Acute Lymphoblastic Leukemia (ALL)NCT04559555
MAP to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
A study testing Nilotinib in people with Acute Lymphoblastic Leukemia (ALL), run by Novartis Pharmaceuticals.
Trial summary
The purpose of this Cohort Treatment Plan is to allow access to nilotinib for eligible patients diagnosed with relapsed or refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL)
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following criteria must be fulfilled for the provision of Managed Access and will vary depending on the stage of the product lifecycle:
- An independent request should be received from the Treating Physician (in some instances from Health Authorities, Institutions or Governments);
- The patient to be treated has a serious or life threatening disease or condition, and no comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition;
- The patient is not eligible or able to enroll in a clinical trial;
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated;
- Provision of the investigational product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program and
- Such access provision as described above is allowed as per local laws and regulations.
Who cannot join
- Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
- Male or Female patients age ≥ 18 years
- WHO Performance Status of 0, 1 or 2
- Relapsed or refractory Ph+ ALL
- Imatinib (or dasatinib) must be discontinued at least 5 days prior to beginning therapy
- Normal organ, electrolyte and marrow functions as described below:
Show all 15Show fewer
- Absolute Neutrophil Count (ANC) ≥ 1.0 x 1000000000/L
- Platelets 50 x 1000000000/L
- Potassium ≥ LLN (Lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of nilotinib
- Total calcium (corrected for serum albumin) ≥ LLN
- Magnesium ≥ LLN or corrected to within normal limits with supplements prior to the first dose of nilotinib medication
- AST and ALT ≤ 2.5 x ULN or ≤ 5.0 x UL:N if considered due to tumor
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum bilirubin ≤ 1.5 x ULN
- Serum amylase and lipase ≤ 1.5 x ULN
About this study
Official title: Managed Access Program (MAP) to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
The purpose of this Cohort Treatment Plan is to allow access to nilotinib for eligible patients diagnosed with relapsed or refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
Read the detailed description
Currently, preliminary responses of nilotinib monotherapy in adults with refractory or relapsed Ph+ ALL show limited clinical benefit in this population of patients with a high unmet medical need. Remissions induced by imatinib are of short duration and resistance to imatinib represents a major clinical challenge. The exact benefit and role of nilotinib in this leukemia remains to be determined and requires further analysis. Until further data is available patients with Ph+ ALL should be treated with nilotinib through the Individual Patient Program.. Studies to date indicate that nilotinib may provide clinical benefit to Ph+ ALL patients and may represent a novel treatment option for these patients.
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Being tested
- Nilotinib
- Keywords
- Nilotinib, Acute lymphoblastic leukemia, ALL, Philadelphia chromosome positive, Ph+
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
The compassionate use dose of nilotinib is 400 mg orally twice daily and should not be taken with food
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia (ALL)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
- NCT04559555
- Sponsor's protocol ID
- CAMN107A2412
- Status last verified
- May 2022
- First submitted
- 16 Sep 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. 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 Relapsed or Refractory Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)
- ClinicalTrials.gov ID
- NCT04559555
- Acronym / sponsor ID
- CAMN107A2412
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Keywords
- Nilotinib, Acute lymphoblastic leukemia, ALL, Philadelphia chromosome positive, Ph+
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 23 Sep 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 Cohort Treatment Plan is to allow access to nilotinib for eligible patients diagnosed with relapsed or refractory Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).
Detailed description
Currently, preliminary responses of nilotinib monotherapy in adults with refractory or relapsed Ph+ ALL show limited clinical benefit in this population of patients with a high unmet medical need. Remissions induced by imatinib are of short duration and resistance to imatinib represents a major clinical challenge. The exact benefit and role of nilotinib in this leukemia remains to be determined and requires further analysis. Until further data is available patients with Ph+ ALL should be treated with nilotinib through the Individual Patient Program.. Studies to date indicate that nilotinib may provide clinical benefit to Ph+ ALL patients and may represent a novel treatment option for these patients.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The following criteria must be fulfilled for the provision of Managed Access and will vary depending on the stage of the product lifecycle:
- An independent request should be received from the Treating Physician (in some instances from Health Authorities, Institutions or Governments);
- The patient to be treated has a serious or life threatening disease or condition, and no comparable or satisfactory alternative therapy is available to monitor or treat the disease or condition;
- The patient is not eligible or able to enroll in a clinical trial;
- There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated;
Key exclusion criteria (15 listed)
- Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:
- Male or Female patients age ≥ 18 years
- WHO Performance Status of 0, 1 or 2
- Relapsed or refractory Ph+ ALL
- Imatinib (or dasatinib) must be discontinued at least 5 days prior to beginning therapy
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 |
|---|---|---|
| NilotinibThe compassionate use dose of nilotinib is 400 mg orally twice daily and should not be taken with food | 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 9 Aug 2022.
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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 Acute Lymphoblastic Leukemia (ALL), 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 7 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 9 Aug 2022. 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 9 Aug 2022.