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Study Summary
This trial is testing a new drug, CC-96191, to see if it is safe and works against leukemia. The first part will test different doses to see what is safe. The second part will test it at a safe dose to see if it works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently receiving treatment for another cancer besides the one being studied.I haven't had cancer treatment or radiotherapy in the last 28 days or less than 5 half-lives of the drug, except for hydroxyurea.I am diagnosed or suspected to have a specific type of leukemia (APL).I had a stem cell transplant from a donor within the last 6 months.I have HIV, hepatitis B, or hepatitis C.I am fully active or restricted in physically strenuous activity but can do light work.I will use birth control or practice abstinence during and after the study.I still have serious side effects from past treatments that haven't improved.My AML has returned or didn't respond to treatment, and I can't or won't try other treatments.It has been over 4 weeks since my last donor lymphocyte infusion.I have or might have leukemia affecting my brain or spinal cord.I am 18 years old or older.I am on immunosuppressive therapy after a stem cell transplant or have significant graft-versus-host disease.I do not have heart problems as defined in the study.I haven't fully recovered from my last stem cell transplant according to my doctor.
- Group 1: CC-96191
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants are being recruited for this trial?
"Celgene is looking for 70 participants who meet the criteria to participate in this medical trial. The research will take place at sites such as The University of Texas - MD Anderson Cancer Center and Swedish Cancer Institute, among others."
Is this experiment actively recruiting participants at present?
"Correct. The information stored on clinicaltrials.gov verifies that this medical trial, which was first posted on June 16th 2021, is actively seeking participants. Approximately 70 individuals will be recruited from 11 different sites."
How many locations offer access to this clinical trial?
"Patients are being enrolled in this trial at several sites, including The University of Texas - MD Anderson Cancer Center (Houston, TX), Swedish Cancer Institute (Rochester, MN), and Mayo Clinic (Birmingham, AL). Additionally 11 more locations are participating."
Has the FDA provided its imprimatur to CC-96191?
"The safety of CC-96191 is assessed to be level 1, as the drug has only been tested in Phase 1 trials and therefore there is limited evidence validating its safety or efficacy."
What is the principal aim of this trial?
"According to Celgene, the principle outcome being measured after 42 days is Maximum Tolerated Dose. Secondary objectives include Volume of Distribution at Steady-State, Detection of Anti-Drug Antibodies within participants and Progression-Free Survival."
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