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

NCT04559555 | Unknown

• 1 other identifier: CAMN107A2412
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Acute Lymphoblastic Leukemia (ALL)

Keywords

Nilotinib; Acute lymphoblastic leukemia; ALL; Philadelphia chromosome positive; Ph+

Interventions

Nilotinib DRUG

The compassionate use dose of nilotinib is 400 mg orally twice daily and should not be taken with food

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 23, 2020
• Last Updated: August 9, 2022

Record last verified: 2022-05