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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed or refractory acute myeloid leukemia (R/R AML) and relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS) as defined by the World Health Organization (WHO) criteria who have failed or are ineligible for all available therapies which may provide clinical benefit
Participant has Eastern Cooperative Oncology Group Performance Status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing a new drug, CC-91633, for people with relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes. The first part of the trial will test different doses of the drug to find a safe and tolerable dose. The second part of the trial will test the efficacy of the selected dose.
Who is the study for?
Adults with relapsed or refractory acute myeloid leukemia (R/R AML) or higher-risk myelodysplastic syndromes (R/R HR-MDS), who have not responded to available treatments. They should be in a stable condition, without severe complications like uncontrolled infection/bleeding, and meet specific health criteria such as adequate liver function and no active hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing CC-91633 (BMS-986397), an oral medication for R/R AML and R/R HR-MDS. It's a Phase 1 study with two parts: dose escalation to find the maximum tolerated dose, followed by expansion to confirm tolerability and assess preliminary efficacy.See study design
What are the potential side effects?
While specific side effects of CC-91633 are not listed here, common ones for cancer drugs may include nausea, fatigue, risk of infection due to low blood cell counts, liver issues, diarrhea or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia or myelodysplastic syndrome has not improved with treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My liver tests are within the normal range, or slightly above if due to my leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting Toxicity (DLT)
Incidence of Adverse Events (AEs)
Maximum Tolerated Dose (MTD)
Secondary outcome measures
CC-2004772 Pharmacokinetics - AUC(0-T)
CC-2004772 Pharmacokinetics - AUC(TAU)
CC-2004772 Pharmacokinetics - CLT/F
+27 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Participants with Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes (HR-MDS)Experimental Treatment1 Intervention
Part B (expansion part) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R HR-MDS participants.
Group II: Participants with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)Experimental Treatment1 Intervention
Part B (expansion part) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R AML participants.
Group III: Participants with R/R AML and R/R HR-MDS - Part AExperimental Treatment1 Intervention
Part A (Dose Escalation) of the study will enroll R/R AML (Relapsed or Refractory Acute Myeloid Leukemia) and R/R HR-MDS (Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes) participants and will evaluate the safety and tolerability of escalating doses of CC-91633, administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 dose (RP2D) and schedule.
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Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,734 Total Patients Enrolled
Tim Campbell, MD, PhDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,703 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for another cancer besides the one being studied.I have heart problems that affect my daily activities.My leukemia or myelodysplastic syndrome has not improved with treatment.I have severe diarrhea, vomiting, or issues absorbing medication.I have been diagnosed with acute promyelocytic leukemia.I have an ongoing hepatitis B or C infection.My bilirubin levels are normal or slightly elevated due to Gilbert's syndrome.I am currently on long-term blood thinners.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.I had major surgery less than 2 weeks ago but have recovered from its major effects.My kidneys work well, with a creatinine clearance of 60 mL/min or more.I have or might have leukemia in my brain or spinal cord.My liver tests are within the normal range, or slightly above if due to my leukemia.I do not have severe, life-threatening complications from leukemia like uncontrolled infection or bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes (HR-MDS)
- Group 2: Participants with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
- Group 3: Participants with R/R AML and R/R HR-MDS - Part A
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.
What adverse effects has CC-91633 been shown to cause?
"There is only a small amount of evidence available concerning CC-91633's safety and efficacy, so it received an appraisal of 1."
Answered by AI
What outcomes is this experiment seeking to accomplish?
"As reported by the study sponsor, Celgene, the main metric that will be monitored over a maximum of 4 years is Maximum Tolerated Dose (MTD). Asides from this primary outcome measure, other key metrics such as Area under the plasma concentration time-curve from time 0 to 24 hours postdose and Half-life shall also be assessed."
Answered by AI
How many medical facilities have implemented the trial protocol?
"This medical experiment is currently running at 6 separate sites, 3 of which are in Houston, Chicago and La Jolla. Other locations are also available for potential participants to consider when selecting a trial location that best suits their needs."
Answered by AI
What is the enrollment cap for this research experiment?
"Affirmative. The information available on clinicaltrials.gov reveals that this medical experiment is still welcoming volunteers; it was first posted in December 2nd 2021 and has been updated as recently as September 16th 2022. 120 individuals need to be registered from 6 distinct sites."
Answered by AI
Is there still capacity to include participants in this research?
"The trial, which was initially posted on December 2nd 2021, is currently recruiting according to clinicaltrials.gov's information and the study has undergone its most recent update as of September 16th 2022."
Answered by AI
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