Chronic Myelogenous LeukemiaPhase 3LASORNCT00802841

Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib

A Phase 3 study testing nilotinib and imatinib in people with Chronic Myelogenous Leukemia, run by Novartis Pharmaceuticals at 56 sites in 12 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Chronic Myelogenous Leukemia
What is being tested?: nilotinib and imatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 191 participants
Where: 56 sitesin 12 countries
Study dates: May 2009to Jul 2014
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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female ≥ 18 years old;
ECOG of 0, 1, or 2;
Ph+ CML in CP defined as:
<15% blasts in peripheral blood or bone marrow;
<30% blasts + promyelocytes in peripheral blood or bone marrow;
<20% basophils in the peripheral blood;

Show all 22Show fewer

•≥100x109/L (≥ 100,000/mm3) platelets;
no evidence of extramedullary leukemia involvement, with the exception of hepatosplenomegaly;
SoR to 400 mg imatinib, defined as (min of 20 metaphases):
No cytogenetic response at ≥ 3 to <6 months (> 95% Ph+ metaphases);or
No PCyR at ≥ 6 to <12 months (36 to 95% Ph+ metaphases on bone marrow); or
No CCyR at ≥ 12 to <18 months (1 to 35% Ph+ metaphases on bone marrow); Confirmation of SoR by FISH is allowed if BMK is done outside the screening window up to 4 wks.
400mg/daily imatinib (no higher doses) for at least 3months but no longer than 18 months;
Previous use of IFN, taken prior to imatinib treatment, is allowed at a maximum of 90 days unless reason for switch from IFN to imatinib was intolerance.
Parameters must be present:
Creatinine <2.0 X ULN
Total bilirubin <1.5 X ULN (< 3.0 X ULN if related to disease);
SGOT and SGPT < 2.5 X ULN;
Serum lipase ≤1.5 X ULN;
Alkaline phosphatase ≤2.5 X ULN
Serum potassium, phosphorus, magnesium and calcium ≥ LLN or corrected to WNL with supplements prior to first dose of study drug;
Written informed consent prior to any study procedures being performed.

Who cannot join

Prior accelerated phase including clonal evolution or blast crisis CML;
Prior therapy with imatinib in combination with any other CML drug other than Hydroxyurea and/or Anagrelide;
4.Imatinib therapy started more than 12 months after the date of the original diagnosis; 5.Unable to tolerate imatinib at 400mg; 6.Previous treatment with any other tyrosine kinase inhibitor except Glivec and/or CML therapy other than IFN, hydroxyurea, and /or anagrelide; 7.Myelotoxicity ≥ Grade 2 present at the time of randomization, 8.Previously documented T315I mutations; 9.Impaired cardiac function including one of these:
Long QT syndrome or family history of long QT syndrome
Clinically significant resting brachycardia (<50 bpm)
QTcF >450 msec on screening ECG (using the QTcF formula). If QTc >450 and electrolytes are not with normal ranges, electrolytes should be corrected and then the patient rescreened for QTc to certify QTc <450 msec;
Myocardial infarction ≤ 12 months prior to the first dose of study drug;
Other clinically significant heart disease (e.g., CHF, uncontrolled hypertension, unstable angina, significant ventricular or atrial tachyarrhythmias) 10. Impairment of GI function or disease that may significantly alter the absorption of study drug; 11. Treated with strong CYP3A4 inhibitors that cannot be either discontinued or switched to a different medication prior to starting study drug; 12.Currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug; 13.History of previous acute pancreatitis within one year of study entry or medical history of chronic pancreatitis; 14.Known cytopathologically confirmed CNS 15.Women who are pregnant, breast feeding or of a childbearing potential without a negative urine pregnancy test at screening. Female patients of childbearing potential unwilling to use effective contraceptive precautions throughout the trial and for 3 months post trial end. Post-menopausal women must be ammenorrheic for at least 12 months to be considered of non-childbearing potential; 16. History of another primary malignancy that is currently clinically significant or currently requires active intervention; 17.Any other clinically significant medical or surgical condition which, according to investigators' discretion, should preclude participation; 18.Use of investigational agent within 28 days prior to enrollment; 19.Patients unwilling or unable to comply with the protocol.

