Myelogenous LeukemiaPhase 3ENESTNCT00519090
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
A Phase 3 study testing Imatinib and Nilotinib (AMN107) in people with Myelogenous Leukemia, run by Novartis Pharmaceuticals at 80 sites in 10 countries.
Trial summary
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelogenous Leukemia
- What is being tested?
- Imatinib and Nilotinib (AMN107)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 80 sitesin 10 countries
- Study dates
- Oct 2007to Oct 2008
- Phase
- Phase 3
- 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
- Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.
- Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:
- 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
- 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).
Who cannot join
- Patient who have received more than 18 months of imatinib therapy
- Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
- Prior treatment with greater than 400 mg/day imatinib.
- Uncontrolled or significant cardiovascular disease.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- Currently taking certain medications that could affect the rhythm of your heart.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
80 sites in 10 countries.
80 sites in 10 countries
United States36 sites
Southern California Permanente Medical Group
Anaheim, California, 92801
University of Michigan
Ann Arbor, Michigan, 48103
Southern California Permanente Medical Group
Baldwin Park, California, 91706
Johns Hopkins Hospital
Baltimore, Maryland, 21201
Indiana Blood and Marrow Transplantation
Beech Grove, Indiana, 46107
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015
Northwestern Memorial Hospital
Chicago, Illinois, 60601
The University of Chicago Medical Center
Chicago, Illinois, 60601
Rocky Mountain Cancer Center
Denver, Colorado, 80201
Duke University Hospital
Durham, North Carolina, 27701
Southern California Permanente Medical Group
Fontana, California, 92334
Jones Cancer Center
Germantown, Tennessee, 38138
Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49501
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Kaiser Permanente Medical Group/Hayward Medical Center
Hayward, California, 94540
University of Texas/MD Anderson Cancer Center
Houston, Texas, 77001
Holden Cancer Center
Iowa City, Iowa, 52240
Southern California Permanente Medical Group
Los Angeles, California, 90001
Vanderbilt University
Nashville, Tennessee, 37201
Kaiser Permanente Medical Group/Oakland Medical Center
Oakland, California, 94601
Methodist Cancer Center
Omaha, Nebraska, 68101
Southern California Permanente Medical Group
Panorama City, California, 91402
Oregon Health Sciences University
Portland, Oregon, 97201
Southern California Permanente Medical Group
Riverside, California, 92501
Kaiser Permanente Medical Group/Sacramento Medical Center
Sacramento, California, 94203
Southern California Permanente Medical Group
San Diego, California, 92101
Kaiser Permanente Medical Group
San Francisco, California, 94101
Kaiser Permanente Medical Group
San Jose, California, 95101
Kaiser Permanente Medical Group/Santa Clara Medical Office
Santa Clara, California, 95050
Swedish Cancer Institute
Seattle, Washington, 98101
Kaiser Permanente Medical Group/South San Francisco Medical Center
South San Francisco, California, 94101
Arizona Cancer Center
Tucson, Arizona, 85701
Kaiser Permanente Medical Group/Vallejo Medical Center
Vallejo, California, 94589
Kaiser Permanente Medical Group/Walnut Creek Medical Center
Walnut Creek, California, 94595
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101
Southen California Permanente Medical Group
Woodland Hills, California, 91364
Germany13 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Düsseldorf
Novartis Investigative Site
Eisensach
Novartis Investigative Site
Firenze
Novartis Investigative Site
Greifswald
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Jena
Novartis Investigative Site
Kiel
Novartis Investigative Site
Leipzeg
Novartis Investigative Site
Postsdam
Novartis Investigative Site
Rostock
Novartis Investigative Site
Stuttgart
Novartis Investigative Site
Weiden
Australia7 sites
Novartis Investigative Site
Darlinghurst
Novartis Investigative Site
Herston
Novartis Investigative Site
Liverpool
Novartis Investigative Site
Perth
Novartis Investigative Site
Prahran
Novartis Investigative Site
South Brisbane
Novartis Investigative Site
St Leonards
Italy6 sites
Novartis Investigative Site
Bologna
Novartis Investigative Site
Milan
Novartis Investigative Site
Naples
Novartis Investigative Site
Orbassano
Novartis Investigative Site
Reggio Calabra
Novartis Investigative Site
Roma
Spain5 sites
Novartis Investigative Site
Barcelona
Novartis Investigative Site
Madrid
Novartis Investigative Site
Salamanca
Novartis Investigative Site
Santiago de Compostela
Novartis Investigative Site
Valencia
Belgium3 sites
Novartis Investigative Site
Bruges
Novartis Investigative Site
Ghent
Novartis Investigative Site
Leuven
Brazil3 sites
Novartis Investigative Site
Mannheim
Novartis Investigative Site
Porto Alegre
Novartis Investigative Site
São Paulo
Japan3 sites
Novartis Investigative Site
Nagoya
Novartis Investigative Site
Oaska
Novartis Investigative Site
Tokyo
Czechia2 sites
Novartis Investigative Site
Olomouc
Novartis Investigative Site
Prague
South Korea2 sites
Novartis Investigative Site
Hwasun-Gun
Novartis Investigative Site
Seoul
About this study
Official title: A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Read the detailed description
This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to < 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to < 18 months and having partial cytogenetic response (PCyR), but no CCyR.
