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

Sponsored by BioSight Ltd.

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Current Status

Unknown

Auto-verified from ClinicalTrials.gov

Verified Apr 4, 2023

Phase

Clinical Trial

Sponsor

BioSight Ltd.

Enrollment Target

80

Start Date

Aug 2022

๐Ÿ“Š
1 of 80 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Adult โ‰ฅ18 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/ฮผL 5. Creatinine clearance โ‰ฅ45 mL/min 6. AST and/or aALT โ‰ค2.5 X ULN) 7. Total bilirubin โ‰ค1.5 x ULN 8. ECOG PS of:
0 to 2 for patients โ‰ฅ75 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

Exclusion Criteria

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

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

80 participants

๐ŸŽ‚

Age Range

18 Years - 90 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

BioSight Ltd.

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Chicago

Illinois

Location available
View Chicago location page
RECRUITING

Houston

Texas

Location available
View Houston location page
RECRUITING

Charlottesville

Virginia

Location available
View Charlottesville location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Looking for Acute Myeloid Leukemia Treatment in Chicago?

Join others in Illinois exploring innovative treatment options through clinical research

Acute Myeloid Leukemia Treatment Options in Chicago, Illinois

If you're searching for Acute Myeloid Leukemia treatment in Chicago, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chicago, Houston, Charlottesville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Acute Myeloid Leukemia. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Illinois
Now Enrolling
Up to 80 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Acute Myeloid Leukemia?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Acute Myeloid Leukemia

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Acute Myeloid Leukemia Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05503355. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.