← Back to Search

BCL-2 Inhibitor

CC-90009 for Leukemia and Myelodysplastic Syndrome

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 4 weeks has elapsed from donor lymphocyte infusion (DLI) without conditioning

Relapsed or refractory AML (Acute Myeloid Leukemia) or relapsed or refractory (R/R) higher-risk MDS (Myelodysplastic Syndrome) as defined by World Health Organization criteria who are not suitable for other established therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2.5 years

Awards & highlights

Study Summary

This trial is testing a new drug for people with leukemia or myelodysplastic syndrome who have not responded to other treatments.

Who is the study for?

Adults with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndrome (HR-MDS), who are not suitable for other therapies. Participants must have certain normal lab values, an ECOG Performance Status of 0-2, and cannot have had recent leukapheresis, CNS leukemia symptoms, significant graft-versus-host disease post-transplant, or recent cancer treatments.Check my eligibility

What is being tested?

The study is testing different doses of a drug called CC-90009 to find the safest and most effective amount for treating AML and HR-MDS. It's an early-phase trial where all participants receive CC-90009; there's no comparison group receiving another treatment.See study design

What are the potential side effects?

As this is a dose-finding study for CC-90009 in its early phase, specific side effects are being investigated. However, common side effects may include nausea, fatigue, blood count changes leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

It has been over 4 weeks since my last donor lymphocyte infusion without any prior preparation.

Select...

My AML or MDS has returned or didn't respond to treatment and I can't have standard therapies.

Select...

My kidneys are working well, with a creatinine clearance of 60 mL/min or more.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am 18 years old or older and have signed the informed consent document.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2.5 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

Dose- limiting toxicity (DLT)

Maximum tolerated dose (MTD)

Non-tolerated dose (NTD)

+7 more

Secondary outcome measures

Duration of remission

Duration of response

Event-free survival

+16 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: CC-90009 - Part B - AML and MDS patientsExperimental Treatment1 Intervention

Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A

Group II: CC-90009 - Part AExperimental Treatment1 Intervention

Will be administered intravenously per dosing schedule in a 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-90009

2020

Completed Phase 1

~10

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

637 Previous Clinical Trials

129,413 Total Patients Enrolled

August Dietrich, MDStudy DirectorCelgene

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,510 Previous Clinical Trials

3,371,024 Total Patients Enrolled

Media Library

CC-90009 (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02848001 — Phase 1

Myelodysplastic Syndrome Research Study Groups: CC-90009 - Part A, CC-90009 - Part B - AML and MDS patients

Myelodysplastic Syndrome Clinical Trial 2023: CC-90009 Highlights & Side Effects. Trial Name: NCT02848001 — Phase 1

CC-90009 (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02848001 — Phase 1

Frequently Asked Questions

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

Is there still an opportunity to partake in this medical experiment?

"Affirmative, the particulars available on clinicaltrials.gov indicate that this research endeavour is actively enrolling individuals in its study as of November 22nd 2022. The trial originally posted on November 14th 2016 and requires 162 participants to be recruited at 6 distinct sites."

Answered by AI

To what extent is this study population expanding?

"Affirmative. Clinicaltrials.gov's repository of information confirms that this clinical trial, which was initiated on November 14th 2016, is currently seeking participants. Approximately 162 patients must be recruited from 6 clinics or medical centres."

Answered by AI

What is the current scope of this experiment's implementation in medical settings?

"Currently, 6 different clinical sites are involved in the recruitment of participants. These include Boston, Hackensack and Saint Louis, amongst a few others. It is advantageous to select the clinic closest to you as this will reduce your travel requirements if chosen for participation."

Answered by AI

Has CC-90009 been granted regulatory approval by the Food and Drug Administration?

"As CC-90009 is undergoing its initial testing, the safety rating for this medication has been assessed as a 1 due to limited evidence of efficacy and safety."

Answered by AI

Recent research and studies

BloodJournal

CC-90009, a Novel Cereblon E3 Ligase Modulator, Targets Acute Myeloid Leukemia Blasts and Leukemia Stem Cells

Surka, Christine, Liqing Jin, Nathan Mbong, Chin-Chun Lu, In Sock Jang, Emily Rychak, Derek Mendy, et al.. 2021. “CC-90009, a Novel Cereblon E3 Ligase Modulator, Targets Acute Myeloid Leukemia Blasts and Leukemia Stem Cells”. Blood. American Society of Hematology. doi:10.1182/blood.2020008676.

clinicaltrials.govStudy

A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

2016. "A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02848001.

All > Acute Myeloid Leukemia > Paid Studies Connecticut