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Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Myeloid Leukemia

Intervention: Nilotinib, interferon-alfa (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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).

Clinical Details

Official title: An Open Label, Nonrandomized, Single-center, Phase I Trial of Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP) With Nilotinib in Combination With Low Dose Interferon-alpha (IFN) - NICOLI Study -

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

Primary outcome: 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

Secondary outcome:

Rate of major cytogenetic response (MCyR) at 6 and 12 months

Rate of complete cytogenetic response (CCyR) at 6 and 12 months

Rate of major molecular response (MMR) at 12 months

Safety profile of nilotinib in combination with interferon alfa, i.e. the number of dose limiting toxicities (DLT) for each interferon alfa dose level

Progression-free survival (PFS)

Event-free survival

Overall survival (OS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Novartis Investigative Site, Leipzig 04103, Germany
Additional Information

Related publications:

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.

Starting date: April 2012
Last updated: May 1, 2015

Page last updated: August 23, 2015

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