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Leukemia, Myeloid, Chronic-PhasePhase 2NCT01856283

Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells

A Phase 2 study testing Nilotinib 300mg BID in people with Leukemia, Myeloid, Chronic-Phase, run by Niguarda Hospital at 17 sites in Italy.

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 multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM during nilotinib treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Chronic-Phase
What is being tested?
Nilotinib 300mg BID
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
17 sitesItaly
Study dates
Mar 2013to Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Ph chromosome (9;22) translocation within 3 months of diagnosis
  • Patients Ph negative or with variant translocations by standard cytogenetic analysis but Ph positive by FISH, are eligible as well
  • Age ≥ 18 years old (no upper age limit given)
  • WHO performance status ≤2
  • Normal serum levels ≥ LLN (lower limit of normal) of potassium, magnesium, total calcium corrected for serum albumin or phosphorus, or correctable to within normal limits with supplements, prior to the first dose of study medication
  • AST and ALT ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to leukaemia
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  • Alkaline phosphatase ≤ 2.5 x ULN unless considered due to leukaemia
  • Total bilirubin ≤ 1.5 x ULN, except know Mb Gilbert
  • Serum lipase and amylase ≤ 1.5 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Written informed consent signed prior to any study procedures being performed

Who cannot join

  • Pre-treatment with HU for > 3 months and with imatinib is not permitted
  • Prior accelerated phase including clonal evolution or blast crisis
  • Contraindication to excipients in study medication
  • impaired cardiac function including any of the following:
  • LVEF <45%
  • Complete left bundle branch block
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  • Right bundle branch block plus left anterior hemiblock,bifascicular block
  • Use of a ventricular-paced pacemaker
  • Congenital long QT syndrome
  • Clinically significant ventricular or atrial tachyarrhythmias
  • Clinically significant resting bradycardia (<50 beats per minute)
  • QTcF >450 msec on screening ECG.If QTcF >450 msec and electrolytes are not within normal ranges before nilotinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF criterion
  • Myocardial infarction within 12 months prior to starting nilotinib
  • Other clinical significant heart disease (e.g. unstable angina,congestive heart failure,uncontrolled hypertension)
  • Acute (i.e. within 1 year of starting study medication) or chronic pancreatitis
  • Concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infections,acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g.ulcerative disease,uncontrolled nausea,vomiting and diarrhea,malabsorption syndrome,small bowel resection or gastric by-pass surgery)
  • Concomitant medications with potential QT prolongation (see link for complete list: http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm)
  • Concomitant medications known to be strong inducers or inhibitors of the CYP450 Isoenzyme CYP3A4:see link for complete list (http://medicine.iupui.edu/flockhart/table.htm)
  • Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Patients who are pregnant or breast feeding or women of reproductive potential not employing an effective method of birth control.Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to administration of nilotinib.Post menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential.Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
  • Treatment with any haematopoietic colony-stimulating growth factors (e.g. G-CSF, GM-CSF) ≤1 week prior to starting study drug
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Patients unwilling or unable to comply with the protocol

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Italy17 sites

  • Ospedali Riuniti Bergamo

    Bergamo

  • Spedali Civili Brescia

    Brescia

  • A.O di Circolo di Busto Arsizio

    Busto Arsizio, Varese

  • Ospedale Valduce

    Como

  • Istituti Ospitalieri di Cremona

    Cremona

  • A.O. Ospedale S. Antonio

    Gallarate, Milano

  • A.O Ospedale Lecco

    Lecco

  • Ospedale San Raffaele

    Milan, Italy

  • A.O Sacco

    Milan

  • Istituto dei Tumori

    Milan

  • Istituto Europeo Oncologia

    Milan

  • Ospedale Maggiore Policlinico

    Milan

  • Ospedale S. Paolo

    Milan

  • S. Gerardo di Monza

    Monza

  • Policlinico S.Matteo Pavia

    Pavia

  • A.O. Universitaria Fondazione Macchi

    Varese

  • Ospedale Desio- "Ospedale Civile" di Vimercate, Desio, Carate Brianza, Giussano, Seregno.

