MAP to Provide Access to Nilotinib, for Patients With HES

Related Clinical Trial
MAP to Provide Access to Nilotinib, for Patients With HES Eosinophilia Diagnosis A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622 This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With Hypereosinophilic Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression Phase II Gleevec Idiopathic Hypereosinophilic Syndrome Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES) Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome Steroid Treatment for Hypereosinophilic Syndrome Natural History of Hypereosinophilia and Hypereosinophilic Syndromes A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome Identification of New Markers in the Hypereosinophilic Syndrome A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome

Brief Title

MAP to Provide Access to Nilotinib, for Patients With HES

Official Title

Managed Access Program (MAP) to Provide Access to Nilotinib, for Patients With Hypereosinophilic Syndrome (HES)

Brief Summary

      The purpose of this program is to allow access to nilotinib for eligible patients diagnosed
      with Hypereosinophilic syndrome (HES). The patient's Treating Physician should follow the
      suggested treatment guidelines and comply with all local health authority regulations. The
      requesting Treating Physician submitted a request for access to drug (often referred to as
      Compassionate Use) to Novartis which was reviewed and approved by the medical team
      experienced with the drug and indication. Please refer to the latest Investigator's Brochure
      (IB) or approved label for overview of drug including: non-clinical and clinical experience,
      risk and benefits. Novartis will continue to provide any new safety information to the
      Treating Physician as they emerge.
    



Study Type

Expanded Access




Condition

Hypereosinophilic Syndrome (HES)

Intervention

Nilotinib


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug





Eligibility Criteria

        Inclusion criteria

          1. ≥ 18 years of age

          2. Hypereosinophilic syndrome/chronic eosinophilic leukemia who have a clinical
             indication for treatment and meet the following criteria (Vandenberghe, et al 2004):

               -  eosinophilia greater than 1500/mm3 which persists greater than 6 months

               -  exclusion of other causes of eosinophilia including clonal or abnormal T-cell
                  populations, exclusion of reactive eosinophilia, and malignancies or T-cell
                  disorders associated with eosinophilia

               -  signs and symptoms of organ involvement

          3. WHO Performance status of ≤ 2

          4. Patient must have the following laboratory values:

               -  Potassium ≥ LLN (lower limit of normal) or corrected to within normal limits with
                  supplements prior to the first dose of AMN107

               -  Total calcium (corrected for serum albumin) ≥ LLN or correctable with supplements

               -  Magnesium ≥ LLN or corrected to within normal limits with supplements prior to
                  the first dose of AMN107

               -  Phosphorus ≥ LLN or correctable with supplements

               -  ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor

               -  Alkaline phosphatase ≤ 2.5 x ULN unless considered due to tumor

               -  Serum bilirubin ≤ 1.5 x ULN

               -  Serum creatinine ≤ 1.5 x ULN

               -  Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULNWritten patient informed
                  consent must be obtained prior to start of treatment.

        Written patient informed consent must be obtained prior to start of treatment.

        Exclusion criteria

        Patients eligible for this Treatment Plan must not meet any of the following criteria:

          1. History of hypersensitivity to any drugs or metabolites of similar chemical classes as
             nilotinib. Any exclusionary sites of disease (e.g., brain metastases).

          2. Impaired cardiac function

          3. Patients who have undergone major surgery ≤ 2 weeks prior to Visit 1 or who have not
             recovered from side effects of such surgery

          4. Known Cytopathologically confirmed CNS infiltration.

          5. Use of therapeutic warfarin.

          6. Acute or chronic liver or renal disease considered unrelated to tumor.

          7. Treatment with any hematopoietic colony-stimulating growth factors ≤ 1 week prior to
             starting Nilotinib. Erythropoietin is allowed.

          8. Patient who has not recovered from side effects of prior chemotherapy, immunotherapy,
             other investigational drugs, wide field radiotherapy, or major surgery. Patient who
             has received imatinib < 5 days prior to AMN107 or has not recovered from side effects
             of therapy. Hydroxyurea is permitted during the first 28 days of treatment (up to 5
             g/day) for a maximum of 7 days.

          9. Patient with a history of another primary malignancy that is currently clinically
             significant or requires active intervention.

         10. Known diagnosis of human immunodeficiency virus (HIV).

         11. Known ongoing alcohol or drug abuse

         12. Unwillingness or inability to comply with the treatment protocol including returning
             for scheduled visits

         13. Participation in a prior investigational study within 30 days prior to enrollment or
             within 5-half lives of the investigational product, whichever is longer.

         14. Pregnant or nursing (lactating) women,
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, +41613241111, [email protected]



Administrative Informations


NCT ID

NCT04498871

Organization ID

CAMN107A2413


Responsible Party

Sponsor

Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

, , 


Verification Date

June 2020