Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes
|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: NCT03824080|
Recruitment Status : Active, not recruiting
First Posted : January 31, 2019
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia High-risk Myelodysplastic Syndrome Low-risk Myelodysplastic Syndrome||Drug: Bemcentinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating the Efficacy and Safety of Bemcentinib in Patients With Myelodysplastic Syndromes Failing Standard of Care Therapy|
|Actual Study Start Date :||December 20, 2018|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||February 2023|
Bemcentinib will be self-administered orally (fasted) at a dose mentioned above for a total of at least 4 cycles without a treatment-free period in between.
Responding patients (as per criteria of European LeukaemiaNet and International MDS working Group (2006)) are eligible for up to 5 additional cycles according to the maintenance daily dosing of 2 x 1 capsules of 100 mg for each 28 days cycle (up to 9 cycles in total).
Bemcentinib will be self-administered orally (fasted) at a dose mentioned above for a total of at least 4 cycles daily.
Responding patients (defined as at least stable disease) are eligible for up to 5 additional cycles according to the maintenance daily dosing of 2 x 1 capsules of 100 mg for each 28 days cycle (up to 9 cycles in total).
- Assessment of efficacy of Bemcentinib for the treatment of AML and MDS patients failing or being refractory to hypomethylating agent treatment [ Time Frame: 17 weeks ]Overall hematological response rate
- Disease progression [ Time Frame: up to 9 month ]Disease progression measured by increase of bone marrow blasts
- Treatment failure [ Time Frame: up to 9 month ]Time to treatment failure
- Toxicity measured by NCI CTCAE 5.0 [ Time Frame: up to 9 month ]toxicity measured by NCI CTCAE 5.0
- Immunophenotyping [ Time Frame: up to 9 month ]Evaluating the role of potential biomarkers via flow-bases immunophenotyping of MDS and AML samples
- Biomarker analysis of Axl/Gas6 [ Time Frame: up to 9 month ]pAxl Analysis, gene expression and Axl immunohistochemistry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824080
|CHU Hôtel Dieu Service d'Hématologie Clinique|
|Nantes, Nantes Cedex 1, France, 44093|
|Service d'Hématologie Séniors|
|Paris, Paris 7, France, 75010|
|Hôpital Archet 1 Service d'Hématologie Clinique|
|Nice, France, 06200|
|Dresden, Germany, 01307|
|Marien Hospital GmbH|
|Leipzig, Germany, 04103|
|Technische Universität München, Klinikum rechts der Isar|
|VU University Medical Center|
|Amsterdam, Netherlands, 1081 HV|
|Principal Investigator:||Uwe Platzbecker, Prof.||Universitätsklinikum Leipzig|