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Chronic Myelogenous Leukemia - Chronic PhasePhase 2MACS0254NCT00644878

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

A Phase 2 study testing Nilotinib in people with Chronic Myelogenous Leukemia - Chronic Phase, run by Novartis Pharmaceuticals at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nilotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
11 sitesUnited States
Study dates
Oct 2008to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Select Inclusion Criteria:

  • Male or female patients ≥ 18 years of age with a confirmed diagnosis of Ph+ CML-CP and CCyR
  • A suboptimal molecular response to imatinib defined as:
  • Group 1: Treated with 1 year of imatinib, complete cytogenetic response (CCyR) but no major molecular response (MMR) (Bcr-Abl levels >0.1%IS);
  • Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log increase in Bcr-Abl transcript levels
  • Adequate end organ function
  • Patients must have had an imatinib washout period of at least 3 days and not to exceed 7 days prior to the first dose of nilotinib. Group 1 patients must have been treated with imatinib for at least 1 year. There was no imatinib treatment duration requirement for Group 2 patients.
  • For Group 1, patients were eligible for screening if they were treated with an imatinib dose of at least 400mg daily. Dose reduction could have occurred as long as the minimum dose was 300mg daily and the reduction lasted ≤ 28 days. The patient was required to be on 400 mg daily (or a higher dose) of imatinib for at least 6 consecutive months leading up to screening for this study.
  • For Group 2 patients, dose reduction while on imatinib could have occurred as long as the minimum dose was 300 mg daily, and the reduction lasted ≤28 days.

Select Exclusion Criteria:

  • Prior accelerated phase or blast crisis CML
  • Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to entering study
  • Previously documented T315I mutations
  • Prior therapy with any other tyrosine kinase inhibitor except imatinib
  • Patients with contraindications to receiving nilotinib, including concomitant medications

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Georgia Health Sciences University Dept. of MCG

    Augusta, Georgia, 30912

  • St. Agnes Hospital

    Baltimore, Maryland, 21229

  • Indiana Blood and Marrow Institute

    Beech Grove, Indiana, 46107

  • South Texas Institute of Cancer

    Corpus Christi, Texas, 78405

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29615

  • Baylor College of Medicine - Breast Care Dan L Duncan Cancer Ctr

    Houston, Texas, 77030

  • University of Iowa Hospitals & Clinics Univ of Iowa Hosp & Clinic

    Iowa City, Iowa, 52242

  • USC Norris Cancer Center Jane Anne Nohl

    Los Angeles, California, 90033

  • Froedert Memorial Lutheran Hospital Dept.ofFroedert Memorial

    Milwaukee, Wisconsin, 53226

  • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center

    New Orleans, Louisiana, 70115

  • Central Utah Clinic Central Utah Clinic (7)

    Provo, Utah, 84604

Other trials in United States

About this study

Official title: A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

Being tested
Nilotinib
Keywords
leukemia, chronic myelogenous leukemia, chronic phase, molecular response, nilotinib, ENABL
Medical subject headings
Leukemia, Myeloid, Chronic-Phase, Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NilotinibDrug

    Also called Tasigna, AMN 107

    Nilotinib 300 mg is taken by mouth twice a day at 12 hour intervals. Nilotinib is to be taken with water on an empty stomach. No food two hours prior to the dose of nilotinib and for one hour following the dose.

Study groups in NCT00644878
Study groupRoleWhat they receive
NilotinibExperimentalNot described
Receives: Drug: Nilotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels

    The change on a logarithmic scale at 12 months from a standardized baseline value (100% on the international scale [IS]) in Bcr-Abl transcripts as assessed by peripheral blood Quantitative real-time polymerase chain reaction (RQ-PCR).

    Measured: From Baseline up to 12 Months

Secondary outcomes (7)

  1. Number of Participants Who Achieved Major Molecular Response (MMR)

    Major Molecular Response (MMR) value at molecular MD is designated a percentage, which is equivalent to a 3-log reduction from a standardized baseline value from the International Randomized InteYesrferon versus STI571 (IRIS) study or 0.1 percent (%) per International Scale (IS).

    Measured: From Baseline up to 12 Months

  2. Number of Participants Achieved Reduction From a Standardized Baseline Value in Bcr-Abl Transcript Levels up to Month 12

    Number of participants experiencing either a greater than or equal to (>or=) 1, >or= 2, or >or= 3 log10 reduction in Bcr-Abl transcript levels from Baseline to End of Cycle (EOC) 45 (Day1219 - Day1302) were presented.

    Measured: From Baseline up to 12 Months

  3. Median Time to Best Molecular Response

    The median time to best molecular response, defined as the time (in months) from the date of enrollment to the date when the maximum reduction in Bcr-Abl transcript level was observed.

    Measured: From Start of Study up to End of the Study (up to 41 Months)

  4. Duration of Best Molecular Response

    Duration of best molecular response, defined as the time (in months) from the date of best molecular response to a date when an increase in >1 log10 was observed

    Measured: From Start of Study up to End of the Study (up to 41 Months)

  5. Number of Participants With an Event-free Survival

    Event-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of any of the following: loss of complete hematological response (CHR), loss of Complete cytogenetic response (CCyR), >1 log increase in Bcr-Abl transcripts from the lowest recorded value, progression to accelerated or blast phase, and death.

    Measured: From Start of Study up to End of the Study (up to 41 Months)

  6. Number of Participants With a Progression-free Survival

    Progression-free survival was defined as the number of participants from the date of enrollment to the date of first occurrence of progression to Accelerated phase (AP) or Blast crisis (BC) phase, chronic myelogenous leukemia (CML) or death. Participants who did not have an event or dropped out without an event are considered censored at the date of the last observed event.

    Measured: From Start of Study up to End of the Study (up to 41 Months)

  7. Number of Participants With an Overall Survival

    Overall survival was defined as the number of participants from enrollment to the date of death.

    Measured: From Start of Study Enrollment up to End of the Study (up to 41 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMar 2012
  4. Study completionMar 2012

Why it stopped: Slower than expected enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00644878
Sponsor's protocol ID
CAMN107AUS09
Acronym
MACS0254
Status last verified
Jul 2021
First submitted
19 Mar 2008
Last updated
18 Aug 2021
Data monitoring committee
No

Publications

  • Ailawadhi S, Akard LP, Miller CB, Jillella A, DeAngelo DJ, Ericson SG, Lin F, Warsi G, Radich J. Exploratory study on the impact of switching to nilotinib in 18 patients with chronic myeloid leukemia in chronic phase with suboptimal response to imatinib. Ther Adv Hematol. 2017 Jan;8(1):3-12. doi: 10.1177/2040620716678118. Epub 2016 Nov 24.

    PubMed 28042454

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nilotinib in people with Chronic Myelogenous Leukemia - Chronic Phase, run by Novartis Pharmaceuticals at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Log Change From Baseline in Breakpoint Cluster Region Gene (BCR) - Abelson Proto-oncogene (ABL) (Bcr-Abl) Transcript Levels (time frame: From Baseline up to 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00644878, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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