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BMS-986253 for Myelodysplastic Syndrome
Phase 1 & 2
Waitlist Available
Led By Steven Z Pavletic, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have HR-MDS (R-IPSS >= 3.5) and received a minimum of 2 and maximum of 8 prior cycles for phase I and 4 for phase II of DNMTi therapy, or have LR-MDS (R-IPSS <3.5) and at least one cytopenia: granulocytes < 1.0 x 10^9/L and/or hemoglobin < 110 g/L with signs/symptoms of symptomatic anemia or transfusion-dependency, platelets < 100 x 10^9/L
ECOG performance status <=2 (Karnofsky >=60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new drug to treat myelodysplastic syndromes, to see if it is safe and effective. Eligible participants must be adults over 18, and treatment will happen in 28-day cycles.
Who is the study for?
Adults 18+ with Myelodysplastic Syndromes (MDS) who meet specific criteria, including having received certain prior treatments for MDS. They must have a life expectancy over 6 months and be able to perform daily activities with some degree of independence. Participants need proper liver and kidney function and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial is testing BMS-986253 alone or combined with decitabine and cedazuridine in treating MDS. It's given in cycles, with infusions on specific days, alongside oral medication for some participants. The goal is to see if this new drug combination is safe and effective against MDS.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to the infusion process, impacts on organ functions due to the drugs' actions, as well as general symptoms like fatigue or issues from changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have MDS with specific blood counts and have had certain treatments.
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I can take care of myself but might not be able to do active work.
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My condition is officially diagnosed as MDS.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: To determine MTD for BMS-986253 and RP2D, separately by cohort.
Phase II: To determine efficacy as measured by overall response rate, separately by cohort.
Secondary outcome measures
Phase 1: To describe pharmacokinetic properties of BMS-986253 in MDS patients by cohort.
Phase II: To evaluate safety and tolerability of BMS-986253 in MDS patients by cohort.
Trial Design
4Treatment groups
Experimental Treatment
Group I: phase II dose of BMS-986253 for LR-MDSExperimental Treatment1 Intervention
phase II dose of BMS-986253
Group II: phase II dose of BMS-986253 for HR-MDExperimental Treatment2 Interventions
phase II dose of BMS-986253 + DNMTi
Group III: escalating doses of treatment for LR-MDSExperimental Treatment1 Intervention
escalating doses of BMS-986253
Group IV: escalating dose of treatment for HR-MDSExperimental Treatment2 Interventions
escalating doses of BMS-986253 + DNMTi
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,655 Previous Clinical Trials
40,933,019 Total Patients Enrolled
Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,603 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active or uncontrolled autoimmune diseases.My liver and kidney functions meet the trial's requirements.I do not have any unmanaged ongoing illnesses.I have low platelet counts that don't respond to transfusions or dangerously low white blood cell counts.I can take care of myself but might not be able to do active work.I have not had any other cancer in the last 2 years.I have MDS with specific blood counts and have had certain treatments.I have had a stem cell transplant from a donor.I have chronic hepatitis B or C.I have high-risk MDS and have had less than 2 treatments with DNMTi.I do not have any major health issues that could affect my treatment.My condition is officially diagnosed as MDS.I am 18 years old or older.I am HIV-positive.
Research Study Groups:
This trial has the following groups:- Group 1: escalating doses of treatment for LR-MDS
- Group 2: phase II dose of BMS-986253 for LR-MDS
- Group 3: escalating dose of treatment for HR-MDS
- Group 4: phase II dose of BMS-986253 for HR-MD
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.
Have decitabine and cedazuridine been previously tested in any other clinical studies?
"At present, there are 104 active trials researching the effects of decitabine and cedazuridine. Of these, 16 have advanced into phase 3 clinical studies. The majority of the experiments occur in Philadelphia, Pennsylvania; although additional sites across 1491 locations are also conducting research on this treatment."
Answered by AI
How many participants are enrolled in this experiment?
"Affirmative. As per information on clinicaltrials.gov, this study is currently enrolling patients and was initially posted on December 1st 2022. The trial seeks to recruit 200 participants from a single site and its data has been recently updated as of November 25th 2022."
Answered by AI
How have decitabine and cedazuridine been traditionally used to treat patients?
"For patients in the intermediate-2 IPSS risk category, decitabine and cedazuridine are often prescribed. This treatment can also prove beneficial for high IPSS risk individuals, those with refractory anemias, or struggling with anemia."
Answered by AI
Is this research initiative open to new participants at present?
"According to clinicaltrials.gov, this medical investigation is presently enrolling participants and has been open for application since December 1st of 2022. It was last updated on November 25th of the same year."
Answered by AI
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