KPT-9274 in Patients with Relapsed and Refractory Acute Myeloid Leukemia

Launched by UNIVERSITY OF COLORADO, DENVER · Jun 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called KPT-9274 to see how safe it is for patients with relapsed or refractory acute myeloid leukemia (AML), which means that their cancer has come back or has not responded to other treatments. The trial is currently looking for participants aged 18 and older who have been diagnosed with a specific type of AML and have not found any effective treatment options available to them. To join, individuals must also be in reasonably good health, with manageable liver and kidney function.

Participants in the trial will take KPT-9274 and will be monitored closely by the medical team for any side effects or complications. This study aims to gather important information about how well this medication works and how well patients tolerate it. It's essential for potential participants to know that they will need to agree to certain safety precautions, including using effective birth control methods, and they should not be pregnant or breastfeeding. Overall, this trial represents an opportunity for patients with limited treatment options to contribute to research that may help improve future therapies for AML.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent obtained prior to any study related procedures required solely for this research study.
• • 2. Age ≥18 years.
• • 3. Patients with WHO-confirmed non-APL AML who have not responded to or relapsed after at least one prior therapy and for whom no standard therapy that may provide clinical benefit is available.
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• 5. Adequate hepatic function:
• • Total bilirubin \< 1.5 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\], subjects with Gilbert's syndrome, total bilirubin needs to be ≤ 4 x ULN).
• • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (except patients with known liver involvement of their AML who must have AST and ALT ≤ 5.0 times ULN).
• • 6. Adequate renal function: estimated creatinine clearance of ≥ 60 mL/min, calculated using CKD-EPI Creatinine Equation (2021). https://www.kidney.org/content/ckd-epi-creatinine-equation-2021
• • 7. Female patients of child-bearing potential must agree to use dual methods of contraception (including one highly effective and one effective method of contraception) and have a negative serum pregnancy test at Screening. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose.
• • 1. Fertile female patients must agree to refrain from egg donation from first dose until at least 3 months following the last dose of KPT-9724.
• • 2. Women should not breastfeed during treatment with KPT-9724 and for 2 weeks after the last dose.
• • 8. 8. Male patients must use 2 highly effective methods of contraception if sexually active with a female of child-bearing potential, during treatment with KPT-9724, during a period of 2 weeks (5 half-lives) after the last dose of KPT-9724 plus a period of 3 months. (for 3.5 months after their last dose of KPT-9724). Fertile male patients must agree to refrain from sperm donation from first dose until at least 3.5 months following the last dose of KPT-9724.
• Exclusion Criteria:
• • 1. Female patients who are pregnant or lactating.
• • 2. Radiation, chemotherapy, immunotherapy or any other anticancer therapy, including investigational anti-cancer therapy ≤ 2 weeks prior to C1D1. Hydroxyurea is not considered an anti-cancer therapy.
• • 3. Patients who have not recovered or stabilized (Grade 1 or to their baseline for non-hematologic toxicities) from toxicities related to their previous treatment, except for alopecia.
• • 4. White blood cell count ≥25x109/L (hydroxyurea or leukapheresis permitted to reduce to below the exclusion criteria threshold and allow eligibility)
• • 5. Patients with known active central nervous system (CNS) disease
• • 6. Clinically significant severe heart disease
• • 7. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment.
• • 8. Known, active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen). Testing is not required.
• • 9. Patients with significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-9274.
• • 10. Serious psychiatric or medical conditions that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give consent.