MAP to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Managed Access Program (MAP) to Provide Access to Nilotinib, for Patients With Relapsed or Refractory Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

Conditions
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Acute Lymphoblastic Leukemia (ALL)

Intervention / Treatment
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* Drug: Nilotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nilotinib|The compassionate use dose of nilotinib is 400 mg orally twice daily and should not be taken with food|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nilotinib, Acute lymphoblastic leukemia, ALL, Philadelphia chromosome positive, Ph+