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Chronic Myelogenous Leukemia in Chronic PhasePhase 4MACS1428NCT01227577

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

A Phase 4 study testing Nilotinib in people with Chronic Myelogenous Leukemia in Chronic Phase, run by Novartis Pharmaceuticals at 32 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). 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
128 participants
Where
32 sitesUnited States
Study dates
Nov 2010to Nov 2014
Phase
Phase 4
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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • Georgia Regents University MedCollege of GA Cancer Ctr 2

    Augusta, Georgia, 30912

  • University of Maryland

    Baltimore, Maryland, 21201

  • Indiana Blood and Marrow Institute

    Beach Grove, Indiana, 46107

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer

    Burbank, California, 91505-6866

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

    Chattanooga, Tennessee, 37404

  • Stroger Cook County Hospital Division of Hematology & Onc

    Chicago, Illinois, 60612

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Bay Area Cancer Research Dept.ofBayAreaCancerResearch

    Concord, California, 94520

  • Baylor Research Institute Baylor Research Institute (17)

    Dallas, Texas, 75204

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center Duke University Med Ctr

    Durham, North Carolina, 27710

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Cancer Centers of the Carolinas Cancer Center

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.

    Hackensack, New Jersey, 07601

  • Oncology Consultants Oncology Consultants, P.A.

    Houston, Texas, 77024

  • Millennium Oncology

    Houston, Texas, 77090

  • Sarah Cannon Research Institute SCRI

    Jacksonville, Florida, 32256

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Tennessee Oncology Sarah Cannon Research Inst.

    Nashville, Tennessee, 37203

  • LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)

    New Orleans, Louisiana, 70115

  • Pasco Hernando Oncology

    New Port Richey, Florida, 34652

  • University of Nebraska Medical Center University of Nebraska Med Ctr

    Omaha, Nebraska, 68198

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • University of Rochester Medical Ct James P Wilmot Cancer Ctr

    Rochester, New York, 14642

  • St. Louis University Cancer Center

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Cancer Center of Kansas

    Witchita, Kansas, 67214-3728

  • St. Jude Heritage Medical Group Virginia Crosson Cancer Center

    Yorba Linda, California, 92886

Other trials in United States

About this study

Official title: 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)

"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."

Being tested
Nilotinib
Keywords
CML, Chronic Myelogenous Leukemia, Leukemia, CML-CP, Nilotinib
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia

What participants receive

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

  • NilotinibDrug

    Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Study groups in NCT01227577
Study groupRoleWhat they receive
NilotinibExperimentalParticipants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
Receives: Drug: Nilotinib

What is being measured

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

  1. Number of Participants With Confirmed Complete Molecular Response (CMR)

    CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.

    Measured: 4 years

Secondary outcomes (8)

  1. Number of Participants With Complete Cytogenetic Response (CCyR) and Major Molecular Response (MMR)

    CCyR was defined as 0% Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow. MMR was defined as a 3 log reduction of Bcr-Abl transcripts from the standardized baseline on the international scale (equivalent to Bcr-Abl ≤ 0.1% IS).

    Bcr-Abl transcripts assessed by peripheral blood quatitative real time polymerase chain reaction (RQ-PCR) were used for the determination of all molecular responses.

    Measured: 4 years

  2. Time to CMR, CCyR and MMR

    Time to CMR, CCyR, and MMR was defined as the time from the date of enrollment to the date of first documented CMR, CCyR and MMR, respectively.

    Measured: 4 years

  3. Duration of CMR, CCyR and MMR

    Duration of CMR, CCyR and MMR were defined as the time from the first date of achievement of the response to the date of first documented loss of the response.

    Measured: 4 years

  4. Number of Participants With Progression to Accelerated Phase/Blastic Crisis (AP/BC)

    Progression to AP/BC is defined as loss of CCyR, MMR, and CMR and was summarized by frequencies and percentages.

    Measured: 4 years

  5. Time to Progression of AP/BC

    Time to progression of AP/BC was defined as the time from the date of the first dose of study drug to the date of first documented progression of AP/BC.

    Measured: 4 years

  6. Number of Participants With Loss of CCyR, MMR and CMR

    Rate of loss of CMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.0032% IS. Rate of loss of CCyR was defined as an increase in the Ph+ bone marrow cells to greater than 0%. Rate of loss of MMR was defined as an increase in the Bcr-Abl transcripts to greater than 0.1% IS.

    Measured: 4 years

  7. Number of Participants With CMR Who Were Dosed to 400 mg b.i.d.

    CMR was defined as at least 4.5 log reduction of breakpoint cluster region gene/Abelson proto-oncogene (Bcr-Abl) transcipts from the standardized baseline on the international scale (equivalent to Bcr-Abl <=0.0032% IS) with a minimum of 25,614 ABL control copies. CMR was to be confirmed by a second polymerase chain reaction (PCR) sample drawn 3 months later where the results should be less than or equal to 0.0032% with a minimum of 25,614 Abelson proto-oncogene (ABL) control copies.

    Measured: 4 years

  8. Event-free Survival, Progression-free Survival and Overall Survival

    Event-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of CCyR, loss of Partial Cytogenetic Response (PCyR), progression to the accelerated phase or blast crisis, and death from any cause. Progression-free survival was defined as the time from the date of enrollment to the date of first occurrence of any of the following: progression to the accelerated phase or blast crisis, death, and loss of CMR. Overall survival was defined as the time from the date of enrollment until death due to any cause.

    Measured: 4 years

Timeline

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

  1. First posted25 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionNov 2014
  4. Study completionNov 2014

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01227577
Sponsor's protocol ID
CAMN107AUS28
Acronym
MACS1428
Status last verified
Jan 2016
First submitted
21 Oct 2010
Last updated
8 Feb 2016
Data monitoring committee
No

Publications

  • Berdeja JG, Heinrich MC, Dakhil SR, Goldberg SL, Wadleigh M, Kuriakose P, Cortes J, Radich J, Helton B, Rizzieri D, Paley C, Dautaj I, Mauro MJ. Rates of deep molecular response by digital and conventional PCR with frontline nilotinib in newly diagnosed chronic myeloid leukemia: a landmark analysis. Leuk Lymphoma. 2019 Oct;60(10):2384-2393. doi: 10.1080/10428194.2019.1590569. Epub 2019 Mar 26.

    PubMed 30912699

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nilotinib in people with Chronic Myelogenous Leukemia in Chronic Phase, run by Novartis Pharmaceuticals at 32 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?

The sponsor lists 1 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 8 Feb 2016). 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?

Number of Participants With Confirmed Complete Molecular Response (CMR) (time frame: 4 years). 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 NCT01227577, 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 8 Feb 2016.

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