Study Summary
This trial is testing a new drug for people with leukemia or myelodysplastic syndrome who have not responded to other treatments.
Eligible Conditions
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
10 Primary · 22 Secondary · Reporting Duration: Up to 2.5 years
Up to 2.5 years
Duration of remission
Duration of response
Event-free survival
Overall survival
Preliminary efficacy of CC-90009
Preliminary efficacy of CC-90009 - AML
Preliminary efficacy of CC-90009 - Higher-risk myelodysplastic syndromes (HR-MDS)
Preliminary efficacy of CC-90009 - MDS
Leukemia, Myelocytic, Acute
Progression-free survival
Relapse-free survival
Time to AML transformation
Time to remission for AML participants
Time to remission for HR-MDS participants
Time to response for AML participants
Time to response for HR-MDS participants
Up to 42 days
Dose- limiting toxicity (DLT)
Maximum tolerated dose (MTD)
Non-tolerated dose (NTD)
Number of participants with Adverse Events (AEs)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
Number of participants with Left Ventricle Ejection Fraction (LVEF) assessment abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with laboratory abnormalities
Number of participants with physical examination abnormalities
Number of participants with vital sign abnormalities
Up to Day 11
Pharmacokinetics - AUC24
Pharmacokinetics - CL
Pharmacokinetics - Vss
Pharmacokinetics - t 1/2
Pharmacokinetics - tmax
Pharmacokinetics-Cmax
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
CC-90009 - Part B - AML and MDS patients
1 of 2
CC-90009 - Part A
1 of 2
Experimental Treatment
162 Total Participants · 2 Treatment Groups
Primary Treatment: CC-90009 · No Placebo Group · Phase 1
CC-90009 - Part B - AML and MDS patients
Drug
Experimental Group · 1 Intervention: CC-90009 · Intervention Types: DrugCC-90009 - Part A
Drug
Experimental Group · 1 Intervention: CC-90009 · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-90009
2020
Completed Phase 1
~10
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2.5 years
Who is running the clinical trial?
CelgeneLead Sponsor
625 Previous Clinical Trials
172,987 Total Patients Enrolled
August Dietrich, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,407 Previous Clinical Trials
3,309,005 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have IPSS-R high or IPSS-R very high risk.
Corrected serum calcium (Ca) or free (ionized) serum calcium (Ca) within normal limits (WNL).
You must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted.
You have an ECOG PS of 0 to 2.
References
- 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.
- 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.
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Conditions
Cancer Related
Treatments