Leukemia, Myeloid, AcutePhase 1NCT02848001
A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
A Phase 1 study testing CC-90009 in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Celgene at 20 sites in 6 countries.
Trial summary
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- What is being tested?
- CC-90009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 14 Nov 2016to 11 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent Document).
- Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted.
- Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory (R/R) higher-risk MDS (Myelodysplastic Syndrome) (HR-MDS) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies.
- In Part A, R/R AML
- In Part B, R/R AML including
- Relapsed after allogeneic HSCT or
Show all 27Show fewer
- In second or later relapse or
- Refractory to initial induction or re-induction treatment or
- Refractory or relapse after HMA treatment (HMA failure defined as primary progression or lack of clinical benefit after a minimum of 6 cycles or unable to tolerate HMA due to toxicity) or
- Refractory within 1 year of initial treatment (excluding those with favorable risk based on cytogenetics)
- In Part B, R/R HR-MDS (Revised International Prognostic Scoring System score (IPSS-R) > 3.5 points, IPSS-R calculated during screening period):
- IPSS-R intermediate risk (in combination with more than 10% bone marrow blasts or poor or very poor IPSS-R cytogenetic risk) or
- IPSS-R high or
- IPSS-R very high risk
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
- At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI) without conditioning.
- Subjects must have the following screening laboratory values:
- Corrected serum Ca or free (ionized) serum Ca within normal limits (WNL).
- o Corrected Ca (mg/dL) = Total Ca (mg/dL) - 0.8 (albumin [g/dL] - 4)
- Total White Blood Cell count (WBC) < 25 x 10^9/L prior to first infusion. Prior or concurrent treatment with hydroxyurea to achieve this level is allowed.
- Potassium and magnesium within normal limits or correctable with supplements.
- Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamate pyruvic transaminase (ALT/SGPT) ≤ 2.5 x Upper Limit of Normal (ULN).
- Uric acid ≤ 7.5 mg/dL (446 μmol/L). Prior and/or concurrent treatment with hypouricemic agents (eg, allopurinol, rasburicase) are allowed.
- Selected electrolytes within normal limits or correctable with supplements.
- Serum bilirubin ≤ 1.5 x ULN (upper limit of normal).
- Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated.
- International normalized ratio (INR) < 1.5 x ULN and Partial thromboplastin time (PTT) < 1.5 x ULN.
Who cannot join
- Subjects with acute promyelocytic leukemia (APL)
- Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is clinical suspicion of CNS involvement by leukemia during screening.
- Patients with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (e.g., transplant related side effects).
- Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90009.
- Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD).
- Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks prior to starting CC-90009, whichever is shorter. Hydroxyurea is allowed to control peripheral leukemia blasts.
- Leukapheresis ≤ 2 weeks prior to starting CC-90009.
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
United States6 sites
Local Institution - 103
Boston, Massachusetts, 02115
Local Institution - 102
Chicago, Illinois, 60611
Local Institution - 104
Hackensack, New Jersey, 07601
Local Institution - 105
New Haven, Connecticut, 06510
Local Institution - 101
St Louis, Missouri, 63110
Stanford Cancer Center
Stanford, California, 94305
Spain6 sites
Local Institution - 603
Badalona, 8916
Local Institution - 602
Barcelona, 08036
Local Institution - 604
Madrid, 28033
Local Institution - 605
Pamplona, 31008
Local Institution - 601
Salamanca, 37007
Local Institution - 600
Valencia, 46009
France4 sites
Local Institution - 505
Lillie Cedex, 59037
Institut Paoli Calmettes
Marseille, 13273
Hopital Lyon Sud
Pierre-Bénite, 69310
Local Institution - 502
Toulouse, 31059
Norway2 sites
Local Institution - 700
Bergen, N-5053
Local Institution - 701
Oslo, N-0027
About this study
Official title: A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.
Read the detailed description
Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion, first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory higher-risk myelodysplastic syndrome.
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B), will further evaluate the safety and efficacy of CC-90009 administered at or below the maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or refractory AML and relapsed or refractory higher-risk myelodysplastic syndrome.
