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Myeloid Leukemia, Chronic, Chronic-PhaseDasPAQTNCT02348957

Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib

An observational study of Myeloid Leukemia, Chronic, Chronic-Phase, run by Onco Medical Consult GmbH at 66 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

CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myeloid Leukemia, Chronic, Chronic-Phase
How many people
223 participants
Where
66 sitesGermany
Study dates
Oct 2014to May 2019
Phase
Observational
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This non-interventional study will document around 300 adult patients with newly-diagnosed CP-CML and CML patients in chronic phase resistant or intolerant to prior therapies, including Imatinib and Nilotinib.

Who may be able to join

  • Patients with newly diagnosed CP-CML and CML patients in chronic phase resistant or intolerant to prior therapies, including Imatinib. Any line treatment of chronic CML.
  • 18 years or older at time of diagnosis
  • Receiving treatment with Dasatinib according to the SmPC
  • Written informed consent obtained before any screening procedure and according to local guidelines

Who cannot join

  • •Patients who are participating in a clinical trial for CML treatment will be excluded

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

Germany66 sites

  • Praxisklinik für integrative Onkologie

    Altötting, Bavaria, 84503

  • MVZ Arnsberg

    Arnsberg, North Rhine-Westphalia, 59755

  • Gemeinschaftspraxis Drs. Klausmann

    Aschaffenburg, Bavaria, 63739

  • Klinikum Aschaffenburg Hämato-Onkologische Schwerpunktpraxis

    Aschaffenburg, Bavaria, 63739

  • Onkologische Schwerpunktpraxis Augsburg

    Augsburg, 86152

  • Onkologische Schwerpunktpraxis und Tagesklinik

    Bad Soden am Taunus, Hesse, 65812

  • Onkologische Gemeinschaftspraxis

    Bamberg, Bavaria, 96049

  • Onkologische Praxis Bautzen

    Bautzen, Saxony, 02625

  • Klinikum Bayreuth Klinik für Hämatologie und Onkologie

    Bayreuth, Bavaria, 95445

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Bayreuth, Bavaria, 95445

  • Vinzenz Pallotti Hospital GmbH

    Bergisch Gladbach, North Rhine-Westphalia, 51429

  • OVZ Friedrichshain Hämatologie, Onkologie und Palliativmedizin

    Berlin, 10407

  • Krebsheilkunde Lichtenberg

    Berlin, 13055

  • Praxis für Innere Medizin Ärztehaus Berlin-Pankow

    Berlin, 13187

  • Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie Charité - Universitätsmedizin Berlin

    Berlin, 13353

  • Klinikum Chemnitz gGmbH Klinik für Innere Medizin III

    Chemnitz, Saxony, 09113

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Cologne, North Rhine-Westphalia, 50677

  • Gemeinschaftspraxis für Hämatologie und Onkologie / Ambulante Tumortherapie

    Cologne, North Rhine-Westphalia, 51103

  • Onkologie Duisburg Nord

    Duisburg, 47166

  • Medizinisches Versorgungszentrum (MVZ) an der St. Marien-Hospital Düren gGmbH

    Düren, North Rhine-Westphalia, 52353

  • Gemeinschaftspraxis

    Eisenach, Thuringia, 99817

  • Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

    Frankfurt am Main, Hesse, 60389

  • Onko.Logix GmbH & Co. KG

    Gelsenkirchen, North Rhine-Westphalia, 45879

  • Onkologische Kooperation Harz

    Goslar, Lower Saxony, 38642

  • Gemeinschaftspraxis Dres med. Dirk Meyer & Andreas Ammon und Michael Metz

    Göttingen, Hesse, 37073

  • Intern. Gemeinschaftspraxis

    Güstrow, Mecklenburg-Vorpommern, 18273

  • Hämato-onkologische Praxis

    Halberstadt, Saxony-Anhalt, 38820

  • Onkologie Lerchenfeld

    Hamburg, 22081

  • Praxis für Hämatologie und Onkologie

    Hamm, North Rhine-Westphalia, 59065

  • Onkologische Schwerpunktpraxis

    Hanau, Hesse, 63450

  • Onkologisches Ambulanzzentrum Hannover

    Hanover, Lower Saxony, 30171

  • Praxis für Hämatologie und Onkologie

    Hanover, Lower Saxony, 30625

  • Praxis für Hämatologie und internistische Onkologie

    Heidenheim, Baden-Wurttemberg, 89518

  • Praxisklinik Hämatologie/Onkologie Herne

    Herne, North Rhine-Westphalia, 44623

  • Onkologische Schwerpunktpraxis Hildesheim

    Hildesheim, Lower Saxony, 31135

  • Onkologie Hof - Medizinisches Versorgungszentrum GmbH

    Hof, 95028

  • Klinikum Idar-Oberstein GmbH Medizinische Klinik I

    Idar-Oberstein, Rhineland-Palatinate, 55743

  • IDGGQ, Institut für med. Dokumentation GbR

    Kaiserslautern, Rhineland-Palatinate, 67655

  • Praxisklinik für Hämatologie und Onkologie Koblenz/ Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, Rhineland-Palatinate, 56068

