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NCT04887857 Clinical Trial

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

Leukemia, Myeloid, Acute Clinical Trial

— OMNIVERSE  

Official title:
A Phase 1B, Open-label, Global, Multicenter, Dose Determination Study to Evaluate Safety, Tolerability, and Preliminary Efficacy of CC-486 (ONUREG®) in Combination Therapy in Subjects With Acute Myeloid Leukemia (AML)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04887857
Other study ID # CC-486-AML-004
Secondary ID 2020-004941-35
Status Completed
Phase Phase 1
First received
Last updated
Start date December 1, 2021
Est. completion date January 8, 2024

Study information
Verified date February 2024
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date January 8, 2024
Est. primary completion date January 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmation of the following for Acute Myeloid Leukemia (AML) - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. ECOG 3 is allowed if participants are 18 to 74 years old with comorbidities - Agree to serial bone marrow aspirate/biopsies Exclusion Criteria: - Suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype - Received prior hypomethylating agent (HMA) therapy for myelodysplastic syndromes/Chronic myelomonocytic leukemia then develop AML within 4 months of discontinuing the HMA therapy - Prior history of malignancy unless the participant has been free of the disease for = 1 year prior to the start of study treatment Other protocol-defined inclusion/exclusion criteria apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CC-486
Specified dose on specified days
• Venetoclax
Specified dose on specified days

Locations
Country Name City State
Australia Local Institution - 201 Melbourne
Australia Local Institution - 202 North Melbourne Victoria
United States Local Institution - 105 Boston Massachusetts
United States Local Institution - 102 Cleveland Ohio
United States Local Institution - 110 Denver Colorado
United States Local Institution - 101 Houston Texas
United States Local Institution - 106 New York New York
United States Local Institution - 113 New York New York
United States Local Institution - 111 Oklahoma City Oklahoma
United States Local Institution - 104 Stanford California

Sponsors (2)
Lead Sponsor Collaborator
Celgene AbbVie

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) Up to 42 days after first dose
Primary Incidence of type of adverse events (AEs) From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary Incidence of frequency of AEs From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary Incidence of severity of AEs From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary Incidence of relationship of AEs to study treatment From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary Incidence of clinically significant changes in clinical laboratory results: Hematology tests From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests From informed consent form (ICF) signature to 28 days after last dose of study drug
Primary Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests From informed consent form (ICF) signature to 28 days after last dose of study drug
Secondary Rate of complete remission (CR)/complete remission with partial hematologic recovery (CRh) Up to approximately 12 months
Secondary Overall Response Rate (ORR) Up to approximately 12 months
Secondary Minimal Residual Disease (MRD) Response Rate Up to approximately 12 months
Secondary MRD Conversion Rate Up to approximately 12 months
Secondary Rate of complete remission (CR)/complete remission with incomplete recovery of blood counts (CRi) Up to approximately 12 months
See also
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Completed NCT01617226 - Randomised Study of Azacitidine Versus Azacitidine With Vorinostat in Patients With AML or High Risk MDS Phase 2
Terminated NCT00916045 - Pilot Study of Unrelated Cord Blood Transplantation Phase 2
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Completed NCT00640796 - Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors Phase 1
Completed NCT00458250 - Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H Phase 1
Active, not recruiting NCT05424380 - A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS Phase 1
Completed NCT01690624 - BI 836858 Dose Escalation in Patients With Refractory or Relapsed Acute Myeloid Leukemia and in Patients in Complete Remission With High Risk to Relapse Phase 1
Recruiting NCT05471700 - Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients Phase 1/Phase 2
Not yet recruiting NCT05016063 - Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia Early Phase 1
Not yet recruiting NCT04450784 - ObServatory Children Acute RElated Therapy Leukemia
Recruiting NCT04265963 - CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia Phase 1/Phase 2
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Recruiting NCT03793517 - Decitabine Plus mBU/CY for High Risk Acute Leukemia With MRD Pre-HSCT Phase 2/Phase 3
Terminated NCT02841540 - A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes Phase 1
Recruiting NCT05453903 - A Study of JNJ-75276617 in Combination With Acute Myeloid Leukemia (AML) Directed Therapies Phase 1
Completed NCT03720366 - A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients Phase 1
Withdrawn NCT04230564 - Acute Myeloid Leukemia Real World Treatment Patterns
Terminated NCT03761069 - Study of PTC299 (Emvododstat) in Relapsed/Refractory Acute Leukemias Phase 1

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