- Being tested
- CC-90009
- Keywords
- CC-90009, Hematologic Cancers, Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, AML, MDS
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90009Drug
CC-90009
| Study group | Role | What they receive |
|---|---|---|
| CC-90009 - Part A | Experimental | Will be administered intravenously per dosing schedule in a 28-day cycle. Receives: Drug: CC-90009 |
| CC-90009 - Part B - AML and MDS patients | Experimental | Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A Receives: Drug: CC-90009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicity (DLTs)
A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.
Measured: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Secondary outcomes (30)
Non-Tolerated Dose (NTD) of CC-90009
The NTD is defined as a dose level at which 2 or more of up to 6 evaluable participants in any dose cohort experience a DLT in Cycle 1 during dose escalation (Part A)
Measured: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Maximum Tolerated Dose (MTD) of CC-90009
The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable participants experiencing a DLT in Cycle 1 during dose escalation (part A).
Measured: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Treatment-emergent adverse events (TEAEs) are defined as any AEs that begin on or after the start of study drug through 28 days after the last dose of study drug or serious AEs that are suspected of being related to study drug.
Measured: From first dose until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 1
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 2
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 3
Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 1
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 2
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 3
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 4
Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1
Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2
Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Eastern Cooperative Oncology Group (ECOG) Performance Status
Number of participants with post-baseline grade increase or decrease from baseline. Grade 0=; Grade 1=; Grade 2=; Grade 3=; Grade 4=; Grade 5=; . Baseline = last value before start of treatment.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline
Left Ventricular Ejection Fraction (LVEF) percent change from baseline. Baseline = last value before start of treatment.
Minimum Post Baseline Value=lowest value of the measured parameter is recorded after the baseline measurement.
Maximum Post Baseline Value=highest value of the measured parameter is recorded after the baseline measurement.
Measured: From baseline until 28 days post last dose (Up to 25 months)
Objective Response Rate (ORR)
Objectve response is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)) or Morphologic Leukemia - Free State or partial remission. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
Measured: Up to approximately 25 months after the last dose
Overall Survival (OS)
OS is defined as the time from the date of the first dose to the date of death from any cause.
Measured: Up to approximately 25 months after the last dose
Relapse-free Survival (RFS)
RFS is defined only for participants who achieved CR or CRi (for AML) / CR or PR (for MDS) and is measured as the interval from the date of first CR or CRi (for AML) / CR or PR (for MDS) to the date of relapse or death from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.
Measured: Up to approximately 25 months after the last dose
Progression-free Survival (PFS)
PFS is defined as the time from the date of the first dose to the date of first relapse after CR/CRi (for AML)/relapse after CR/PR(for MDS), or PD, or death resulting from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Measured: Up to approximately 25 months after the last dose
Event-free Survival (EFS)
EFS is defined as the interval from the date of the first dose to an event including disease progression (PD), treatment failure, relapse, or death from any cause, whichever occurs first. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Measured: Up to approximately 25 months after the last dose
Duration of Remission/Response (DOR)
DOR is defined as the time from first remission/response observed to the date of relapse, death or PD. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.
Measured: Up to approximately 25 months after the last dose
Time to Remission/Response (TTR)
TTR is defined as the time between the date of first dose and the earliest date any remission/response (any complete remissions or partial remissions or better) is observed. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. Based on Kaplan-Meier Estimates.
Measured: Up to approximately 25 months after the last dose
Complete Remission Rate (CRR)
The complete remission rate (CRR) is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)). CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD.
Measured: Up to approximately 88 months
Time to Acute Myeloid Leukemia (AML) Transformation
Time to acute AML transformation in part B Myelodysplastic Syndromes (MDS) participants only. Based on Kaplan-Meier Estimates.
Measured: Up to approximately 88 months
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data
Measured: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10,
Time to Peak Plasma Concentration (Tmax)
Time to peak plasma concentration, obtained directly from the observed concentration versus time data.
Measured: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)
Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose.
Measured: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Terminal Phase Elimination Half-life (T1/2)
Terminal phase elimination half-life calculated as [(ln 2)/λz], where λz is the apparent terminal rate constant. t1/2 will only be calculated when a reliable estimate for λz can be obtained.
