RECRUITING

A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Unfit Newly Diagnosed AML

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

An open label multi centre study to assess the safety and efficacy of BST-236 in combination with venetoclax in adult patients unfit for standard therapy with newly diagnosed Acute Myeloid Leukemia (AML) Part 1 of the study will define the maximal tolerate dose of the combination treatment, while part 2 will expend the chosen dose, to assesses efficacy and safety of this combination. All patients will receive 2 induction courses with both BST-236 and venetoclax, responding patients will then be followed with up to 3 maintenance courses with BST-236 alone. Patients will be followed for 1 year in the study and additional 1 year in post study follow-up

Official Title

A Phase I/II Dose Escalation and Expansion Study of BST-236 Plus Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia Unfit for Intensive Induction Chemotherapy

Quick Facts

Study Start:2022-08-17

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05503355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult ≥18 years of age 2. Diagnosis of AML (de-novo AML or AML secondary to MDS or secondary to exposure to potentially leukemogenic therapies or agents) 3. Not eligible for standard induction chemotherapy 4. Peripheral white blood cell (WBC) count of \<25,000/μL 5. Creatinine clearance ≥45 mL/min 6. AST and/or aALT ≤2.5 X ULN) 7. Total bilirubin ≤1.5 x ULN 8. ECOG PS of: * 0 to 2 for patients ≥75 years of age * 0 to 3 for patients \<75 years of age 9. Women of reproductive potential must have a negative serum pregnancy test within 48 hours of Study Day 1	1. Patient has acute promyelocytic leukemia 2. Any previous treatment for AML 3. Patient has a known history of myeloproliferative neoplasm (MPN) 4. Patient has known active central nervous system (CNS) involvement with AML 5. Use of an investigational drug within 5 half-lives (or 30 days in case the half-life is unknown) prior to Study Day 1 6. Previous BM/stem cell transplantation (SCT) 7. Previous treatment for MDS with cytarabine, hypomethylating agents, or venetoclax 8. For Part 1 only - use of known strong or moderate CYP3A inducers within 7 days prior to Study Day 1 9. Patient has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to Study Day 1 10. Patient has a malabsorption syndrome or other condition that precludes enteral route of drug administration 11. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment) 12. Any medical or surgical condition, presence of clinical safety laboratory abnormalities, or psychiatric illness that may preclude safe and complete study participation based on the Investigator's judgment. 13. Diagnosis of malignant disease other than AML within the previous 12 months 14. Diagnosis of myeloid sarcoma as a sole manifestation of AML 15. Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) Class IV CHF 16. History of allergic reactions attributed to compounds of similar chemical composition as BST-236 and/or cytarabine and/or venetoclax. 17. Surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) in the 14 days prior to enrollment

Inclusion Criteria

Exclusion Criteria

1. Adult ≥18 years of age
2. Diagnosis of AML (de-novo AML or AML secondary to MDS or secondary to exposure to potentially leukemogenic therapies or agents)
3. Not eligible for standard induction chemotherapy
4. Peripheral white blood cell (WBC) count of \<25,000/μL
5. Creatinine clearance ≥45 mL/min
6. AST and/or aALT ≤2.5 X ULN)
7. Total bilirubin ≤1.5 x ULN
8. ECOG PS of:
* 0 to 2 for patients ≥75 years of age
* 0 to 3 for patients \<75 years of age
9. Women of reproductive potential must have a negative serum pregnancy test within 48 hours of Study Day 1

1. Patient has acute promyelocytic leukemia
2. Any previous treatment for AML
3. Patient has a known history of myeloproliferative neoplasm (MPN)
4. Patient has known active central nervous system (CNS) involvement with AML
5. Use of an investigational drug within 5 half-lives (or 30 days in case the half-life is unknown) prior to Study Day 1
6. Previous BM/stem cell transplantation (SCT)
7. Previous treatment for MDS with cytarabine, hypomethylating agents, or venetoclax
8. For Part 1 only - use of known strong or moderate CYP3A inducers within 7 days prior to Study Day 1
9. Patient has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to Study Day 1
10. Patient has a malabsorption syndrome or other condition that precludes enteral route of drug administration
11. Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
12. Any medical or surgical condition, presence of clinical safety laboratory abnormalities, or psychiatric illness that may preclude safe and complete study participation based on the Investigator's judgment.
13. Diagnosis of malignant disease other than AML within the previous 12 months
14. Diagnosis of myeloid sarcoma as a sole manifestation of AML
15. Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) Class IV CHF
16. History of allergic reactions attributed to compounds of similar chemical composition as BST-236 and/or cytarabine and/or venetoclax.
17. Surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) in the 14 days prior to enrollment

Contacts and Locations

Study Locations (Sites)

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: BioSight Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-17

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2022-08-17

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

AML, Adult