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

NCT02848001 | Terminated Phase 1 Results

• 2 other identifiers: CC-90009-AML-0012017-001535-39
• Study Type: interventional
• Target: 101
• Locations: 6 countries
• Sites: 20

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 higher-risk myelodysplastic syndrome.

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Keywords

CC-90009; Hematologic Cancers; Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome; AML; MDS

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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)

  From first dose until 28 days post last dose (Up to 25 months)

• Change From Baseline by Laboratory Test - Chemistry Parameters 1

  From baseline until 28 days post last dose (Up to 25 months)

• Change From Baseline by Laboratory Test - Chemistry Parameters 2

  From baseline until 28 days post last dose (Up to 25 months)

Study Arms (2)

CC-90009 - Part A

EXPERIMENTAL

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

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

Drug: CC-90009

Interventions

CC-90009 DRUG

CC-90009

CC-90009 - Part A; CC-90009 - Part B - AML and MDS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (20)

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Local Institution - 105

New Haven, Connecticut, 06510, United States

Location

Local Institution - 102

Chicago, Illinois, 60611, United States

Location

Local Institution - 103

Boston, Massachusetts, 02115, United States

Location

Local Institution - 101

St Louis, Missouri, 63110, United States

Location

Local Institution - 104

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 201

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 505

Lillie Cedex, 59037, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Hopital Lyon Sud

Pierre-Bénite, 69310, France

Location

Local Institution - 502

Toulouse, 31059, France

Location

Local Institution - 700

Bergen, N-5053, Norway

Location

Local Institution - 701

Oslo, N-0027, Norway

Location

Local Institution - 603

Badalona, 8916, Spain

Location

Local Institution - 602

Barcelona, 08036, Spain

Location

Local Institution - 604

Madrid, 28033, Spain

Location

Local Institution - 605

Pamplona, 31008, Spain

Location

Local Institution - 601

Salamanca, 37007, Spain

Location

Local Institution - 600

Valencia, 46009, Spain

Location

Local Institution - 301

Oxford, 0X3 7LE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33197925 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia

Interventions

CC-90009

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: July 28, 2016
• Study Start: November 14, 2016
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-05

Locations

CA (1); FR (4); US (6); NO (2); ES (6); GB (1)