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

  • identifier


  • Recruitment Status


  • First Posted

    July 28, 2016

  • Last update posted

    July 22, 2021

Study Description

Brief 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 high-risk myelodysplastic syndrome.

  • Condition or Disease:Myelodysplastic Syndromes
    Leukemia, Myeloid, Acute
  • Intervention/Treatment: Drug: CC-90009
  • Phase: Phase 1

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 high-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 high-risk myelodysplastic syndrome.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 110 participants
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: November 2016
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: February 2022

Arms and interventions

Arm Intervention/treatment
Experimental: CC-90009 - Part A
Will be administered intravenously per dosing schedule in a 28-day cycle.
Drug: CC-90009
Experimental: CC-90009 - Part B - AML and MDS patients
Relapsed or refractory AML and MDS subjects. IP will be administered intravenously per dosing schedule determined in Part A
Drug: CC-90009

Outcome Measures

  • Primary Outcome Measures: 1. Dose- limiting toxicity (DLT) [ Time Frame: Up to 42 days ]
    Number of participants with a DLT
  • 2. Non-tolerated dose (NTD) [ Time Frame: Up to 42 days ]
    Dose level at which 2 or more of up to 6 evaluable subjects in any dose cohort experience a DLT in Cycle 1 during dose escalation.
  • 3. Maximum tolerated dose (MTD) [ Time Frame: Up to 42 days ]
    Last dose level(s) below the NTD with 0 or 1 out of 6 evaluable subjects experiencing a DLT in Cycle 1 during dose escalation
  • Secondary Outcome Measures: 1. Preliminary efficacy of CC-90009 [ Time Frame: Up to 2.5 years ]
    Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003)
  • 2. Preliminary efficacy of CC-90009 - AML [ Time Frame: Up to 2.5 years ]
    Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML.
  • 3. Pharmacokinetics-Cmax [ Time Frame: Up to Day 11 ]
    Maximum observed concentration in plasma
  • 4. Pharmacokinetics - AUC24 [ Time Frame: Up to Day 11 ]
    Area under the plasma concentration time-curve from time 0 to 24 hours
  • 5. Pharmacokinetics - tmax [ Time Frame: Up to Day 11 ]
    Time to peak (maximum) plasma concentration
  • 6. Pharmacokinetics - t 1/2 [ Time Frame: Up to Day 11 ]
    terminal half-life
  • 7. Pharmacokinetics - CL [ Time Frame: Up to Day 11 ]
    Total body clearance of the drug from plasma
  • 8. Pharmacokinetics - Vss [ Time Frame: Up to Day 11 ]
    Volume of distribution at steady-state
  • 9. Preliminary efficacy of CC-90009 - MDS [ Time Frame: Up to 2.5 years ]
    Determined by myelodysplastic syndrome (MDS) response rate based on the International Working Group (IWG) response criteria for Myelodysplasia.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


Inclusion Criteria: 1. Men and women ≥ 18 years of age, at the time of signing the ICD (Informed Consent Document). 2. Subject must understand and voluntarily sign an ICD prior to any study-related assessments/procedures being conducted. 3. Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory high-risk MDS (Myelodysplastic Syndrome) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies. 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2. 5. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion (DLI) without conditioning. 6. Subjects must have the following screening laboratory values: - Total White Blood Cell count (WBC) < 25 x 109/L prior to first infusion. Prior or concurrent treatment with hydroxyurea to achieve this level is 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. 7. Agree to follow the CC-90009 Pregnancy Prevention Plan (PPP) Exclusion Criteria: 1. Subjects with acute promyelocytic leukemia (APL) 2. 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. 3. 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). 4. Prior allogeneic hematopoietic stem cell transplant (HSCT) with either standard or reduced intensity conditioning ≤ 6 months prior to starting CC-90009. 5. Subjects on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted. 6. 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. 7. Leukapheresis ≤ 2 weeks prior to starting CC-90009. 8. For Part B, previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to C1D1. 9. For Part B, previous COVID-19 vaccine within 14 days of C1D1.

Contacts and Locations


Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:

Contact: First line of the email MUST contain NCT # and Site #.


United States, Connecticut
Yale Cancer Center
New Haven

United States, Illinois
Northwestern Memorial

United States, Massachusetts
Dana Farber Cancer Institute

United States, Missouri
Washington University Siteman Cancer Center
Saint Louis

United States, New Jersey
Hackensack University Medical Center

Canada, Ontario
Princess Margaret Hospital University Health Network

Institut Paoli Calmettes
Marseille Cedex 9

Hopital Lyon Sud
Pierre Benite

Institut Claudiu Regaud, IUCT-Oncopole

Haukeland University Hospital

Oslo University Hospital, Rikshospitalet HF

Hospital Germans Trias I Pujol

H Clinic I Provincial

MD Anderson Cancer Center - Madrid

Clinica Universidad de Navarra

Hospital Clinico Universitario de Salamanca

Hosptial La Fe

United Kingdom
Clatterbridge Cancer Centre - Liverpool

United Kingdom
The Churchill Hospital

Sponsors and Collaborators



Study Director: August Dietrich, MD Celgene

More Information

  • Responsible Party: Celgene
  • Identifier: NCT02848001 History of Changes
  • Other Study ID Numbers: CC-90009-AML-001, 2017-001535-39
  • First Posted: July 28, 2016 Key Record Dates
  • Last Update Posted: July 22, 2021
  • Last Verified: July 2021
  • Keywords provided by Celgene: MDS
    Myelodysplastic Syndrome
    Acute Myeloid Leukemia
    Hematologic Cancers
  • Additional relevant MeSH terms: Syndrome
    Myelodysplastic Syndromes
    Leukemia, Myeloid, Acute
    Leukemia, Myeloid