Trial locations and contacts

56 sites in 12 countries.

Country

City, postcode or hospital

56 sites in 12 countries

Brazil14 sites

Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30130-100
Novartis Investigative Site
Campinas, São Paulo, 13083-970
Novartis Investigative Site
Cuiaba, Minas Gerais, 78025-000
Novartis Investigative Site
Curitiba, Paraná, 80060-900
Novartis Investigative Site
Florianópolis, Santa Catarina, 88034-000
Novartis Investigative Site
Jaú, São Paulo, 17210-080
Novartis Investigative Site
Londrina, Paraná, 86015-520
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 91350-200
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20211-030
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20230-130
Novartis Investigative Site
São Paulo, São Paulo, 01224-000
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Novartis Investigative Site
São Paulo, São Paulo, 05651-901
Novartis Investigative Site
São Paulo, São Paulo, 08270-070

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Russia10 sites

Novartis Investigative Site
Krasnoyarsk, 680022
Novartis Investigative Site
Moscow, 125167
Novartis Investigative Site
Moscow, 129110
Novartis Investigative Site
N.Novgorod, 603126
Novartis Investigative Site
Perm, 614068
Novartis Investigative Site
Rostov-on-Don, 344090
Novartis Investigative Site
Saint Petersburg, 191024
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Volgograd, 400138
Novartis Investigative Site
Yekaterinburg, 620102

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India7 sites

Novartis Investigative Site
Ahmedabad, 380016
Novartis Investigative Site
Bangalore, Karnataka, 560 095
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500018
Novartis Investigative Site
Mumbai, 400 012
Novartis Investigative Site
Mumbai 400 020, 014
Novartis Investigative Site
New Delhi, 110 029
Novartis Investigative Site
Vellore, Tamil Nadu, 632004

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China6 sites

Novartis Investigative Site
Beijing, 100044
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Fuzhou, 350001
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300020

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Mexico6 sites

Novartis Investigative Site
Mexico City, Mexico City, 02990
Novartis Investigative Site
Mexico City, Mexico City, 06720
Novartis Investigative Site
Mexico City, Mexico City, 06726
Novartis Investigative Site
Mexico City, Mexico City, 14080
Novartis Investigative Site
Monterrey, Nuevo León, 64020
Novartis Investigative Site
Zapopan, Jalisco, 45170

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Argentina4 sites

Novartis Investigative Site
Caba, Buenos Aires, C1221ADC
Novartis Investigative Site
Caba, Buenos Aires, C1426ANZ
Novartis Investigative Site
La Plata, Buenos Aires, B1900AWT
Novartis Investigative Site
Rio Negro, Viedma, 8500

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Colombia2 sites

Novartis Investigative Site
Bogota, Cundinamarca
Novartis Investigative Site
Montería

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Poland2 sites

Novartis Investigative Site
Krakow, 31-501
Novartis Investigative Site
Wroclaw, 50-367

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Venezuela2 sites

Novartis Investigative Site
Caracas, Distrito Federal, 1010
Novartis Investigative Site
Maracaibo, Zulia, 4004

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Germany1 site

Novartis Investigative Site
Berlin, 13353

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Guatemala1 site

Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010

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Panama1 site

Novartis Investigative Site
Panama City, Provincia de Panamá

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About this study

Official title: A Randomized Phase Lll Study of Imatinib Dose Optimization Compared With Nilotinib in Patients With Chronic Myelogenous Leukemia and Suboptimal Response to Standard-dose Imatinib

There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.

