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Chronic Myeloid LeukemiaPhase 4ISAVNCT01578213

Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients

A Phase 4 study testing Imatinib mesylate in people with Chronic Myeloid Leukemia, run by University of Milano Bicocca at 14 sites in 5 countries.

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

The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
Imatinib mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
14 sitesin 5 countries
Study dates
9 Nov 2011to 28 Nov 2018
Phase
Phase 4
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

  • Signed and dated IRB/IEC-approved Informed Consent
  • Age>=18 years
  • Male or female patients with CML diagnosed in chronic or accelerated phase and who have been treated for more than 2 consecutive years with imatinib therapy
  • Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment
  • A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the list one performed within 3 calendar months prior to enrollment date
  • Willingness and ability to comply with scheduled visits laboratory tests and other study procedures

Who cannot join

  • Allogenic hematopoietic stem cell transplantation
  • Known active infections including human immunodeficiency virus (HIV) positivity
  • Current enrollment another clinical trial
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

Italy10 sites

  • Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele"

    Catania, Italy/Catania, 95124

  • Università di Firenze Azienda Ospedaliera - Universitaria Careggi

    Florence, Italy/Firenze, 50134

  • IRCCS A.O.U. San Martino

    Genova, 16132

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC di Ematologia

    Milan, Italy/Milano, 20162

  • Ospedale Niguarda Ca' Granda - U.O. Ematologia

    Milan, MI, 20162

  • Azienda Ospedaliera San Gerardo di Monza

    Monza, Italy/MB, 20052

  • IRCCS Policlinico San Matteo Pavia - Istituto di Ematologia

    Pavia, Italy/Pavia, 27100

  • A.O. Bianchi-Melacrino-Morelli U.O. Ematologia

    Reggio Calabria, Italy/Reggio Calabria, 89124

  • Universita di Tor Vergata Ospedale S. Eugenio

    Rome, Italy/Rome, 00142

  • Ospedale S. Bortolo (USSL 6)

    Vicenza, Italy/Vicenza, 36100

Other trials in Italy

Canada1 site

  • McGill University - Jewish General Hospital Division of Hematology and Department of Oncology

    Montreal, Quebec, H3T 1E2

Other trials in Canada

Germany1 site

  • Charité University of Berlin - Clinic of Medicine - Hematology and Oncology

    Berlin, 13353

Other trials in Germany

Israel1 site

  • Chaim Sheba Medical Center - Division of Hematology, BMT and CBB

    Tel HaShomer, 52621

Other trials in Israel

Spain1 site

  • Hospital Universitario Miguel Servet - Hematologia

    Zaragoza

Other trials in Spain

About this study

Official title: Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients (ISAV)

The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.

Read the detailed description

This study will recruit approximately 100 CML patients under imatinib therapy in complete molecular remission with a history of at least 18 months of consecutive negative standard Q-RT-PCR as performed in their own centers. After signing the informed consent form (ICF), the patients will be tested for dPCR and will discontinue imatinib therapy. Then they will be monitored by standard Q-RT-PCR to assess the maintenance of the molecular remission; collection of data will be prospective as each center will collect the data for 36 months. At the end of this period, a peripheral blood sample for dPCR analysis will be obtained from those patients who will still have undetectable BCR-ABL transcripts by Q-RT-PCR to verify CML eradication. The maintenance of molecular remission by Q-RT-PCR and the survival will be monitored every six months during an additional follow-up of 24 months. Patients found to be positive to BCR-ABL transcripts by standard Q-RTPCR will repeat the test every 2 to 4 weeks until the loss of molecular remission, defined as two consecutive BCR-ABL positive tests with at least one with BCR-ABL/BCR value above 0.1%, or until the end of the study, whichever come first.

Being tested
Imatinib mesylate
Medical subject headings
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.

  • Imatinib mesylateDrug

    Also called Glivec, Gleevec

    • Capsules, hard 50 or 100 mg/Film-coated Tablets 100 or 400 mg
    • Total dosage per day: 800 mg
    • Oral use
Study groups in NCT01578213
Study groupRoleWhat they receive
ImatinibExperimentalNot described
Receives: Drug: Imatinib mesylate

What is being measured

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

  1. The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR

    The capability of the dPCR method to predict relapse-free patients relative to the standard method. NPV of each method will be computed as the number of patients who are negative according to either method at the time of imatinib discontinuation and remain relapse-free 36 months later over the total of negative patients according to either method, respectively

    Measured: At 36 months.

Secondary outcomes (8)

  1. Rate of molecular and cytogenetic relapse

    Rate of molecular and cytogenetic relapse after discontinuation of imatinib treatment out of total number of patients enrolled

    Measured: At 36 months

  2. Rate of dPCR positive patients

    Rate of patients who are dPCR positive before discontinuation of imatinib and who do not relapse within the following 36 months (false positive) out of the total number of relapse-free patients at month 36.

    Measured: At 36 months

  3. Rate of dPCR negative patients

    Rate of patients who are dPCR negative before discontinuation of imatinib and who relapse (false negative) out of the total number of patients relapsing within the following 36 months.

    Measured: At 36 months

  4. Rate of patients who are maintaining dPCR negativity for 36 months

    Rate of patients who are maintaining dPCR negativity for 36 months over the patients who are Q-RT-PCR negative at the end of the interval.

    Measured: At 36 months

  5. Time to molecular relapse

    Time to molecular relapse, both from the first PCR-negative and from the discontinuation of imatinib to the time of loss of molecular response, respectively.

    Measured: At 36 months

  6. Overall Survival

    Overall Survival

    Measured: At the end of the study

  7. Quality of Life Assessment

    Quality of Life, as measured by the Global Health Status\QOL and other subscales scores of EORTC-QLQ-C30 questionnaire

    Measured: At 36 months

  8. Rate of patients progressing or developing resistance

    Rate of patients progressing or developing resistance after imatinib resumption out of total number of patients enrolled

    Measured: At 36 months

Timeline

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

  1. First posted16 Apr 2012 (estimated)
  2. Study start9 Nov 2011
  3. Primary completion28 Nov 2018
  4. Study completion28 Nov 2018

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01578213
Sponsor's protocol ID
ISAV
Other IDs
2011-002749-37
Acronym
ISAV
Status last verified
Nov 2019
First submitted
13 Apr 2012
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Imatinib mesylate in people with Chronic Myeloid Leukemia, run by University of Milano Bicocca at 14 sites in 5 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 6 inclusion and 4 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 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy, Canada, Germany, Israel, Spain. 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?

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?

The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR (time frame: At 36 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 NCT01578213.

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 3 Dec 2019.

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