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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01220648
Other study ID # CAMN107ADE10
Secondary ID 2010-022006-40
Status Completed
Phase Phase 1
First received October 6, 2010
Last updated May 1, 2015
Start date April 2012
Est. completion date January 2014

Study information

Verified date May 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with chronic myeloid leukemia in chronic phase (CML-CP) at screening

- Initial diagnosis of CML cytogenetically confirmed by the presence of the Ph+ metaphases from the bone marrow

- Patients who have been treated with nilotinib for a minimum of 6 months (1 month represents 28 days) after switch from previous CML treatments

- Patients who have been treated with stable dosing of 2x400mg nilotinib within the last month before start of study treatment

- No grade 3-4 CTC toxicities on nilotinib alone in the last month preceding the start of the study regimen

Exclusion Criteria:

- Patients who are considered Ph- because they do not have a confirmed cytogenetic diagnosis of the t(9;22) translocation in their bone marrow metaphases

- Evidence of a point mutation within the BCR-ABL gene leading to a clinically relevant amino acid exchange in the kinase domain at position T315 (gatekeeper mutation T315I)

- Impaired cardiac function

- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Nilotinib, interferon-alfa


Locations

Country Name City State
Germany Novartis Investigative Site Leipzig

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Guilhot F, Roy L, Saulnier PJ, Guilhot J. Interferon in chronic myeloid leukaemia: past and future. Best Pract Res Clin Haematol. 2009 Sep;22(3):315-29. doi: 10.1016/j.beha.2009.10.005. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Clinically significant adverse events or abnormal laboratory values (dose-limiting toxicities) unrelated to disease progression, intercurrent illness, or concomitant medications on the combination treatment 12 months Yes
Secondary Rate of major cytogenetic response (MCyR) at 6 and 12 months 12 months No
Secondary Rate of complete cytogenetic response (CCyR) at 6 and 12 months 12 months No
Secondary Rate of major molecular response (MMR) at 12 months 12 months No
Secondary Safety profile of nilotinib in combination with interferon alfa, i.e. the number of dose limiting toxicities (DLT) for each interferon alfa dose level 12 months Yes
Secondary Progression-free survival (PFS) 12 months Yes
Secondary Event-free survival 12 months Yes
Secondary Overall survival (OS) 12 months Yes
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