Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host
DoubleITK
2 other identifiers
interventional
65
2 countries
22
Brief Summary
Open label non-randomized multicenter phase 2 trial with direct individual benefice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2012
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 24, 2012
CompletedFirst Submitted
Initial submission to the registry
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2017
CompletedDecember 22, 2025
July 1, 2019
4.6 years
September 1, 2016
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate at 3 months (complete and partial remission) after salvage treatment with Nilotinib in patients with chronic GVHD who failed Imatinib Mesylate (IM)
Response rate at 3 months (complete and partial remission) after salvage treatment with Nilotinib in patients with chronic GVHD who failed Imatinib Mesylate (IM)
Between Baseline and minimum 12 weeks of treatment
Secondary Outcomes (4)
Best response to IM within 12 months and the duration of this response
From 12 to 52 weeks of Imatinib Mesylate treatment
Best response rate to Nilotinib within 12 months and the duration of this response
From 12 to 52 weeks of Nilotinib treatment
use of systemic secondary treatment due to intolerance to IM
From baseline to 12 weeks of IM treatment
use of systemic secondary treatment due to intolerance to Nilotinib
From baseline to 12 weeks of Nilotinib treatment
Study Arms (1)
open-label
EXPERIMENTALInduction phase: Imatinib mesylate - starting with 100 mg/day with increase of 100 mg/day each other week up to maximum tolerable dose or 400 mg/day whichever occurred first. For the responders and in absence of toxicity, the treatment will be maintained up to one year. Salvage phase: Nilotinib - starting with 200 mg/day with increase of 200 mg/day each other week up to maximum tolerable dose or 800 mg/day whichever occurred first. In absence of toxicity, the treatment will be maintained up to one year.
Interventions
For patients under Imatinib Mesylate: the total length of follow up period for those patients will be for 52 weeks following IM treatment, with a follow up at weeks IM4, IM8, IM12, IM26, IM38 and IM52. For patients requiring a salvage phase: after the switch for nilotinib, the total length of follow up period for this phase will be for 52 weeks following nilotinib treatment, with a follow up at weeks nilo4, nilo8, nilo12, nilo26, nilo38 and nilo52.
Eligibility Criteria
You may qualify if:
- 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;
- performance status;
- evaluation of pulmonary functions;
- cutaneous evaluation;
- 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
- +8 more criteria
You may not qualify if:
- Patient developing acute GVHD (whether early or "late onset" form)
- First episode of cGVHD
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Novartiscollaborator
Study Sites (22)
CHU Sart Tilman
Liège, Belgium
CHU d'Amiens
Amiens, France
CHU d'Angers
Angers, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
Hopital Morvan
Brest, France
CHU Clémenceau
Caen, France
HIA de Percy
Clamart, France
CHU de Clermont Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
Diseases of Blood Service HURIEZ hospital CHRU de LILLE
Lille, 59037, France
Centre hospitalier et régional de Lille
Lille, France
CHU de Lyon
Lyon, France
Institut Paoli Calmettes
Marseille, France
Hôpital Saint Eloi
Montpellier, France
CHU Hotel Dieu
Nantes, France
CHU de Nice
Nice, France
Hopital NECKER
Paris, France
Hôpital pitié Salpetrière
Paris, France
Centre Henri Becquerel
Rouen, France
CHU de STRASBOURG
Strasbourg, France
CHU Purpan
Toulouse, France
Related Publications (1)
Srour M, Alsuliman T, Labreuche J, Bulabois CE, Chevallier P, Daguindau E, Forcade E, Francois S, Guillerm G, Coiteux V, Turlure P, Beguin Y, Yakoub-Agha I, Magro L. Nilotinib efficacy and safety as salvage treatment following imatinib intolerance and/or inefficacy in steroid refractory chronic graft-versus-host-disease (SR-cGVHD): a prospective, multicenter, phase II study on behalf of the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC). Bone Marrow Transplant. 2023 Apr;58(4):401-406. doi: 10.1038/s41409-022-01898-x. Epub 2023 Jan 9.
PMID: 36624161RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YAKOUB-AGHA Ibrahim, MD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2016
First Posted
September 7, 2016
Study Start
December 24, 2012
Primary Completion
July 26, 2017
Study Completion
July 26, 2017
Last Updated
December 22, 2025
Record last verified: 2019-07