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Anti-metabolites
CC-486 + Venetoclax for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Daniel E Pollyea, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have confirmation of non-APL AML by WHO criteria46 and have undergone at least one line of therapy (dose escalation and dose expansion cohorts).
Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs for relapsed or refractory AML patients. The first part of the trial will determine the maximum tolerated dose of the new drugs. The second part will expand the trial to more patients using the maximum tolerated dose.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) who have already tried at least one treatment. They should expect to live at least 12 weeks, be able to perform daily activities with some limitations (ECOG ≤2), and have good kidney and liver function. Women must be postmenopausal or surgically sterile; men must agree to use contraception. Participants can't join if they have severe heart issues, uncontrolled infections, active CNS leukemia, HIV/hepatitis B/C infection, certain other cancers or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests a combination of two drugs: CC-486 (oral azacitidine) and Venetoclax in patients with relapsed/refractory AML. It's an open-label Phase I trial where everyone knows what treatment they're getting. The first part finds the maximum tolerated dose of CC-486 combined with Venetoclax; the second expands this dose in more patients.See study design
What are the potential side effects?
Potential side effects include digestive problems due to oral drug intake, risk of infections from immune system suppression by chemotherapy agents, possible liver dysfunction indicated by elevated enzymes like AST/ALT levels, fatigue from anemia or other blood disorders caused by bone marrow suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have AML (not APL type) confirmed by WHO criteria and have received at least one treatment.
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I am unable to have children due to surgery.
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I am over 60 and have not had a period for at least 12 months without other medical reasons.
Select...
My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the maximum tolerated dose of CC-486 in combination with venetoclax
Secondary outcome measures
Adverse event profile of CC-486 in combination with venetoclax
Side 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%
Productive cough
4%
Upper respiratory tract infection
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%
Blood glucose increased
1%
Hyponatraemia
1%
Abdominal wall abscess
1%
Hemiparesis
1%
Generalised tonic-clonic seizure
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
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Expansion CohortExperimental Treatment2 Interventions
CC-486 MTD will be determine following the completion of Cohort 1 and Cohort 2 with venetoclax at 400 mg/day PI regimen for 28 days.
Group II: Cohort 2 CC-486 300 mgExperimental Treatment2 Interventions
CC-486 300 mg will be administered orally on days 1-14 of a 28-day cycle. Venetoclax will be administered days 1-3, with the following schema: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3, and it will be continued at 400mg thereafter until day 28, the completion of cycle 1.
Group III: Cohort 1 CC-486 200 mgExperimental Treatment2 Interventions
CC-486 200 mg will be administered orally on days 1-14 of a 28-day cycle. Venetoclax will be administered days 1-3, with the following schema: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3, and it will be continued at 400mg thereafter until day 28, the completion of cycle 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-486
2015
Completed Phase 2
~630
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,442 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,504 Total Patients Enrolled
Daniel E Pollyea, MDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or have a strong reaction to azacitidine or mannitol.I do not have any major health issues unrelated to leukemia.I have had cancer before, but not the types excluded from this study.I have not had serious heart problems in the last 6 months.My white blood cell count is above 25 × 109/L.I have a type of skin cancer that is either basal cell or squamous cell.My breast or cervical cancer was treated while it was still localized.I have AML (not APL type) confirmed by WHO criteria and have received at least one treatment.I am unable to have children due to surgery.I am over 60 and have not had a period for at least 12 months without other medical reasons.I am a man who will use birth control during and up to 90 days after the study, unless I'm sterile or my partner cannot get pregnant.I am eligible for and agree to undergo intensive induction therapy.I will use birth control during and for 6 months after the study.I am eligible for a stem cell transplant and can have it during the study.I have a condition that affects how my body absorbs medicine taken by mouth.My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.My leukemia has spread to my brain or spinal cord.I can take care of myself and am up and about more than half of my waking hours.My prostate cancer is being managed with hormonal therapy alone.My liver is functioning well.I have an ongoing infection that hasn't improved with treatment.I am a woman who is not pregnant, not breastfeeding, and not able to become pregnant.My bilirubin levels are normal or slightly elevated, not due to leukemia.I had cancer before, but it was completely removed or treated to cure it.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 CC-486 200 mg
- Group 2: Cohort 2 CC-486 300 mg
- Group 3: Dose Expansion Cohort
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are senior citizens included as participants in this research?
"According to the requirements for this clinical trial, individuals aged 18 and older but not exceeding one hundred years of age are permitted to enroll."
Answered by AI
Is there an opportunity for me to partake in this research endeavor?
"Candidates for this trial should have been diagnosed with acute myelocytic leukemia and be between 18 to 100 years old. The study is currently recruiting 22 participants."
Answered by AI
How many participants are currently registered for this clinical trial?
"Affirmative, current information on clinicaltrials.gov implies that this experiment is currently enrolling patients. It was initially advertised on March 15th 2022 and most recently updated April 4th 2022; the research requires 22 individuals from 2 sites to participate."
Answered by AI
Are there still enrolment opportunities for this clinical trial?
"According to clinicaltrials.gov, this research trial is currently searching for enrolment and was first published on March 15th 2022 with a last update occurring on April 4th of the same year."
Answered by AI
Has CC-486 received endorsement from the U.S. Food and Drug Administration?
"Since this is an early-stage clinical trial, there is only minimal data to support the safety and efficacy of CC-486. Thus, we assign it a score of 1 on our scale from 1 to 3."
Answered by AI
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