AMLPhase 1NCT05287568
CC-486 and Venetoclax for Acute Myeloid Leukemia
A Phase 1 study testing Venetoclax and CC-486 in people with AML, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- AML
- What is being tested?
- Venetoclax and CC-486
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2022to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 R/R cohorts), or have had no prior lines of therapy (newly diagnosed cohort) Prior treatment with hydroxyurea or ATRA is allowed in the newly diagnosed cohort.
- For the newly diagnosed cohort, subjects must be unlikely to tolerate standard intensive chemotherapy due to age, performance status, or comorbidities based on at least one of the following criteria:
- age ≥75 years old OR b. age < 75 years old with at least one of the following: i. ECOG performance status of 3 ii. Cardiac history of CHF or documented EF ≤50% iii. pulmonary disease with DLCO ≤65% or FEV1 ≤65% iv. creatinine clearance ≥30 mL/min to < 45 mL/min based on the CKD-EPI Creatinine Equation (2021). https://www.kidney.org/content/ckd-epi-creatinine-equation-2021 v. any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy
- Patients must have ECOG of 0 to 3 (if < 75 years old) or 0 to 2 (if ≥75 years old)
- Transplant eligible patients can participate in the study and they are allowed to proceed with stem cell transplantation at any time during the study.
- Subject must have a projected life expectancy of at least 12 weeks.
Show all 18Show fewer
- Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
- Subject must have adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) ≤ 3.0 × ULN*
- alanine aminotransferase (ALT) ≤ 3.0 × ULN*
- bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome* * Unless considered due to leukemic organ involvement
- Non-sterile male subjects must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of study drug. No contraception is required if male subjects are surgically sterile (vasectomy with medical assessment confirming surgical success) or if the male subject has a female partner who is postmenopausal or permanently sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Female subjects must be either:
- Postmenopausal; defined as Age > 60 years with no menses for 12 or more months without an alternative medical cause; OR
- Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR
- If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose.
- Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed screening or procedures.
- Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit.
Who cannot join
- Subject has known active CNS involvement from AML.
- Subject is known to be positive for HIV. HIV testing is not required.
- Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV (i.e., HBs Ag, anti-HBs+ and anti-HBc-) may participate.
- Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
- Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure > class 2, unstable angina, or myocardial infarction.
- Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
Show all 17Show fewer
- Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
- Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.
- Subject has a history of other malignancies prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the breast or cervix uteri
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
- Prostate cancer not requiring therapy beyond hormonal therapy
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
- Subject has a white blood cell count > 25 × 109/L. Note: hydroxyurea or apheresis are permitted to meet this criterion.
- Any subject who is a candidate for intensive induction therapy and agrees to receive this therapy.
- Pregnant or breast-feeding females. A pregnancy test will be obtained at the time of screening.
- Known or suspected hypersensitivity to azacitidine or mannitol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
CU Anschutz Medical Campus
Aurora, Colorado, 80045
Derek Schatz, derek.schatz@cuanschutz.edu
Constance Brecl, 3035078221, constance.brecl@cuanschutz.edu
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Derek Schatz, derek.schatz@cuanschutz.edu
Constance Brecl, constance.brecl@cuanschutz.edu
About this study
This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.
Read the detailed description
Subjects confirmed eligible will be admitted to the hospital for cycle 1, day 1. 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.
Subjects taking concomitant CYP3A4 inhibitors will be given the appropriate reduced doses of venetoclax.
Subjects will be monitored inpatient for tumor lysis syndrome (TLS) for at least 24 hours after administration of the venetoclax target dose. Venetoclax will continue at 400 mg daily until day 28, the completion of cycle 1.
During dose escalation, subjects will be accrued into two cohorts using two different doses of CC-486 (cohort 1=200 mg, cohort 2=300 mg, both to be administered orally on days 1-14 of a 28-day cycle).
Two bone marrow biopsies will be performed during the first cycle: day 4 or 5 (+2 days), and day 28. The day 28 bone marrow will be used for efficacy purposes. Subsequent cycles will have response assessment bone marrow biopsies day 28 of every cycle for subjects who have not responded (CR/CRi/MLFS); after a response occurs (CR/CRi/MLFS), subjects will have bone marrow biopsies on day 28 of every 3rd cycle until they have been on the study for one year, at which point they will have a bone marrow biopsy every 6 months until study discontinuation.
