NCT01043874

Brief Summary

To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_4

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 9, 2015

Completed
Last Updated

April 8, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

January 5, 2010

Results QC Date

January 14, 2015

Last Update Submit

March 10, 2016

Conditions

Philadelphia Chromosome PositiveChronic Myelogenous Leukemia in Chronic Phase

Keywords

Chronic phaseChronic myelogenous leukemiaCMLPhiladelphia chromosome positivePh+NilotinibCML-CPSuboptimal molecular response

Outcome Measures

Primary Outcomes (1)

  • MMR Rate at 12 Mos. of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Molecular Response to Imatinib at 18 Months or Later.

    MMR is defined as BCR-ABL ratio (%) on IS ≤ 0.1% (corresponds to ≥ 3 log reduction of BCR-ABL transcripts from standardized baseline value

    12 months after treatment

Secondary Outcomes (3)

  • MMR Rate at 24 Months of Nilotinib Treatment on Study in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

    24 months after treatment

  • Time to First MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .

    month 24

  • Duration of MMR of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) .

    month 24

Study Arms (1)

Nilotinib

EXPERIMENTAL

400 mg BID

Drug: Nilotinib

Interventions

NilotinibDRUG

400 mg BID

Also known as: AMN107
Nilotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients ≥ 18 years of age.
  • ECOG 0, 1, or 2.
  • Have been diagnosed with Ph+ CML-CP and receiving imatinib therapy.
  • Patients with suboptimal molecular response to imatinib treatment continued for at least 18 months (first line therapy)
  • Suboptimal molecular response defined as all of the following conditions:
  • Patients who have achieved CCyR (0% Ph+ chromosomes).
  • Patients who don't achieve MMR (MMR defined as BCR-ABL/ABL ratio of ≤ 0.1% on the International Scale as detected by RQ-PCR).
  • The treatment with imatinib defined as:
  • Dose of 300 mg or higher daily must be maintained for a minimum of 3 months prior to study entry.
  • Patients who meet the following laboratory tests criteria:
  • total bilirubin \< 1.5 x ULN,
  • SGOT and SGPT \< 2.5 x ULN,
  • creatinine \< 1.5 x ULN,
  • Serum amylase and lipase ≤ 1.5 x ULN,
  • Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
  • +2 more criteria

You may not qualify if:

  • Prior accelerated phase or blast crisis CML.
  • Previously documented T315I mutations.
  • Presence of chromosomal abnormalities other than Ph+.
  • Previous treatment with any other tyrosine kinase inhibitor except imatinib.
  • Impaired cardiac function including any one of the following:
  • Complete left bundle branch block
  • Congenital long QT syndrome or family history of long QT syndrome
  • History of or presence of significant ventricular or atrial tachyarrhythmias
  • Clinically significant resting brachycardia (\<50 bpm)
  • QTcF \> 450 msec on screening ECG
  • Use of a ventricular-paced pacemaker
  • Myocardial infarction during the last 12 months
  • Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina).
  • Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, St John's Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. See Section 6.4.3 for complete list of these medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Novartis Investigative Site

Nagoya, Aichi-ken, 453-8511, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 464-8681, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Novartis Investigative Site

Aomori, Aomori, 030-8553, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Novartis Investigative Site

Gifu, Gifu, 501-1194, Japan

Location

Novartis Investigative Site

Hiroshima, Hiroshima, 734-8551, Japan

Location

Novartis Investigative Site

Kumamoto, Kumamoto, 860-8556, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 602-8566, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 983-8520, Japan

Location

Novartis Investigative Site

Nagasaki, Nagasaki, 852-8501, Japan

Location

Novartis Investigative Site

Okayama, Okayama-ken, 700-8558, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Sayama, Osaka, 589-8511, Japan

Location

Novartis Investigative Site

Suita, Osaka, 565-0871, Japan

Location

Novartis Investigative Site

Saga, Saga-ken, 849-8501, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

Novartis Investigative Site

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Related Publications (1)

  • Miyamura K, Miyamoto T, Tanimoto M, Yamamoto K, Kimura S, Kawaguchi T, Matsumura I, Hata T, Tsurumi H, Saito S, Hino M, Tadokoro S, Meguro K, Hyodo H, Yamamoto M, Kubo K, Tsukada J, Kondo M, Aoki M, Okada H, Yanada M, Ohyashiki K, Taniwaki M. Switching to nilotinib in patients with chronic myeloid leukemia in chronic phase with molecular suboptimal response to frontline imatinib: SENSOR final results and BIM polymorphism substudy. Leuk Res. 2016 Dec;51:11-18. doi: 10.1016/j.leukres.2016.09.009. Epub 2016 Sep 5.

    PMID: 27771544DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharma K.K.

    Novartis Pharma K.K.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 7, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

April 8, 2016

Results First Posted

February 9, 2015

Record last verified: 2016-03

Locations

JP(20)