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Virus Therapy
BXCL701 for AML or MDS
Phase 1
Recruiting
Led By Eric S Winter, MD
Research Sponsored by Eric Stephen Winer, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks up to 1 year
Awards & highlights
Study Summary
This trial aims to find the safest and most effective dose of BXCL701 for AML or MDS.
Who is the study for?
Adults with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS), who have specific blood and organ function levels, can join. Those with HIV or hepatitis must be on effective treatment with an undetectable viral load. Participants should not have other active cancers, CNS leukemia involvement, or recent treatments that could interfere.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a drug called BXCL701 for AML/MDS patients. It aims to determine the best dose by monitoring participants' reactions over time.See study design
What are the potential side effects?
While specific side effects of BXCL701 are not listed here, common ones in cancer trials include nausea, fatigue, risk of infection due to low immunity, potential liver issues indicated by bilirubin/ALT/AST criteria in eligibility.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD)
Number of Participants with treatment related Adverse Events per CTCAE 5.0
Secondary outcome measures
Complete Remission (CR) Rate
Complete Response with Incomplete Count Recovery (CRi) Rate
Hematologic Improvement (HI) Rate
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation BXCL701Experimental Treatment1 Intervention
Dose escalation will occur using a 3+3 dose escalation approach, evaluating 4 different dose levels of BXCL701.
During each 28 day study cycle participants will take BXCL701 2x daily for up to 12 cycles.
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Who is running the clinical trial?
Eric Stephen Winer, MDLead Sponsor
Eric S Winter, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Acute Promyelocytic Leukemia.My acute myeloid leukemia has spread to my brain or spinal cord.I am eligible for this trial regardless of my gender or ethnicity.I can take care of myself but might not be able to do heavy physical work.I do not have unresolved health issues or conditions that could interfere with the trial.My organs are functioning well, and I understand the risks and consent.I am 18 years old or older.My condition is either relapsed or refractory AML, or I have a type of MDS with excess blasts-2.I have recently undergone chemotherapy, immunotherapy, or radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation BXCL701
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there potential for any adverse effects from administering Dose Escalation BXCL701?
"This Phase 1 trial has a limited amount of evidence regarding both safety and efficacy, leading our team at Power to rate the drug BXCL701 with a score of 1."
Answered by AI
Is this experiment enrolling new participants at present?
"Data on clinicaltrials.gov confirms that this particular trial is not taking any more participants, having been first posted in May of last year and the latest update being at the end of January 2021. Nonetheless, there are still 2777 other trials actively recruiting patients."
Answered by AI
What therapeutic effects are researchers hoping to achieve from this investigation?
"This trial will span 28-35 days and aims to determine the rate of treatment related Adverse Events as per CTCAE 5.0 standards. Secondary objectives include assessing Complete Response with Incomplete Count Recovery (CRi) Rate, Partial Response (PR) Rate, and Morphologic Leukemia-free State (MLFS) Rates based on International Working Group (IWG), European LeukemiaNet (ELN), 2017 ELN criteria for Acute Myeloid Leukemia and Myelodysplastic syndrome."
Answered by AI
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