Once the MTD is established, or in the absence of an MTD, a recommendation for a CC-486 dose with venetoclax is made, the study will progress to the expansion phase. For the expansion phase, 10 subjects will be recruited. These will be patients with relapsed/refractory (R/R) disease who have never received venetoclax. On day 1 of cycle 1, subjects will receive CC-486 at the MTD or recommended CC-486 dose as determined from Phase I, and this will continue daily through day 14. Venetoclax will be dose escalated, as above, from 100 to 200 to 400 mg on days 1, 2 and 3, respectively, with inpatient monitoring for TLS, and with appropriate dose reduction if administered with a CYP3A4 inhibitor. Bone marrow biopsies will occur on day 4 or 5 (+2) and on day 28 of cycle 1. Subsequent response assessment bone marrow biopsies will occur on day 28 of every 3rd cycle for subjects who have achieved a response for 1 year from study entry and then every 6 months until study discontinuation, or on day 28 of every treatment cycle for subjects who do not achieve a response.
- Conditions
- AML
- Being tested
- Venetoclax, CC-486
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, Abbvie
Venetoclax is a potent, selective and orally bioavailable small molecule inhibitor of BCL-2 that binds with > 1,000-fold higher affinity to BCL-2 (Ki < 0.010 nM) than other apoptotic pathway proteins BCL-XL (Ki = 48 nm) or MCL-1 (Ki > 444 nM). Leukemia stem cells (LSCs) overexpress BCL-2, and BCL-2 overexpression has been associated with worse outcomes in AML.
CC-486Drug
An oral formulation of azacitidine currently being developed for the treatment of hematological and solid malignancies.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 CC-486 200 mg | Experimental | 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. Receives: Drug: Venetoclax; Drug: CC-486 |
| Cohort 2 CC-486 300 mg | Experimental | 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. Receives: Drug: Venetoclax; Drug: CC-486 |
| Dose Expansion Cohort | Experimental | 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. Receives: Drug: Venetoclax; Drug: CC-486 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of CC-486 in combination with venetoclax
Standard phase I 3+3 design. The first 3 subjects will be assigned to cohort 1. If none of the first three subjects' experiences DLT, escalation to cohort 2 is permitted. If one of the first three subjects' experiences DLT, a total of six subjects will be required in that dose cohort, and escalation will only be permitted if five of six subjects do not experience DLT. If more than one DLT is observed in the second cohort, this will be determined to be the maximally administered dose, and three more subjects will be enrolled in the first cohort if only three were previously treated at that dose. The MTD will be the cohort in which ≤1/6 subjects have dose limiting toxicity at the dose prior to the maximally administered dose. If the second cohort has ≤1/6 subjects with a DLT, the MTD will not have been reached, and the recommended dose for the expansion cohorts will be determined based on the safety, efficacy and pharmacodynamic outcomes from subjects treated in the first two cohorts.
Measured: 7 years
Secondary outcomes (4)
Adverse event profile of CC-486 in combination with venetoclax
Subject safety will be assessed by reviewing AEs during planned and unplanned visits and physical and laboratory examinations from the time subject receives the first dose of study drug until safety follow up. AEs related to a procedure after consent will also be assessed. The investigator will assess and record AEs in detail including the date of onset, event diagnosis (if known) or sign/symptom, severity, time course (end date, ongoing, intermittent), relationship of the AE to the study drug, and any action taken. For SAEs considered unrelated to study drug, the investigator will provide another cause for the event. AEs may be recorded as the result of a response to a query, an observation by site personnel, or due to a report from a subject. All AEs will be followed to a satisfactory conclusion.
Measured: 7 years
Response Rate
Response rate, with responses defined as complete remission (CR), CR with incomplete blood count recovery (CRi) and morphologic leukemia free state (MLFS) for newly diagnosed and relapsed and refractory patients
Measured: 5 - 7 years
Time to Response
Time to response for newly diagnosed and relapsed and refractory patients
Measured: 5-7 Years
Response Duration
Response duration for newly diagnosed and relapsed and refractory patients
Measured: 5-7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start19 Dec 2022
- Primary completion23 Mar 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is an open label, dose escalation phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Daniel E Pollyea, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287568
- Sponsor's protocol ID
- 20-1319.cc
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual patient data.
