Last updated: December 20, 2021
Sponsor: Bayer
Overall Status: Terminated
Phase
1
Condition
Leukemia
Treatment
N/AClinical Study ID
NCT03404726
19420
2017-002896-24
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with relapsed or refractory AML. Relapsed AML is defined as relapse afterachieving a response to initial therapy and refractory AML is defined as failure toachieve a response after one previous line of therapy. Response is defined as per IWGcriteria (CR, CRi or CRp). Patients who are not candidates to receive or who declinestandard of care therapy are also eligible.
- Patients with intermediate-1 or higher risk MDS who have failed therapy with ahypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.
- Patients with relapsed/refractory CMML.
- Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m^2
- Patients must have adequate coagulation (international normalized ratio [INR] ≤ 1.5;activated partial thromboplastin time [aPTT] ≤1.5 X the upper limit of normal [ULN];patients on chronic anticoagulation therapy at investigator's discretion; patients onchronic use of direct-acting oral anticoagulants who have acceptable benefit-riskratio at investigator's discretion)
- Adequate liver function (total bilirubin ≤1.5 X ULN (or ≤3 X ULN in patients withdocumented Gilbert's syndrome or for patients with hyperbilirubinemia considered dueto myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] ≤3 X ULN (or ≤5 X ULN for patients with liver involvement of their myeloiddisease)
Exclusion
Exclusion Criteria:
- Patients eligible for hematopoietic stem cell transplantation
- Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNSleukemia
- Human immunodeficiency virus (HIV) infection
- Chronic or active hepatitis B or C if not controlled by antiviral therapy
- History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3months prior to first dose of study drug
- Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviraltherapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted
- Left ventricular ejection fraction (LVEF) <40%
Study Design
Total Participants: 40
Study Start date:
March 29, 2018
Estimated Completion Date:
January 26, 2021
Connect with a study center
Institut Gustave Roussy
Villejuif Cedex, 94805
FranceSite Not Available
Montefiore Medical Center
Bronx, New York 10467-2490
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
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