- Conditions
- Myelogenous Leukemia
- Being tested
- Imatinib, Nilotinib (AMN107)
- Keywords
- leukemia, bone marrow, leukemia symptoms, cml, complete blood count, lymphocyte, blood cancer, leukocytes, chronic leukemia, bone marrow biopsy, leukemia research, leukemia cells, bone marrow disease, chronic myeloid leukemia, blood cancer symptoms, white blood cell diseases, chronic myelogenous leukemia, leukemia treatment, leukemia facts, leucemia
- Medical subject headings
- Leukemia, Myeloid, Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hematologic Neoplasms, Bone Marrow Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called STI571, imatinib mesylate, Glivec®, Gleevec®
Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.
Nilotinib (AMN107)Drug
Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Nilotinib (AMN107) | Experimental | Not described Receives: Drug: Nilotinib (AMN107) |
| Imatinib | Active comparator | Not described Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Measured: 12 months
Secondary outcomes (1)
Durable Complete Cytogenetic Response Rate
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: This study was terminated due to limited enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519090
- Sponsor's protocol ID
- CAMN107A2302
- Acronym
- ENEST
- Status last verified
- Nov 2011
- First submitted
- 17 Aug 2007
- Last updated
- 7 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Agrawal M, Hanfstein B, Erben P, Wolf D, Ernst T, Fabarius A, Saussele S, Purkayastha D, Woodman RC, Hofmann WK, Hehlmann R, Hochhaus A, Muller MC. MDR1 expression predicts outcome of Ph+ chronic phase CML patients on second-line nilotinib therapy after imatinib failure. Leukemia. 2014 Jul;28(7):1478-85. doi: 10.1038/leu.2014.6. Epub 2014 Jan 10.
PubMed 24472814
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib
- ClinicalTrials.gov ID
- NCT00519090
- Acronym / sponsor ID
- ENEST / CAMN107A2302
- Conditions
- Myelogenous Leukemia
- Keywords
- leukemia, bone marrow, leukemia symptoms, cml, complete blood count, lymphocyte, blood cancer, leukocytes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to limited enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Posted 10 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Detailed description
This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to < 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to < 18 months and having partial cytogenetic response (PCyR), but no CCyR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nilotinib (AMN107) | Experimental | Drug: Nilotinib (AMN107) |
| Imatinib | Active comparator | Drug: Imatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.
- Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:
- 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
- 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).
Key exclusion criteria (8 listed)
- Patient who have received more than 18 months of imatinib therapy
- Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
- Prior treatment with greater than 400 mg/day imatinib.
- Uncontrolled or significant cardiovascular disease.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImatinibAlso: STI571, imatinib mesylate, Glivec®, Gleevec®Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days. | Drug | Imatinib |
| Nilotinib (AMN107)Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days. | Drug | Nilotinib (AMN107) |
Primary outcome
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib
Time frame: 12 months
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
1 secondary outcome
Durable Complete Cytogenetic Response Rate
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24472814Agrawal M, Hanfstein B, Erben P, Wolf D, Ernst T, Fabarius A, Saussele S, Purkayastha D, Woodman RC, Hofmann WK, Hehlmann R, Hochhaus A, Muller MC. MDR1 expression predicts outcome of Ph+ chronic phase CML patients on second-line nilotinib therapy after imatinib failure. Leukemia. 2014 Jul;28(7):1478-85. doi: 10.1038/leu.2014.6. Epub 2014 Jan 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
80 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imatinib and Nilotinib (AMN107) in people with Myelogenous Leukemia, run by Novartis Pharmaceuticals at 80 sites in 10 countries.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Germany, Australia, Italy, Spain and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 May 2011). 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?
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib (time frame: 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 NCT00519090, 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 7 Nov 2011.