Studies
| Study First Submitted Date | 2020-09-16 |
| Study First Posted Date | 2020-09-23 |
| Last Update Posted Date | 2022-08-09 |
| Verification Month Year | May 2022 |
| Verification Date | 2022-05-31 |
| Last Update Posted Date | 2022-08-09 |
Detailed Descriptions
| Sequence: | 20832024 |
| 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
| Sequence: | 52454314 |
| Name | Acute Lymphoblastic Leukemia (ALL) |
| Downcase Name | acute lymphoblastic leukemia (all) |
Id Information
| Sequence: | 40361231 |
| Id Source | org_study_id |
| Id Value | CAMN107A2412 |
Interventions
| Sequence: | 52764407 |
| Intervention Type | Drug |
| Name | Nilotinib |
| Description | The compassionate use dose of nilotinib is 400 mg orally twice daily and should not be taken with food |
Keywords
| Sequence: | 80252941 | Sequence: | 80252937 | Sequence: | 80252938 | Sequence: | 80252939 | Sequence: | 80252940 |
| Name | Ph+ | Name | Nilotinib | Name | Acute lymphoblastic leukemia | Name | ALL | Name | Philadelphia chromosome positive |
| Downcase Name | ph+ | Downcase Name | nilotinib | Downcase Name | acute lymphoblastic leukemia | Downcase Name | all | Downcase Name | philadelphia chromosome positive |
Browse Conditions
| Sequence: | 194567971 | Sequence: | 194567972 | Sequence: | 194567973 | Sequence: | 194567974 | Sequence: | 194567975 | Sequence: | 194567976 | Sequence: | 194567977 | Sequence: | 194567978 | Sequence: | 194567979 | Sequence: | 194567980 | Sequence: | 194567981 | Sequence: | 194567982 | Sequence: | 194567983 |
| Mesh Term | Leukemia | Mesh Term | Precursor Cell Lymphoblastic Leukemia-Lymphoma | Mesh Term | Leukemia, Lymphoid | Mesh Term | Philadelphia Chromosome | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases | Mesh Term | Translocation, Genetic | Mesh Term | Chromosome Aberrations | Mesh Term | Pathologic Processes |
| Downcase Mesh Term | leukemia | Downcase Mesh Term | precursor cell lymphoblastic leukemia-lymphoma | Downcase Mesh Term | leukemia, lymphoid | Downcase Mesh Term | philadelphia chromosome | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases | Downcase Mesh Term | translocation, genetic | Downcase Mesh Term | chromosome aberrations | Downcase Mesh Term | pathologic processes |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48582299 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Novartis Pharmaceuticals |
Eligibilities
| Sequence: | 30927884 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254204375 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
Responsible Parties
| Sequence: | 29040262 |
| Responsible Party Type | Sponsor |