EUCTR2012-000770-36-BE
Active, not recruiting
Phase 1
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 sites5 target enrollmentDecember 10, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic graft-versus-host disease .
- Sponsor
- CHU-ULg
- Enrollment
- 5
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •\- 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).
Outcomes
Primary Outcomes
Not specified
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