AzTrials
AzTrials

Graft Versus Host DiseasePhase 2DoubleITKNCT02891395

Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host

A Phase 2 study testing Imatinib Mesylate and Nilotinib in people with Graft Versus Host Disease, run by University Hospital, Lille at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Open label non-randomized multicenter phase 2 trial with direct individual benefice Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Graft Versus Host Disease
What is being tested?
Imatinib Mesylate and Nilotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
22 sitesin 2 countries
Study dates
24 Dec 2012to 26 Jul 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 23Show fewer
  • 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
  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

France21 sites

  • CHU d'Amiens

    Amiens

  • CHU d'Angers

    Angers

  • CHU Besançon

    Besançon

  • CHU Bordeaux

    Bordeaux

  • Hopital Morvan

    Brest

  • CHU Clémenceau

    Caen

  • HIA de Percy

    Clamart

  • CHU de Clermont Ferrand

    Clermont-Ferrand

  • CHU Grenoble

    Grenoble

  • Diseases of Blood Service HURIEZ hospital CHRU de LILLE

    Lille, 59037

  • Centre hospitalier et régional de Lille

    Lille

  • CHU de Lyon

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • Hôpital Saint Eloi

    Montpellier

  • CHU Hotel Dieu

    Nantes

  • CHU de Nice

    Nice

  • Hopital NECKER

    Paris

  • Hôpital pitié Salpetrière

    Paris

  • Centre Henri Becquerel

    Rouen

  • CHU de STRASBOURG

    Strasbourg

  • CHU Purpan

    Toulouse

Other trials in France

Belgium1 site

  • CHU Sart Tilman

    Liège

Other trials in Belgium

About this study

Official 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.

Open label non-randomized multicenter phase 2 trial with direct individual benefice

Read the detailed description

Induction 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. 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, will go to the salvage phase.

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.

Being tested
Imatinib Mesylate and Nilotinib
Keywords
allogeneic stem cell transplantation, imatinib Mesylate, Nilotinib
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib Mesylate and NilotinibDrug

    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.

Study groups in NCT02891395
Study groupRoleWhat they receive
open-labelExperimentalInduction 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.
Receives: Drug: Imatinib Mesylate and Nilotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Between Baseline and minimum 12 weeks of treatment

Secondary outcomes (4)

  1. Best response to IM within 12 months and the duration of this response

    Measured: From 12 to 52 weeks of Imatinib Mesylate treatment

  2. Best response rate to Nilotinib within 12 months and the duration of this response

    Measured: From 12 to 52 weeks of Nilotinib treatment

  3. use of systemic secondary treatment due to intolerance to IM

    measure intolerance by IM failure

    Measured: From baseline to 12 weeks of IM treatment

  4. use of systemic secondary treatment due to intolerance to Nilotinib

    measure intolerance by Nilotinib failure

    Measured: From baseline to 12 weeks of Nilotinib treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2016 (estimated)
  2. Study start24 Dec 2012
  3. Primary completion26 Jul 2017
  4. Study completion26 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02891395
Sponsor's protocol ID
2009_18
Other IDs
2012-000770-36
Acronym
DoubleITK
Status last verified
Jul 2019
First submitted
1 Sep 2016
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36624161

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib Mesylate and Nilotinib in people with Graft Versus Host Disease, run by University Hospital, Lille at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate at 3 months (complete and partial remission) after salvage treatment with Nilotinib in patients with chronic GVHD who failed Imatinib Mesylate (IM) (time frame: Between Baseline and minimum 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02891395, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
DoubleITK Clinical Trial NCT02891395 | AzTrials