Read the detailed description

The comparative efficacy between imatinib dose escalation (600 mg QD) and nilotinib (400 mg BID), in terms of CCyR after 6 months, for patients with CML in chronic phase with suboptimal response to imatinib standard dose will be determined.

Conditions: Chronic Myelogenous Leukemia
Being tested: nilotinib, imatinib
Keywords: Chronic, Myelogenous, Leukemia, CML, Chronic Phase, Suboptimal Response
Medical subject headings: Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Bronchiolitis Obliterans Syndrome, Leukemia

What participants receive

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

nilotinibDrug
Also called Tasigna
Supplied as 200 mg tablets
imatinibDrug
Also called Gleevec/Glivec
Supplied as 100 mg and 400 mg tablets

Study groups in NCT00802841
Study group	Role	What they receive
Nilotinib	Experimental	Participants received 400 mg nilotinib twice daily (BID). Receives: Drug: nilotinib
Imatinib	Active comparator	Participants received 600 mg imatinib once daily (QD). Receives: Drug: imatinib

What is being measured

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

Percentage of Participants With Complete Cytogenetic Response (CCyR)
CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.
Measured: 6 months

Secondary outcomes (7)

Percentage of Participants With Major Molecular Response (MMR)
MMR was defined as having a fusion gene of the Bcr and Abl genes of (BCR-ACL) less than or equal to 0.1% on the International Scale (IS).
Measured: 12 and 24 months
Percentage of Participants With CCyr
CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.
Measured: 12 and 24 months
Time to CCyR
Time to CCyR was defined as time from date of randomization to date of first documented CCyR.
Measured: 24 months
Duration of CCyR
Duration of CCyR was defined as time from the date of ransomization to the date of first loss of CCyR or death, whichever came first.
Measured: 24 months
Progression-Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of documented disease progression to accelerated phase or blast crisis (AP/BC), or death due to any cause.
Measured: 24 months
Event-Free Survival (EFS)
EFS was defined as the time from the date of randomization to the date of the first occurrence of any of the following: loss of Complete Hematological Response (CHR), loss of Partial Cytogenetic Response (PCyR), loss of CCyR, death on treatment or progression to AP/BC.
Measured: 24 months
Overall Survival (OS)
OS was defined as time from date of randomization to the date of the death.
Measured: 24 months

Timeline

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

May 2009Jul 2014

First posted5 Dec 2008 (estimated)
Study startMay 2009
Primary completionJul 2014
Study completionJul 2014

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 Chronic 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: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00802841
Sponsor's protocol ID: CAMN107A2404
Other IDs: 2008-007054-35, 2008
Acronym: LASOR
Status last verified: Oct 2015
First submitted: 3 Dec 2008
Last updated: 16 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cortes JE, De Souza CA, Ayala M, Lopez JL, Bullorsky E, Shah S, Huang X, Babu KG, Abdulkadyrov K, de Oliveira JSR, Shen ZX, Sacha T, Bendit I, Liang Z, Owugah T, Szczudlo T, Khanna S, Fellague-Chebra R, le Coutre PD. Switching to nilotinib versus imatinib dose escalation in patients with chronic myeloid leukaemia in chronic phase with suboptimal response to imatinib (LASOR): a randomised, open-label trial. Lancet Haematol. 2016 Dec;3(12):e581-e591. doi: 10.1016/S2352-3026(16)30167-3.
PubMed 27890073

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase Lll Study of Imatinib Dose Optimization Compared With Nilotinib in Patients With Chronic Myelogenous Leukemia and Suboptimal Response to Standard-dose Imatinib
ClinicalTrials.gov ID: NCT00802841
Acronym / sponsor ID: LASOR / CAMN107A2404
Conditions: Chronic Myelogenous Leukemia
Keywords: Chronic, Myelogenous, Leukemia, CML, Chronic Phase, Suboptimal Response
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 5 Dec 2008 (estimated)
Results: Posted 16 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nilotinib	Experimental	Drug: nilotinibParticipants received 400 mg nilotinib twice daily (BID).
Imatinib	Active comparator	Drug: imatinibParticipants received 600 mg imatinib once daily (QD).

