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Anti-metabolites
CC-486 + Venetoclax for Acute Myeloid Leukemia (OMNIVERSE Trial)
Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agree to serial bone marrow aspirate/biopsies
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 12 months
Awards & highlights
OMNIVERSE Trial Summary
This trial is testing a new drug combination to see if it is safe and effective for people with AML who have relapsed or who are refractory to other treatments.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) who can perform daily activities on their own or with some help. They must be able to undergo regular bone marrow tests. People with a certain type of AML, recent HMA therapy for other blood disorders, or another cancer within the last year cannot join.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: CC-486 (ONUREG®), an oral medication, and Venetoclax. It aims to see how safe they are together and if they work well in treating patients with relapsed/refractory AML or those newly diagnosed.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems, tiredness, and potential liver issues. Each patient's experience may vary.
OMNIVERSE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to have multiple bone marrow tests.
OMNIVERSE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
+5 moreSecondary outcome measures
MRD Conversion Rate
Minimal Residual Disease (MRD) Response Rate
Overall Response Rate (ORR)
+2 moreSide effects data
From 2023 Phase 2 trial • 240 Patients • NCT0225032657%
Nausea
53%
Vomiting
42%
Diarrhoea
41%
Constipation
34%
Decreased appetite
33%
Asthenia
32%
Alopecia
30%
Fatigue
24%
Peripheral sensory neuropathy
20%
Cough
20%
Dyspnoea
19%
Neutropenia
15%
Anaemia
15%
Oedema peripheral
14%
Arthralgia
13%
Pyrexia
13%
Paraesthesia
11%
Headache
11%
Weight decreased
11%
Myalgia
11%
Insomnia
10%
Stomatitis
10%
Dizziness
9%
Pulmonary embolism
9%
Abdominal pain
9%
Musculoskeletal pain
8%
Pleural effusion
8%
Dry skin
8%
Pain in extremity
6%
Muscle spasms
6%
Neutrophil count decreased
6%
Leukopenia
6%
Dyspepsia
6%
Pneumonia
6%
Nasopharyngitis
6%
Oral candidiasis
6%
Anxiety
5%
Haemorrhoids
5%
Back pain
5%
General physical health deterioration
5%
Vision blurred
5%
Haemoptysis
5%
Vertigo
5%
Muscular weakness
4%
Upper respiratory tract infection
4%
Productive cough
4%
Abdominal pain upper
4%
Non-cardiac chest pain
4%
Epistaxis
4%
Musculoskeletal chest pain
4%
Hypophosphataemia
3%
Urinary tract infection
3%
Rhinorrhoea
3%
Hypomagnesaemia
3%
Alanine aminotransferase increased
3%
Performance status decreased
3%
Respiratory tract infection
3%
Bronchitis
3%
Hypotension
3%
Cancer pain
1%
Lower respiratory tract infection
1%
Abdominal wall abscess
1%
Hemiparesis
1%
Generalised tonic-clonic seizure
1%
Blood glucose increased
1%
Hyponatraemia
1%
Paraparesis
1%
Intestinal obstruction
1%
Confusional state
1%
Acute kidney injury
1%
Haematuria
1%
Acute respiratory distress syndrome
1%
Interstitial lung disease
1%
Flushing
1%
Circulatory collapse
1%
Influenza
1%
Febrile neutropenia
1%
Metastases to meninges
1%
Flatulence
1%
Urinary tract obstruction
1%
Respiratory distress
1%
Pneumonia pneumococcal
1%
Sudden death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nab-Paclitaxel + CC-486 Combination Arm
Nab-Paclitaxel + Durvalumab Combination Arm
Nab-Paclitaxel Monotherapy Arm
OMNIVERSE Trial Design
1Treatment groups
Experimental Treatment
Group I: CC-486 in combination with VenetoclaxExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
CC-486
2015
Completed Phase 2
~630
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,965 Total Patients Enrolled
AbbVieIndustry Sponsor
954 Previous Clinical Trials
501,099 Total Patients Enrolled
Kimberley Dilley, MD/MPHStudy DirectorCelgene Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have AML and can care for myself, or if I'm less able, I'm between 18-74 years old with other health issues.I agree to have multiple bone marrow tests.I can care for myself and am mostly active, but may be fully active or unable to work.I am diagnosed or suspected to have a specific type of leukemia.I developed AML within 4 months after stopping treatment for myelodysplastic syndromes or CMML with an HMA.I have been cancer-free for at least 1 year before starting this study.My condition is confirmed as Acute Myeloid Leukemia (AML).
Research Study Groups:
This trial has the following groups:- Group 1: CC-486 in combination with Venetoclax
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research project have a wide geographical footprint?
"9 different hospitals are currently recruiting patients for this trial. If you are considering enrolling, please choose the hospital nearest to your location to minimize travel. The hospitals recruiting patients are located in Houston, New york, Stanford, and 6 other cities."
Answered by AI
Does CC-486 have a long history of being trialed in other medical studies?
"In 2006, the first study on CC-486 was conducted at Chinese University of Hong Kong-Prince of Wales Hospital. As of now, there have been a total of 208 completed studies on the topic. Additionally, there are 350 active studies recruiting patients. A large portion of these studies are taking place in Houston, Texas."
Answered by AI
Does CC-486 have any dangerous side effects for people?
"CC-486 scored a 1 on our team's safety scale at Power. This is due to CC-486 being in Phase 1 trials, meaning that there is limited data to support both its safety and efficacy."
Answered by AI
What are the primary conditions that CC-486 is designed to improve?
"CC-486 is a medication used to treat leukemia, anemias, and myelocytic. It can also be used to help with multilineage dysplasia and acute conditions."
Answered by AI
Are research participants still being sought for this trial?
"The information available on clinicaltrials.gov verifies that this trial is still looking for participants. The trial was originally posted on December first 2021 and was updated on October 31st, 2022. So far, 66 patients have been recruited from 9 different sites."
Answered by AI
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