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Status:

COMPLETED

Phase I/II for Safety and Efficacy of Nilotinib in a Population Steroid-refractory/or Steroid-dependent cGVHD

Lead Sponsor:

Gruppo Italiano Trapianto di Midollo Osseo

Conditions:

Chronic Graft Versus Host Disease

Eligibility:

All Genders

18-64 years

Phase:

PHASE1

Brief Summary

Chronic Graft versus Host Disease (cGvHD) has been identified as the leading cause of late non-relapse mortality in Hemopoietic Stem Cell Transplant (HSCT) survivors. Up to now a standard satisfactory...

Detailed Description

Chronic Graft versus Host Disease (cGvHD) has been identified as the leading cause of late non-relapse mortality in Hemopoietic Stem Cell Transplant (HSCT) survivors. Up to now a standard satisfactory...

Eligibility Criteria

Inclusion

  • Written informed consent
  • Male
  • not pregnant female
  • patients \>=18 and \<65 years old
  • Weight \>40 Kg
  • Fertile female must use both anti-conception devices and oral contraceptives
  • Diagnosis of cGVHD steroid refractory (no response after Prednisone ≥1mg/kg along 6-8 weeks) or steroid-dependent cGVHD (need of \> 0.4 mg/Kg/die of Prednisone continuously)
  • Patient intolerant to steroid therapy
  • Patients with extensive cGVHD including one of the following features:
  • skin sclerosis in more than 50% body surface area; active disease with significant progression in the last 6 months or
  • skin sclerosis in less than 50% BSA, but presence of visceral involvement or
  • Lung cGVHD involvement, documented by Histology (when possible) and/or High Resolution computed tomography scan plus significant alterations of Respiratory tests: forced vital capacity or diffusion capacity deterioration in the last 12 months; Forced expiratory volume in one second \<75% predicted ratio within 1 year; evidence of air-trapping or small-airway thickening or bronchiectasis on High-resolution computed tomography or pathologic confirmation of constrictive bronchiolitis; no evidence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, including radiologic studies or microbiologic cultures. A quantitative lung involvement by cGVHD should be made by using the modified Lung Functional Score\* (LFS).
  • Visceral sclerosis clinically relevant with digestive involvement also without skin involvement; biopsy at physician discretion.
  • In all patient with skin involvement the cGVHD should by documented by Histology
  • Patients with visceral involvement clinically and technically documented, but without skin sclerosis will be included if the clinical diagnosis of cGVHD is conformed to NIH criteria
  • LFS calculated according to NIH consensus project on criteria for clinical trials in cGVHD
  • Failure of at least two immunosuppressive lines, including the steroids
  • Lab criteria:
  • Alanine aminotransferase and aspartate aminotransferase \<2.5 x Upper Limit of Normal or \>5.0 x Upper Limit of Normal if considered due to the disease Alkaline phosphatase \<2.5 x Upper Limit of Normal
  • Serum bilirubin \<1.5 x Upper Limit of Normal
  • Serum creatinine \<1.5 x Upper Limit of Normal
  • Serum amylase \<1.5 x Upper Limit of Normal and serum lipase \<1.5 x Upper Limit of Normal
  • Normal serum level of potassium, total calcium corrected for serum albumin; magnesium and phosphorus
  • Absolute neutrophil count≥1000/mmc
  • Platelets ≥50,000 mmc

Exclusion

  • Patients with stable disease, well controlled by the current treatment
  • Patients who do not need high-dose steroids (daily dose of prednisone \<0.4 mg/kg/day) and/or other immunosuppressive agents
  • Pregnancy, fertile female without intention to use contraceptives or breast feeding
  • Previous treatment with Imatinib or Rituximab in the last six months
  • Severe liver or renal impairment: serum creatinine \>2,5 mg/dl; serum bilirubin\>2,5 mg/dl (without evidence of hepatic cGVHD)
  • Other uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation.
  • Any other investigational agents administered within last four weeks
  • History of myocardial infarction within the last 12 months
  • Uncontrolled angina pectoris
  • Cardiac insufficiency (\>grade II, New York Heart Association classification)
  • Arrhythmia
  • Long QT syndrome and/or corrected QT interval \>450 msec on screening ECG
  • History of acute or chronic pancreatitis
  • Use of therapeutic coumarin derivates
  • Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
  • Use of all strong CYP3A4 inhibitors is excluded.

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2016

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT01810718

Start Date

November 1 2011

End Date

March 1 2016

Last Update

March 10 2023

Active Locations (12)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (12 locations)

1

Chaim Sheba Medical Center

Tel Litwinsky, Israel

2

Ematologia e Centro Trapianti Midollo Osseo - Ospedale IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy, 71013

3

Clinica di Ematologia - Ospedali Riuniti di Ancona

Ancona, Italy

4

S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle

Cuneo, Italy