Hypereosinophilic Syndrome (HES)NCT04498871
MAP to Provide Access to Nilotinib, for Patients With HES
A study testing Nilotinib in people with Hypereosinophilic Syndrome (HES), run by Novartis Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypereosinophilic Syndrome (HES)
- What is being tested?
- Nilotinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- 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
- WHO Performance status of ≤ 2
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- 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.
Who cannot join
- Patients eligible for this Treatment Plan must not meet any of the following criteria:
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as nilotinib. Any exclusionary sites of disease (e.g., brain metastases).
- Impaired cardiac function
- Patients who have undergone major surgery ≤ 2 weeks prior to Visit 1 or who have not recovered from side effects of such surgery
- Known Cytopathologically confirmed CNS infiltration.
- Use of therapeutic warfarin.
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- Acute or chronic liver or renal disease considered unrelated to tumor.
- Treatment with any hematopoietic colony-stimulating growth factors ≤ 1 week prior to starting Nilotinib. Erythropoietin is allowed.
- 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.
- Patient with a history of another primary malignancy that is currently clinically significant or requires active intervention.
- Known diagnosis of human immunodeficiency virus (HIV).
- Known ongoing alcohol or drug abuse
- Unwillingness or inability to comply with the treatment protocol including returning for scheduled visits
- Participation in a prior investigational study within 30 days prior to enrollment or within 5-half lives of the investigational product, whichever is longer.
- Pregnant or nursing (lactating) women,
About this study
Official title: Managed Access Program (MAP) to Provide Access to Nilotinib, for Patients With Hypereosinophilic Syndrome (HES)
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.
- Conditions
- Hypereosinophilic Syndrome (HES)
- Being tested
- Nilotinib
- Keywords
- Nilotinib, Hypereosinophilic syndrome, HES
- Medical subject headings
- Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
Nilotinib is recommended to be administered orally on a continuous schedule at a dose of 400 mg twice daily. The patient should be instructed to take each morning dose of nilotinib 2 hours after a light breakfast (e.g., toast and jam), with no oral intake other than water for 1 hour after dosing. It is recommended that the patient take nilotinib doses every 12 hours with a glass of water. The evening dose of nilotinib should be taken at least 2 hours after dinner with no oral intake other than water for 1 hour after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypereosinophilic Syndrome (HES)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498871
- Sponsor's protocol ID
- CAMN107A2413
- Status last verified
- Sep 2021
- First submitted
- 31 Jul 2020
- Last updated
- 20 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Program (MAP) to Provide Access to Nilotinib, for Patients With Hypereosinophilic Syndrome (HES)
- ClinicalTrials.gov ID
- NCT04498871
- Acronym / sponsor ID
- CAMN107A2413
- Conditions
- Hypereosinophilic Syndrome (HES)
- Keywords
- Nilotinib, Hypereosinophilic syndrome, HES
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- ≥ 18 years of age
- Hypereosinophilic syndrome/chronic eosinophilic leukemia who have a clinical indication for treatment and meet the following criteria (Vandenberghe, et al 2004):
- WHO Performance status of ≤ 2
- Patient must have the following laboratory values:
- Written patient informed consent must be obtained prior to start of treatment.
Key exclusion criteria (15 listed)
- History of hypersensitivity to any drugs or metabolites of similar chemical classes as nilotinib. Any exclusionary sites of disease (e.g., brain metastases).
- Impaired cardiac function
- Patients who have undergone major surgery ≤ 2 weeks prior to Visit 1 or who have not recovered from side effects of such surgery
- Known Cytopathologically confirmed CNS infiltration.
- Use of therapeutic warfarin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NilotinibNilotinib is recommended to be administered orally on a continuous schedule at a dose of 400 mg twice daily. The patient should be instructed to take each morning dose of nilotinib 2 hours after a light breakfast (e.g., toast and jam), with no oral intake other than water for 1 hour after dosing. It is recommended that the patient take nilotinib doses every 12 hours with a glass of water. The evening dose of nilotinib should be taken at least 2 hours after dinner with no oral intake other than water for 1 hour after dosing. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nilotinib in people with Hypereosinophilic Syndrome (HES), run by Novartis Pharmaceuticals.
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 17 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
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 20 Sep 2021.