Measured: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days
Total Body Clearance (CL)
Total plasma clearance after IV administration, calculated as [Dose/ AUC(INF)] following single administration, and [Dose/ AUC(0-24)] at steady state.
Measured: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Volume of Distribution (Vz)
Volume of distribution calculated at first dose only. Calculated as [Vz = Dose/ AUC(INF) * λz for Day 1].
Measured: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days
Renal Clearance (CLr)
Renal clearance of CC-90009 (CLr)
Measured: Cycle 1 Day 1(C1D1). 1 cycle = 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start14 Nov 2016
- Primary completion11 Apr 2023
- Study completion11 Apr 2024
Why it stopped: Trial terminated because of lack of efficacy in the short term acute phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848001
- Sponsor's protocol ID
- CC-90009-AML-001
- Other IDs
- 2017-001535-39, 2017
- Status last verified
- May 2025
- First submitted
- 22 Jun 2016
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.
PubMed 33197925
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT02848001
- Acronym / sponsor ID
- CC-90009-AML-001
- Keywords
- CC-90009, Hematologic Cancers, Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, AML, MDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial terminated because of lack of efficacy in the short term acute phase.
- Enrolment
- 101 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia and relapsed or refractory higher-risk myelodysplastic syndrome.
Detailed description
Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion, first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory higher-risk myelodysplastic syndrome.
The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009 in relapsed and refractory AML. The expansion part, (Part B), will further evaluate the safety and efficacy of CC-90009 administered at or below the maximum tolerated dose (MTD) in selected expansion cohorts of one or more dosing regimens in order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or refractory AML and relapsed or refractory higher-risk myelodysplastic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC-90009 - Part A | Experimental | Drug: CC-90009Will be administered intravenously per dosing schedule in a 28-day cycle. |
| CC-90009 - Part B - AML and MDS patients | Experimental | Drug: CC-90009Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent Document).
- Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted.
- Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory (R/R) higher-risk MDS (Myelodysplastic Syndrome) (HR-MDS) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
- At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI) without conditioning.
Key exclusion criteria (7 listed)
- Subjects with acute promyelocytic leukemia (APL)
- Subjects with clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid is only required if there is clinical suspicion of CNS involvement by leukemia during screening.
- Patients with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (e.g., transplant related side effects).
- Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90009.
- Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-90009CC-90009 | Drug | CC-90009 - Part A, CC-90009 - Part B - AML and MDS patients |
Primary outcome
Number of Participants With Dose Limiting Toxicity (DLTs)
Time frame: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.
30 secondary outcomes
Non-Tolerated Dose (NTD) of CC-90009
Time frame: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Maximum Tolerated Dose (MTD) of CC-90009
Time frame: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 1
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 2
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline by Laboratory Test - Chemistry Parameters 3
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 1
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 2
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 3
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Vital Signs by Test - Parameters 4
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline
Time frame: From baseline until 28 days post last dose (Up to 25 months)
Objective Response Rate (ORR)
Time frame: Up to approximately 25 months after the last dose
Overall Survival (OS)
Time frame: Up to approximately 25 months after the last dose
Relapse-free Survival (RFS)
Time frame: Up to approximately 25 months after the last dose
Progression-free Survival (PFS)
Time frame: Up to approximately 25 months after the last dose
Event-free Survival (EFS)
Time frame: Up to approximately 25 months after the last dose
Duration of Remission/Response (DOR)
Time frame: Up to approximately 25 months after the last dose
Time to Remission/Response (TTR)
Time frame: Up to approximately 25 months after the last dose
Complete Remission Rate (CRR)
Time frame: Up to approximately 88 months
Time to Acute Myeloid Leukemia (AML) Transformation
Time frame: Up to approximately 88 months
Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10,
Time to Peak Plasma Concentration (Tmax)
Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24)
Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Terminal Phase Elimination Half-life (T1/2)
Time frame: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days
Total Body Clearance (CL)
Time frame: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days
Volume of Distribution (Vz)
Time frame: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days
Renal Clearance (CLr)
Time frame: Cycle 1 Day 1(C1D1). 1 cycle = 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33197925Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-90009 in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Celgene at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Spain, France, Norway, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicity (DLTs) (time frame: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02848001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.