Status:
TERMINATED
Study in Patients With Chronic Leukemia
Lead Sponsor:
GWT-TUD GmbH
Collaborating Sponsors:
Incyte Biosciences International Sàrl
Conditions:
Leukemia, Myeloid, Chronic-Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will include patients suffering from chronic myeloid leukemia (CP-CML), who were treated with tyrosine kinase inhibitor (TKI, a substance that blocks the action of enzymes) in a previous th...
Detailed Description
Despite significant progress in the treatment of patients with chronic phase CML, there is still need to further optimize therapy to reach the goal of disease eradication for almost all patients. In c...
Eligibility Criteria
Inclusion
- Male or female patients ≥18 years old
- Diagnosis of Ph-positive (by cytogenetics) or BCR-ABL-positive (by PCR) CP-CML
- Patients should have demonstrated to have
- a failure of a prior 1st line TKI treatment with either imatinib, dasatinib or nilotinib. Failure is defined as per European LeukemiaNet (ELN) recommendations:
- Less than Complete Hematologic Response (CHR) and/or Ph+ \> 95% at or beyond 3 months
- No cytogenetic response (Ph+\>35%) and/or Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) \>10% at or beyond 6 months
- BCR-ABL (on international scale) \>1% and/or PH+ \>0%
- Less than MMR at or beyond 18 months
- Loss of response or development of mutations or other clonal chromosomal abnormalities at any time during the first line TKI treatment
- or intolerance to prior TKI treatment defined as grade 3 or 4 toxicity, or persistent grade 2 toxicity despite optimal management including dose adjustment, or in a patient where dose reductions are considered to be not in the patient's best interest to obtain an adequate response. Intolerant patients should not have achieved or have lost major molecular response at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion
- Any 1st line anti-CML treatment other than TKI (apart from therapy with hydroxyurea)
- Any 2nd line therapy with a tyrosine kinase inhibitor (\>1 European Medicines Agency (EMA) approved TKI for CML, or any investigational non EMA-approved TKI)
- Concurrent participation in any other clinical trial involving another investigational drug within 4 weeks prior to enrollment and throughout participation in PONS-Study
- New York Heart Association (NYHA) cardiac class 3-4 heart disease
- Cardiac Symptoms within the past 12 months prior recruitment
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03807479
Start Date
December 11 2018
End Date
August 31 2023
Last Update
September 14 2023
Active Locations (10)
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1
University Hospital
Halle, Saxony-Anhalt, Germany, 06097
2
University Hospital RWTH Aachen,Clinic for Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Medical Department IV
Aachen, Germany, 52074
3
Charité University Medicine Berlin - Medical Clinic, Department of Hematology, Oncology and Tumor Immunology
Berlin, Germany, 13353
4
University Hospital Essen gGmbH, Westdeutsches Tumorzentrum; Internal Medicine (Tumor Research)
Essen, Germany, 45122