    Vimercate, Milano

Other trials in Italy

About this study

Official title: An Open Label, Single Arm, Phase II Study of Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients, in Order to Verify Disappearance of CD34+/Lin-Ph+ Cells From Bone Marrow During Treatment

This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM during nilotinib treatment.

In addition, in this study the investigators aim to perform Gene Expression Profiling (GEP) of CML enrolled patients using Affymetrix GeneChip Instruments and Software Systems, and Affymetrix GeneChip Human Genome U133 Plus 2.0 (whole human transcriptome analysis) at diagnosis and at 3 different time points during treatment with Nilotinib (after 3, 6, 12 months).

Read the detailed description

This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM during nilotinib treatment.

The primary efficacy endpoint is to measure the rate of CD34+/lin-Ph+ cells in the BM after 6 months of treatment. In order to obtain this result, BM blood of all enrolled patients will be stored after 6 months of treatment with nilotinib. The isolated CD34+/lin- cells will be employed for standard FISH analysis. These endpoints will be obtained at the central laboratory of Niguarda Ca' Granda Hospital, Milano, Italy.

Secondary endpoints will be reached performing:

  • the same analyzes on CD34+/lin- cells at diagnosis, at 3 and 12 months of treatment;
  • cytogenetic analysis to estimate the rate of CCyR at 3, 6 and 12 months; this analysis will be performed at each local laboratory;
  • molecular analysis to determinate the rate of MR (≤ 10%, ≤ 1%, MMR, MR4,5 IS) at 3, 6 and 12 months in the peripheral blood; the molecular analysis will be performed using the Labnet standardized laboratories in Lombardy.
Being tested
Nilotinib 300mg BID
Medical subject headings
Leukemia, Myeloid, Chronic-Phase

What participants receive

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

  • Nilotinib 300mg BIDDrug

    Also called Nilotinib

    Nilotinib

Study groups in NCT01856283
Study groupRoleWhat they receive
NilotinibExperimentalstudy of nilotinib 300 mg BID
Receives: Drug: Nilotinib 300mg BID

What is being measured

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

  1. CD34+/lin-Ph+ cells

    To measure the rate of CD34+/lin-Ph+ cells in the BM after 6 months of treatment. In order to obtain this result, BM blood of all enrolled patients (see Appendix

    1. will be stored after 6 months of treatment with nilotinib. The isolated CD34+/lin- cells will be employed for standard FISH analysis.

    Measured: 6 month

Secondary outcomes (1)

  1. CD34+/lin- cells (composite measure)

    Secondary endpoints will be reached performing:

    • the same analyzes on CD34+/lin- cells at diagnosis, at 3 and 12 months of treatment;
    • cytogenetic analysis to estimate the rate of CCyR at 3, 6 and 12 months; this analysis will be performed at each local laboratory; molecular analysis to determinate the rate of MR (≤ 10%, ≤ 1%, MMR, MR4,5 IS) at 3, 6 and 12 months in the peripheral blood; the molecular analysis will be performed using the Labnet standardized laboratories in Lombardy.

    The Outcome Measure indicates that the measure is a composite.

    Measured: 12 month

Timeline

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

  1. First posted17 May 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionJul 2020
  4. Study completionJan 2021

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
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01856283
Sponsor's protocol ID
PhilosoPhy34 CAMN107EIT11T
Status last verified
Jan 2021
First submitted
14 May 2013
Last updated
13 Jan 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nilotinib 300mg BID in people with Leukemia, Myeloid, Chronic-Phase, run by Niguarda Hospital at 17 sites in Italy.

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 11 inclusion and 25 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

CD34+/lin-Ph+ cells (time frame: 6 month). 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 NCT01856283.

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 13 Jan 2021.

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