilling to comply with the protocol requirements
All locations for NCT02891395
CHU Sart Tilman
HIA de Percy
CHU de Clermont Ferrand
Clermont Ferrand, France
Diseases of Blood Service HURIEZ hospital CHRU de LILLE
LIlle, France, 59037
Centre hospitalier et régional de Lille
CHU de Lyon
Institut Paoli Calmettes
Hôpital Saint Eloi
CHU Hotel Dieu
CHU de Nice
Hôpital pitié Salpetrière
Centre Henri Becquerel
CHU de STRASBOURG
View full eligibility
Tris trial is registered with FDA with number: NCT02891395. The sponsor of the trial is University Hospital, Lille and it is looking for 65 volunteers for the current phase.
Official trial title: Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host (Graft Versus Host, GVH) Did Not Respond to Imatinib Mesylate.
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