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TERMINATEDPHASE1

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, 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

NCT02848001•Celgene

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (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.
•1. In Part A, R/R AML
•2. 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)
+17 more criteria

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).
•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.

Locations (20)

Stanford Cancer Center

Stanford, California, United States

Local Institution - 105

New Haven, Connecticut, United States

Local Institution - 102

Chicago, Illinois, United States

Local Institution - 103

Boston, Massachusetts, United States

Local Institution - 101

St Louis, Missouri, United States

Local Institution - 104

Hackensack, New Jersey, United States

Local Institution - 201

Toronto, Ontario, Canada

Local Institution - 505

Lillie Cedex, France

Institut Paoli Calmettes

Marseille, France

Hopital Lyon Sud

Pierre-Bénite, France

Key Dates

Start Date

November 14, 2016

Primary Completion Date

April 11, 2023

Completion Date

April 11, 2024

Last Updated

June 12, 2025

Enrollment

101

ACTUAL participants

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic Syndromes

Interventions

CC-90009

DRUG

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT06852222

Leukemia, Myeloid, Acute

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RECRUITINGPHASE1

Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS

NCT07270978

Acute Myeloid LeukemiaMyelodysplastic Syndromes+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

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