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

Acute Lymphoblastic Leukemia (ALL) Clinical Trial

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)

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT04559555
• Other study ID #: CAMN107A2412
• Status: No longer available

Study information

• Verified date: May 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical 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).

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Male or Female patients age = 18 years

2. WHO Performance Status of 0, 1 or 2

3. Relapsed or refractory Ph+ ALL

4. Imatinib (or dasatinib) must be discontinued at least 5 days prior to beginning therapy

5. 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia (ALL)
• Leukemia
• Leukemia, Lymphoid
• Philadelphia Chromosome
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals