Phase 4 N=128 Treatment

CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

Chronic Myelogenous Leukemia in Chronic Phase

Bottom Line

View on ClinicalTrials.gov: NCT01227577 ↗

Enrolled (actual)

128

Serious AEs

21.1%

Results posted

Feb 2016

Primary outcome: Primary: Number of Participants With Confirmed Complete Molecular Response (CMR) — 34 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nilotinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Confirmed Complete Molecular Response (CMR)	34	—
SECONDARY Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)	93; 94	—
SECONDARY Time to CMR, CCyR and MMR	NA; 5.5; 5.7	—
SECONDARY Duration of CMR, CCyR and MMR	7.97; NA; 4.86	—
SECONDARY Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)	1	—
SECONDARY Time to Progression of AP/BC	NA	—
SECONDARY Number of Participants With Loss of CCyR, MMR and CMR	6; 0; 13	—
SECONDARY Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.	—	—
SECONDARY Event-free Survival, Progression-free Survival and Overall Survival	NA; NA; NA	—

Summary

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

Eligibility Criteria

Inclusion Criteria

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

Exclusion Criteria

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with the following exception: While awaiting study start, patients may be treated with anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit), and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for frontline treatment. Patients taking a TKI prior to study entry must have at least a one day washout from their last dose of medication and have recovered from any side effects of such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01227577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.