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Chronic Myelogenous Leukemia (CML)Phase 4CrescendoNCT01243489

Compliance: Role Emerges for Success in Chronic Myelogenous Leukaemia (CML): Evaluation aND Optimisation

A Phase 4 study testing compliance supporting measures in people with Chronic Myelogenous Leukemia (CML), run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 23 sites in Germany.

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 study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myelogenous Leukemia (CML)
What is being tested?
compliance supporting measures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
23 sitesGermany
Study dates
Oct 2010to Jun 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

  • Adult (> 18 years) CML patients in the chronic phase
  • Medical history of cytogenetically confirmed CML-CP by the presence of the Philadelphia chromosome on bone marrow aspirates (a minimum of 20metaphases is required; FISH cannot be used); Philadelphia chromosome negative but BCR- ABL-positive CML patients can be included
  • ECOG performance status of < 2
  • Imatinib treatment for at least 1 year and showing CCyR or MMR
  • Prior treatment with chemotherapeutics such as hydroxyurea or interferon- alpha is allowed
  • Prior periods of accelerated phases are allowed
Show all 9Show fewer
  • Negative pregnancy test for female patients of childbearing potential within 7 days before initiation of study drug
  • Ability to understand and willingness to sign a written informed consent document prior to any study related screening procedures
  • Written informed consent, including the consent to be called for interviews by the external, neutral institution.

Who cannot join

  • Patients with prior blast crisis or stem cell transplantation
  • Patients with severe medical condition(s) that in the discretion of the investigator prohibits participation in the study (e.g., clinically significant heart diseases, uncontrolled diabetes, active or uncontrolled infection, impaired gastrointestinal function/diseases)
  • Treatment with drugs or substances, especially those known to modify the cytochrome P450 activity, should be either discontinued or exchanged by different medication (see link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.)
  • Pregnant or breastfeeding women
  • Male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Onkologische Schwerpunktpraxis Celle

    Celle, 29221

  • Onkozentrum Dresden, Gemeinschaftspraxis Dres. Göhler & Dörfel

    Dresden, 01127

  • Gemeinschaftspraxis Hämatologie - Onkologie, BAG Freiberg-Richter / Jacobasch / Illmer / Wolf

    Dresden, 01307

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Erfurt, 99085

  • St.-Antonius-Hospital, Klinik für Hämatologie und Onkologie

    Eschweiler, 52249

  • IFS - Interdisziplinäres Facharztzentrum Sachsenhausen

    Frankfurt, 60596

  • Hämato-Onkologische Schwerpunktpraxis, Dres. Michael Metz, Andreas Ammon, Dirk Meyer

    Göttingen, 37073

  • MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung

    Hanover, 30171

  • Praxis für Innere Medizin, Onkologie und Hämatologie, Dr. Hahnfeld

    Jena, 07743

  • Universitätsklinikum Jena, Klinik für Innere Medizin II

    Jena, 07747

  • Gemeinschaftspraxis Dr. Siehl, Dr. Söling und Prof. Dr. Hirschmann

    Kassel, 34117

  • Gemeinschaftspraxis, Dres. Neise, Lollert

    Krefeld, 47805

  • Gemeinschaftspraxis, Dres. Ursula Vehling-Kaiser, Doris Greif

    Landshut, 84028

  • Internistische Schwerpunktpraxis Dr. Tschechne

    Lehrte, 31275

  • Onkologische Schwerpunktpraxis, Dres. Uthgenannt, Kisro, Weber

    Lübeck, 23562

  • Onkonet GbR, Praxis Dres. Weidenbach & Balser

    Marburg, 35037

  • Hämatologisch onkologische Schwerpunktpraxis

    Mayen, 56727

  • Nordbadpraxis

    München, 80797

  • Hämato - Onkologische Praxisgemeinschaft, Dr. Schmidt

    München, 81241

  • Praxis Dr. Walter

    Paderborn, 33102

  • Fachärzte für Innere Medizin, Hämatologie & Onkologie Rostock

    Rostock, 56727

  • Hämatologisch-Onkologische Gemeinschaftspraxis Würselen

    Würselen, 52146

  • Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie

    Würzburg, 97970

Other trials in Germany

About this study

Official title: CRESCENDO (Compliance: Role Emerges for Success in CML: Evaluation aND Optimisation): A Prospective, Multi-center, Phase IV Study to Assess the Compliance in Patients With Philadelphia Chromosome-positive (Ph+) and/or BCR-ABL Positive Chronic Myelogenous Leukaemia (CML) Under Long-term Imatinib Therapy

This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.

Being tested
compliance supporting measures
Keywords
CML, compliance, compliance supporting measures, complete cytogenetic response, mayor molecular remission, Philadelphia chromosome, BCR-ABL, Imatinib, tyrosine kinase inhibitor, smart blister
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Patient Compliance, Philadelphia Chromosome

What participants receive

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

  • compliance supporting measuresOther

    Patients will be treated for a total of 12 months, 6 months without and 6 months with compliance supporting measures. Patient can choose between an information service "Leben mit CML" or the use of a daily diary

Study groups in NCT01243489
Study groupRoleWhat they receive
patient diaryOthercompliance supporting measure: patients uses patient diary from month 6 to 12
Receives: Other: compliance supporting measures
Information service "Leben mit CML"Othercompliance supporting measure: patient uses the Information service "Leben mit CML"
Receives: Other: compliance supporting measures

What is being measured

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

  1. Patients compliance

    To assess patients compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention

    Measured: 12 months

Secondary outcomes (2)

  1. Compliance

    to correlate the compliance assessed by pill count (conventional pill count and pill count using SmartBlister in selected centers) with the results obtained by the questionnaires and interviews

    Measured: 12 months

  2. efficacy of imatinib

    to monitor the efficacy of imatinib as assessed by cytogenetics and PCR testing (BCR-ABL load, % IS)

    Measured: 12 months

Timeline

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

  1. First posted18 Nov 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionJun 2013
  4. Study completionJun 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01243489
Sponsor's protocol ID
CSTI571ADE75T
Other IDs
2010-018339-16
Acronym
Crescendo
Status last verified
Dec 2019
First submitted
17 Nov 2010
Last updated
20 Dec 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing compliance supporting measures in people with Chronic Myelogenous Leukemia (CML), run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 23 sites in Germany.

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 9 inclusion and 5 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 20 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 23 sites in Germany. 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?

Patients compliance (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 NCT01243489.

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 20 Dec 2019.

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