  • Onkologische Schwerpunktpraxis

    Kronach, Bavaria, 96317

  • Hämatologie Onkologie Palliativmedizin Tagesklinik Landshut

    Landshut, Bavaria, 84028

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Langen, Hesse, 63225

  • Klinikum Lippe Onkologie und Hämatologie

    Lemgo, North Rhine-Westphalia, 32657

  • Praxis für Hämatologie, Onkologie und Palliativmed

    Mönchengladbach, North Rhine-Westphalia, 41066

  • Onkologische Schwerpunktpraxis Mülheim an der Ruhr und Oberhausen

    Mülheim, North Rhine-Westphalia, 45468

  • Facharztpraxis für Hämatologie und Onkologie, München

    München, Bavaria, 80331

  • Praxis für Hämatologie und Onkologie am Isartor

    München, Bavaria, 80331

  • MOP-Studiengesellschaft

    München, Bavaria, 80335

  • Hämatologische Praxisgemeinschaft München

    München, 81241

  • Internistische Praxis & Tagesklinik

    Neustadt, Saxony, 01844

  • Schwerpunktpraxis

    Neustadt am Rübenberge, Lower Saxony, 31535

  • Hämatologisch-onkologische Gemeinschaftspraxis Nordhorn

    Nordhorn, Niedersachen, 48527

  • Ambulantes Therapiezentrum

    Offenburg, Baden-Wurttemberg, 77654

  • MVZ für Blut- und Krebserkrankungen Potsdam

    Potsdam, Brandenburg, 14467

  • Schwerpunktpraxis und Tagesklinik dür Hämatologie und Onkologie/OncoPRO GbR

    Regensburg, Bavaria, 93053

  • Onkologische Praxis Remscheid

    Remscheid, North Rhine-Westphalia, 42589

  • Gemeinschaftspraxis für Hämatologie/Onkologie

    Rostock, Mecklenburg-Vorpommern, 18057

  • CaritasKlinikum Saarbrücken St. Theresia Akademisches Lehrkrankenhaus der Universität des Saarlandes

    Saarbrücken, Saarland, 66113

  • Gemeinschaftspraxis Drs. Georg Jacobs, Prof Heiner Daus und PD Dr. Schmits

    Saarbrücken, Saarland, 66113

  • Diakonie-Klinikum Schwäbisch Hall GmbH, Klinik für Innere Medizin III

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie

    Singen, 78224

  • Onkologische Schwerpunktpraxis Trier St. Anna / Brüderkrankenhaus

    Trier, 54292

  • Fachärztliche Gemeinschaftspraxis

    Weiden, Bavaria, 92637

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Westerstede, 26655

  • Dres. Klaus Maria Josten und Ortwin Klein

    Wiesbaden, Hesse, 65191

  • Ambulante Onkologie Ostsachsen

    Zittau, Saxony, 02763

Other trials in Germany

About this study

Official title: Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib PCR-Monitoring, Adherence, Quality of Life, Therapy Satisfaction

CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Although Imatinib has demonstrated unprecedented efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML is managed in real-life clinical practice settings. Therefore this non-interventional study is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine with respect to first and second line treatment and/or switch setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered doctor's practices as here most of CML patients who are not involved in clinical trials are treated.

Read the detailed description

The advent of Imatinib into the market in 2001 changed the treatment paradigm of CML. Seven-year follow-up from the IRIS trial revealed an estimated overall survival of 86% in newly diagnosed CML patients treated with Imatinib.

In June 2006, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Dasatinib to treat adults with CP-CML with resistant disease or who were intolerant to prior therapy, including Imatinib. The FDA converted Dasatinib to a regular approval in May 2009, after confirmation of the treatment's safety and effectiveness. On October 28, 2010, FDA granted accelerated approval to Dasatinib for the treatment of newly diagnosed adult patients with CML-CP. Dasatinib entered thereby a marketplace with other TKIs including Nilotinib.

According to the summary of product characteristics brochure Dasatinib (Sprycel®) is indicated for the treatment of adult patients with:

  • Newly diagnosed Ph+ CML In the chronic phase.
  • Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including Imatinib mesilate.
  • Ph+ acute lymphoblastic leukaemia and lymoid blast CML with resistance or intolerance to prior therapy.

