Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02348957
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Onco Medical Consult GmbH

Tracking Information
First Submitted Date December 15, 2014
First Posted Date January 28, 2015
Last Update Posted Date July 25, 2019
Study Start Date October 2014
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2015)
Distribution of Molecular remission status at study entry and after 12 months. [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 22, 2015)
  • Distribution of Molecular remission status at study entry and after 24 months. [ Time Frame: 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.
  • Best possible response [ Time Frame: Up to 36 months ]
    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)
  • Time to Molecular remission [ Time Frame: up to 36 months ]
    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
  • Time molecular progression [ Time Frame: Up to 36 months ]
    Patients start the observation period at study entry and reach this event, when a change to a higher BCR-ABL remission status is reached.
  • 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). [ Time Frame: Up to 36 months ]
    Cytogenetic response according to conventional cytogenetics (evaluation of at least 20 metaphase chromosomes) and hyper metaphase FISH (if applicable)
  • Hematologic response (HR) and complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS) [ Time Frame: Up to 36 months ]
    Complete blood count (if these parameters are routinely tested at the facility and are documented for the NIS
  • Patient Compliance/Adherence [ Time Frame: After 3,6,12,24 months ]
    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.
  • Patients' Satisfaction [ Time Frame: After 3,6,12,24 months ]
    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.
  • Quality of Life [ Time Frame: Time after 3,6,12,24 months ]
    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Time after 3,6,12,24 months ]
    Assessed at Baseline and analyzed over time after 3,6,12,24 months of observation.
  • Subgroup analysis concerning the primary study objective [ Time Frame: 12 months ]
    Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on the primary study aim.
  • Subgroup analysis concerning the time to remission [ Time Frame: Up to 36 months ]
    Common influencing factors like prognostic scores or previous therapy patterns are analyzed, whether they have an influence on time to remission
  • Subgroup analysis concerning the time to progression [ Time Frame: Up to 36 months ]
    Common influencing factors like age, sex or previous therapy patterns are analyzed, whether they have an influence on time to progression
  • Subgroup analysis concerning the quality of life and patient compliance [ Time Frame: Time after 3,6,12,24 months ]
    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
  • Subgroup analyses of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Time after 3,6,12,24 months ]
    Common influencing factors like age, sex, comorbidities or previous therapy patterns are analyzed, whether they have an influence on safety and toxicity
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib
Official Title Treating Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase (CP) With Dasatinib PCR-Monitoring, Adherence, Quality of Life, Therapy Satisfaction
Brief 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. 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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition Myeloid Leukemia, Chronic, Chronic-Phase
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 24, 2019)
223
Original Estimated Enrollment
 (submitted: January 22, 2015)
300
Actual Study Completion Date May 2019
Actual Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02348957
Other Study ID Numbers OMC 2014-I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Onco Medical Consult GmbH
Study Sponsor Onco Medical Consult GmbH
Collaborators Not Provided
Investigators
Principal Investigator: Hans Tesch, Prof. Dr. Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Im Prüfling 17, D-60389 Frankfurt am Main
PRS Account Onco Medical Consult GmbH
Verification Date July 2018