NCT05413018

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
6mo left

Started Aug 2022

Typical duration for phase_2

Geographic Reach
1 country

34 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Aug 2022Oct 2026

First Submitted

Initial submission to the registry

May 25, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 19, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3.2 years

First QC Date

May 25, 2022

Last Update Submit

April 23, 2026

Conditions

Leukemia, Myeloid, Acute

Keywords

AzacitidineCC-486OnuregAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival (RFS)

    Up to 30 months

Secondary Outcomes (20)

  • Overall Survival (OS)

    Up to approximately 42 months

  • Time to relapse

    Up to approximately 30 months

  • Time to discontinuation of treatment

    Up to approximately 42 months

  • Number of participants with adverse events (AEs)

    Up to approximately 42 months

  • Number of participants with physical examination abnormalities

    Up to approximately 42 months

  • +15 more secondary outcomes

Study Arms (2)

CC-486/Oral Azacitidine Administration

EXPERIMENTAL
Drug: CC-486

Placebo Administration

PLACEBO COMPARATOR
Other: Placebo

Interventions

CC-486DRUG

Specified dose on specified days

Also known as: Azacitidine, Onureg
CC-486/Oral Azacitidine Administration
PlaceboOTHER

Specified dose on specified days

Placebo Administration

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML)
  • Eastern cooperative oncology group performance status of 0, 1, or 2
  • Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy
  • Must have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior to starting study therapy

You may not qualify if:

  • Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia
  • Candidate for allogeneic bone marrow or stem cell transplant at screening
  • Have achieved CR/CRi following therapy with hypomethylating agents
  • AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations
  • Proven central nervous system leukemia
  • Prior bone marrow or stem cell transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Local Institution - 0031

Hefei, Anhui, 230001, China

Location

Local Institution - 0013

Beijing, BJ, 100044, China

Location

Local Institution - 0027

Beijing, BJ, 100191, China

Location

Local Institution - 0028

Chongqing, CQ, 400000, China

Location

Local Institution - 0003

Guangzhou, GD, 510080, China

Location

Local Institution - 0008

Guangzhou, GD, 510080, China

Location

Local Institution - 0010

Shenzhen, GD, 518055, China

Location

Local Institution - 0002

Shijiazhuang, HE, 050000, China

Location

Local Institution - 0022

Xuzhou, Jiangsu, 221000, China

Location

Local Institution - 0005

Shenyang, Liaoning, 110001, China

Location

Local Institution - 0020

Shenyang, LN, 110022, China

Location

Local Institution - 0016

Chengdu, SC, 610041, China

Location

Local Institution - 0006

Shanghai, SH, 200025, China

Location

Local Institution - 0030

Xi'an, SN, 710100, China

Location

Local Institution - 0033

Taiyuan, SX, 030013, China

Location

Local Institution - 0001

Tianjin, TJ, 300020, China

Location

Local Institution - 0009

Ürümqi, Xinjiang, 830011, China

Location

Local Institution - 0007

Wenzhou, ZJ, 325015, China

Location

Local Institution - 0017

Changchun, 130021, China

Location

Local Institution - 0019

Changsha, 410008, China

Location

Local Institution - 0015

Changsha, 410013, China

Location

Local Institution - 0035

Ganzhou, 341000, China

Location

Local Institution - 0012

Guangzhou, 510060, China

Location

Local Institution - 0014

Hangzhou, 310009, China

Location

Local Institution - 0032

Harbin, 150086, China

Location

Local Institution - 0011

Jinan, 250012, China

Location

Local Institution - 0024

Kunming, 650032, China

Location

Local Institution - 0026

Lanzhou, 730030, China

Location

Local Institution - 0018

Nanchang, 330006, China

Location

Local Institution - 0029

Nanjing, 210029, China

Location

Local Institution - 0021

Suzhou, 215006, China

Location

Local Institution - 0023

Tianjin, 300052, China

Location

Local Institution - 0034

Zhangzhou, 363000, China

Location

Local Institution - 0004

Zhengzhou, 450008, China

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

cc-486Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 9, 2022

Study Start

August 19, 2022

Primary Completion

October 31, 2025

Study Completion (Estimated)

October 31, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

CN(34)