A phase III study (DASISION) of Dasatinib vs. Imatinib could proof that Dasatinib induced significantly higher and faster rates of complete cytogenetic response and major molecular response when compared to Imatinib. Since achieving complete cytogenetic response within 12 months has been associated with better long-term, progression-free survival, Dasatinib may improve the long-term outcomes among patients with newly diagnosed chronic-phase CML.

Nevertheless, further data are required to obtain additional information on the clinical benefits of Dasatinib.

CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Dasatinib is approved for the treatment of newly diagnosed PH+ CP-CML and CML in chronic or accelerated phase or blast crisis in patients resistant or intolerant to prior therapies including Imatinib. Although Imatinib has demonstrated exceptional efficacy in clinical trials, mostly in chronic phase CML, there is lack of published data on how CML is managed in real-life clinical practice settings.

Therefore this non-interventional study is designed to collect real-life data on CML-treatment with Dasatinib in clinical routine with respect to first and second line treatment and/or switch setting (within 1st line or from 1st line TKI to 2nd line Dasatinib). Emphasis lies on health care provided in registered doctor's practices as here most of CML patients who are not involved in clinical trials are treated.

Keywords
Chronic myeloid leukemia, Dasatinib, Any line, Chronic phase
Medical subject headings
Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What is being measured

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

  1. Distribution of Molecular remission status at study entry and after 12 months.

    Patients included into this study are on a treatment with Dasatinib. Fraction of BCR-ABL positive cells is measured at study entry or was assessed at the timepoint of Dasatinib treatment begin and classified as >MR3, MR3, MR4, and MR4.5 as an ordinal measure.

    Molecular Fraction of BCR-ABL positive cells is reassessed after 12 months.

    Measured: 12 Months

Secondary outcomes (15)

  1. Distribution of Molecular remission status at study entry and after 24 months.

    Patients included into this study are on a treatment with Dasatinib. Fraction of BCR-ABL positive cells is measured at study entry or was assessed at the time point of Dasatinib treatment begin and classified as >MR3, MR3, MR4, and MR4.5 as an ordinal measure.

    Molecular Fraction of BCR-ABL positive cells is reassessed after 24 months.

    Measured: 24 months

  2. Best possible response

    Defined as the best response at any time after the start of the treatment. Reported will be distributions for each response (progression, stable disease, remission for at least one class of MR)

    Measured: Up to 36 months

  3. Time to Molecular remission

    Patients reach this event, when a change from a higher amount of BCR-ABL positive patients to a lower amount of BCR-ABL positive patients occurs

    Measured: up to 36 months

  4. Time molecular progression

    Patients start the observation period at study entry and reach this event, when a change to a higher BCR-ABL remission status is reached.

    Measured: Up to 36 months

  5. Cytogenetic profile at start of Dasatinib treatment, type of BCR-ABL transcript (if these parameters are routinely tested at the facility and are documented for the NIS).

    Cytogenetic response according to conventional cytogenetics (evaluation of at least 20 metaphase chromosomes) and hyper metaphase FISH (if applicable)

    Measured: Up to 36 months

  6. Hematologic response (HR) and complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS)

    Complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS

    Measured: Up to 36 months

  7. Patient Compliance/Adherence

    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.

    Measured: After 3,6,12,24 months

  8. Patients' Satisfaction

    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.

    Measured: After 3,6,12,24 months

  9. Quality of Life

    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.

    Measured: Time after 3,6,12,24 months

  10. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.

    Measured: Time after 3,6,12,24 months

  11. Subgroup analysis concerning the primary study objective

    Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on the primary study aim.

    Measured: 12 months

  12. Subgroup analysis concerning the time to remission

    Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on time to remission

    Measured: Up to 36 months

  13. Subgroup analysis concerning the time to progression

    Common influencing factors like age, sex or previous therapy patterns are analyzed, whether they have an influence on time to progression

    Measured: Up to 36 months

  14. Subgroup analysis concerning the quality of life and patient compliance

    Common influencing factors like age, sex, comorbidities or previous therapy patterns are analyzed, whether they have an influence on quality of life and patient compliance

    Measured: Time after 3,6,12,24 months

  15. Subgroup analyses of participants with Adverse Events as a Measure of Safety and Tolerability

    Common influencing factors like age, sex, comorbidities or previous therapy patterns are analyzed, whether they have an influence on safety and toxicity

    Measured: Time after 3,6,12,24 months

Timeline

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

  1. First posted28 Jan 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionMar 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02348957
Sponsor's protocol ID
OMC 2014-I
Acronym
DasPAQT
Status last verified
Jul 2018
First submitted
15 Dec 2014
Last updated
25 Jul 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Myeloid Leukemia, Chronic, Chronic-Phase, run by Onco Medical Consult GmbH at 66 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 4 inclusion and 1 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 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.

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?

Distribution of Molecular remission status at study entry and after 12 months. (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 NCT02348957.

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 25 Jul 2019.

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