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CC-96191 for Acute Myeloid Leukemia

Phase 1
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and during the safety follow-up period.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

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.

Who is the study for?
Adults (≥18 years) with relapsed or refractory acute myeloid leukemia that is CD33 positive. They must have an ECOG performance status of 0 or 1, agree to use contraception, and have no available therapies left. Excluded are those with recent transplants, CNS leukemia, active infections like HIV or hepatitis B/C, heart issues, ongoing cancer treatments other than AML, and unresolved toxicities from past treatments.Check my eligibility
What is being tested?
The trial tests CC-96191 in adults with acute myeloid leukemia that's come back or hasn't responded to treatment. It has two parts: Part A finds the highest dose patients can take without bad side effects; Part B checks how well it works at this dose.See study design
What are the potential side effects?
Specific side effects for CC-96191 aren't listed but generally may include reactions where the drug enters the body, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, nausea and potential organ-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I will use birth control or practice abstinence during and after the study.
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My AML has returned or didn't respond to treatment, and I can't or won't try other treatments.
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It has been over 4 weeks since my last donor lymphocyte infusion.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AEs)
Dose limiting toxicities (DLTs)
Maximum tolerated dose (MTD)
Secondary outcome measures
Complete remission rate (CRR)
Duration of remission
Frequency of anti-drug antibodies (ADA)
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CC-96191Experimental Treatment1 Intervention
CC-96191 will be administered intravenously on a 28-day Cycle

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,901 Total Patients Enrolled
Marie Nguyen, MDStudy DirectorCelgene
3 Previous Clinical Trials
321 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,460 Total Patients Enrolled

Media Library

CC-96191 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04789655 — Phase 1
Myeloid Leukemia Research Study Groups: CC-96191
Myeloid Leukemia Clinical Trial 2023: CC-96191 Highlights & Side Effects. Trial Name: NCT04789655 — Phase 1
CC-96191 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789655 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia
2021. "Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04789655.
~15 spots leftby Feb 2025
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