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (22 listed)

Male or female ≥ 18 years old;
ECOG of 0, 1, or 2;
Ph+ CML in CP defined as:
•≥100x109/L (≥ 100,000/mm3) platelets;
SoR to 400 mg imatinib, defined as (min of 20 metaphases):

Key exclusion criteria (8 listed)

Prior accelerated phase including clonal evolution or blast crisis CML;
Prior therapy with imatinib in combination with any other CML drug other than Hydroxyurea and/or Anagrelide;
4.Imatinib therapy started more than 12 months after the date of the original diagnosis; 5.Unable to tolerate imatinib at 400mg; 6.Previous treatment with any other tyrosine kinase inhibitor except Glivec and/or CML therapy other than IFN, hydroxyurea, and /or anagrelide; 7.Myelotoxicity ≥ Grade 2 present at the time of randomization, 8.Previously documented T315I mutations; 9.Impaired cardiac function including one of these:
Long QT syndrome or family history of long QT syndrome
Clinically significant resting brachycardia (<50 bpm)

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
nilotinibAlso: TasignaSupplied as 200 mg tablets	Drug	Nilotinib
imatinibAlso: Gleevec/GlivecSupplied as 100 mg and 400 mg tablets	Drug	Imatinib

Primary outcome

Percentage of Participants With Complete Cytogenetic Response (CCyR)
Time frame: 6 months
CCyR was assessed from bone marrow samples. CCyr was defined as having 0% Philadelphia positive (Ph+) chromosome metaphases in bone marrow.

7 secondary outcomes

Percentage of Participants With Major Molecular Response (MMR)
Time frame: 12 and 24 months
Percentage of Participants With CCyr
Time frame: 12 and 24 months
Time to CCyR
Time frame: 24 months
Duration of CCyR
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Event-Free Survival (EFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months

Results and safety

Results posted to the registry on 16 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nilotinib	96	0
Imatinib	95	0

Primary outcome: Percentage of Participants With Complete Cytogenetic Response (CCyR)

Time frame: 6 months. Number. Unit: Percentage of participants

Measure	Nilotinib n = 96	Imatinib n = 95
Value	50.0	42.1

Nilotinib vs Imatinib: p = 0.3106, Fisher Exact

Population analysed: Full Analysis Set: The FAS included all participants to whom study treatment had been assigned by randomization.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nilotinib	11 of 96 (11.5%)	80 of 96 (83.3%)	Not reported
Imatinib	9 of 93 (9.7%)	61 of 93 (65.6%)	Not reported
Cross-over to Nilotinib	4 of 56 (7.1%)	44 of 56 (78.6%)	Not reported
Cross-over to Imatinib	1 of 13 (7.7%)	11 of 13 (84.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27890073Cortes JE, De Souza CA, Ayala M, Lopez JL, Bullorsky E, Shah S, Huang X, Babu KG, Abdulkadyrov K, de Oliveira JSR, Shen ZX, Sacha T, Bendit I, Liang Z, Owugah T, Szczudlo T, Khanna S, Fellague-Chebra R, le Coutre PD. Switching to nilotinib versus imatinib dose escalation in patients with chronic myeloid leukaemia in chronic phase with suboptimal response to imatinib (LASOR): a randomised, open-label trial. Lancet Haematol. 2016 Dec;3(12):e581-e591. doi: 10.1016/S2352-3026(16)30167-3.

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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

56 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nilotinib and imatinib in people with Chronic Myelogenous Leukemia, run by Novartis Pharmaceuticals at 56 sites in 12 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 22 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: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Brazil, Russia, India, China, Mexico and 7 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 16 Nov 2015). 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?

Percentage of Participants With Complete Cytogenetic Response (CCyR) (time frame: 6 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 NCT00802841, 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 16 Nov 2015.