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A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

A Phase IB Multi-Arm Study With Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

NCT02670044•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological confirmation of relapsed or refractory AML after prior anti-leukemic therapy by WHO classification
•Ineligible for cytotoxic therapy defined by the following:
•a. Age (\>/=) 75 years or b. age 18- 74 years with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3 ii. Cardiac history of congestive heart failure requiring treatment or ejection fraction (\</=) 50% or chronic stable angina iii. Diffusing capacity of the lungs for carbon monoxide (\</=) 65% or forced expiratory volume in the first second of expiration (\</=) 65% iv. Creatinine clearance (\>/=) 30 mL/min to\< 45 mL/min v. any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Medical Monitor before screening and study enrollment.
•Life expectancy of at least 12 weeks
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
•Adequate liver and renal function

Exclusion Criteria

•Patients with acute promyelocytic leukemia (French-American-British \[FAB\] class M3 AML)
•Known active central nervous system (CNS) involvement with AML at study entry
•ECOG Performance Status (\>/=) 3 in patients who are (\>/=) 75 years old or ECOG Performance Status of 4, regardless of age
•Prior exposure to Bcl-2 inhibitors, murine double minute 2 (MDM2) antagonists or prior exposure to experimental treatment targeting Raf, mitogen-activated protein kinase (MEK), or the mitogen-activated protein kinase (MAPK) RAS/RAF/MEK/ERK MAPK pathway
•Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) and known history of HIV, malignancy, active infection and cardiovascular diseases (CVs)
•Received strong cytochrome (CYP) 3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers and moderate CYP3A inducers within 7 days prior to initiation of study treatment
•History of symptomatic Clostridium difficile infection within 1 month prior to dosing
•Dose Escalation Arm A (Venetoclax and Cobimetinib):
•History or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
•Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower
+5 more criteria

Locations (17)

USC Norris Cancer Center

Los Angeles, California, United States

UC Davis; Comprehensive Cancer Center

Sacramento, California, United States

Univ of Calif, San Francisco

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Weill Cornell Medical College

New York, New York, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Alberta Hospital

Edmonton, Alberta, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Key Dates

Start Date

March 9, 2016

Primary Completion Date

December 10, 2020

Completion Date

December 10, 2020

Last Updated

January 3, 2022

Enrollment

ACTUAL participants

Conditions

Leukemia, Myeloid, Acute

Interventions

Cobimetinib

DRUG

Idasanutlin

DRUG

Venetoclax

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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RECRUITING

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

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Leukemia, Myeloid, Acute

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RECRUITINGPHASE1

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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: January 3, 2022Data 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.

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A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Inclusion Criteria

Exclusion Criteria

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

Toxicity Genetic Determinants and Response to Azacitidine and Venetoclax in AML

A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome

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