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New hope for GVHD patients: nilotinib steps in when imatinib fails

NCT ID NCT02891395

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the drug nilotinib in 65 adults with chronic graft-versus-host disease (GVHD) who did not respond to imatinib. GVHD is a complication after a stem cell transplant where donor cells attack the patient's body. The goal was to see if nilotinib could help control the disease. Participants were followed for up to 52 weeks to measure response rates and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nilotinib
What this could lead to
If successful, nilotinib could offer a new treatment option for chronic GVHD patients who have not responded to imatinib.
What could go wrong
This is a small, early-phase trial (Phase 2) with only 65 participants. Results may not apply to all patients, and nilotinib may cause side effects or not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

65 people

The number who actually took part.

Started

Dec 2012

Finished

Jul 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: 1. ocular, oral and mucosal symptoms; 2. performance status; 3. evaluation of pulmonary functions; 4. cutaneous evaluation; 5. evaluation of musculo-skeletal manifestations; 6. 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease graft versus host disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graft versus host disease

Contacts and locations

Locations

  • CHU Besançon

    Besançon, France

  • CHU Bordeaux

    Bordeaux, France

  • CHU Clémenceau

    Caen, France

  • CHU Grenoble

    Grenoble, France

  • CHU Hotel Dieu

    Nantes, France

  • CHU Purpan

    Toulouse, France

  • CHU Sart Tilman

    Liège, Belgium

  • CHU d'Amiens

    Amiens, France

  • CHU d'Angers

    Angers, France

  • CHU de Clermont Ferrand

    Clermont-Ferrand, France

  • CHU de Lyon

    Lyon, France

  • CHU de Nice

    Nice, France

  • CHU de STRASBOURG

    Strasbourg, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre hospitalier et régional de Lille

    Lille, France

  • Diseases of Blood Service HURIEZ hospital CHRU de LILLE

    Lille, 59037, France

  • HIA de Percy

    Clamart, France

  • Hopital Morvan

    Brest, France

  • Hopital NECKER

    Paris, France

  • Hôpital Saint Eloi

    Montpellier, France

  • Hôpital pitié Salpetrière

    Paris, France

  • Institut Paoli Calmettes

    Marseille, France

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