Publications
Amaya ML, Abbott D, McMahon CM, Schwartz MS, Gutman JA, Kent A, Angelos MG, Sohalski C, Belachew A, Dell-Martin J, Anttila K, Stevens BM, D'Alessandro A, Showers WM, Gillen AE, Jordan CT, Pollyea DA. A Phase 1/1b Study of the All-Oral Regimen CC-486 and Venetoclax in Acute Myeloid Leukemia. Blood Adv. 2026 Jul 24:bloodadvances.2026020179. doi: 10.1182/bloodadvances.2026020179. Online ahead of print.
PubMed 42498285
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CC-486 and Venetoclax for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05287568
- Acronym / sponsor ID
- 20-1319.cc
- Conditions
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, dose escalation Phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.
Detailed description
Subjects confirmed eligible will be admitted to the hospital for cycle 1, day 1. 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.
Subjects taking concomitant CYP3A4 inhibitors will be given the appropriate reduced doses of venetoclax.
Subjects will be monitored inpatient for tumor lysis syndrome (TLS) for at least 24 hours after administration of the venetoclax target dose. Venetoclax will continue at 400 mg daily until day 28, the completion of cycle 1.
During dose escalation, subjects will be accrued into two cohorts using two different doses of CC-486 (cohort 1=200 mg, cohort 2=300 mg, both to be administered orally on days 1-14 of a 28-day cycle).
Two bone marrow biopsies will be performed during the first cycle: day 4 or 5 (+2 days), and day 28. The day 28 bone marrow will be used for efficacy purposes. Subsequent cycles will have response assessment bone marrow biopsies day 28 of every cycle for subjects who have not responded (CR/CRi/MLFS); after a response occurs (CR/CRi/MLFS), subjects will have bone marrow biopsies on day 28 of every 3rd cycle until they have been on the study for one year, at which point they will have a bone marrow biopsy every 6 months until study discontinuation.
Once the MTD is established, or in the absence of an MTD, a recommendation for a CC-486 dose with venetoclax is made, the study will progress to the expansion phase. For the expansion phase, 10 subjects will be recruited. These will be patients with relapsed/refractory (R/R) disease who have never received venetoclax. On day 1 of cycle 1, subjects will receive CC-486 at the MTD or recommended CC-486 dose as determined from Phase I, and this will continue daily through day 14. Venetoclax will be dose escalated, as above, from 100 to 200 to 400 mg on days 1, 2 and 3, respectively, with inpatient monitoring for TLS, and with appropriate dose reduction if administered with a CYP3A4 inhibitor. Bone marrow biopsies will occur on day 4 or 5 (+2) and on day 28 of cycle 1. Subsequent response assessment bone marrow biopsies will occur on day 28 of every 3rd cycle for subjects who have achieved a response for 1 year from study entry and then every 6 months until study discontinuation, or on day 28 of every treatment cycle for subjects who do not achieve a response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open label, dose escalation phase I single institution pilot study for relapsed and refractory AML patients using CC-486 (oral azacitidine) with venetoclax. At the completion of dose escalation and after establishment of the MTD or recommended dose of CC-486 with venetoclax, an expansion phase will commence, using venetoclax with the MTD of CC-486 in relapsed/refractory patients.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 CC-486 200 mg | Experimental | Drug: Venetoclax, Drug: CC-486CC-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. |
| Cohort 2 CC-486 300 mg | Experimental | Drug: Venetoclax, Drug: CC-486CC-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. |
| Dose Expansion Cohort | Experimental | Drug: Venetoclax, Drug: CC-486CC-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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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 R/R cohorts), or have had no prior lines of therapy (newly diagnosed cohort) Prior treatment with hydroxyurea or ATRA is allowed in the newly diagnosed cohort.
- For the newly diagnosed cohort, subjects must be unlikely to tolerate standard intensive chemotherapy due to age, performance status, or comorbidities based on at least one of the following criteria:
- Patients must have ECOG of 0 to 3 (if < 75 years old) or 0 to 2 (if ≥75 years old)
- Transplant eligible patients can participate in the study and they are allowed to proceed with stem cell transplantation at any time during the study.
- Subject must have a projected life expectancy of at least 12 weeks.
Key exclusion criteria (17 listed)
- Subject has known active CNS involvement from AML.
- Subject is known to be positive for HIV. HIV testing is not required.
- Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV (i.e., HBs Ag, anti-HBs+ and anti-HBc-) may participate.
- Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
- Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenetoclaxAlso: ABT-199, AbbvieVenetoclax is a potent, selective and orally bioavailable small molecule inhibitor of BCL-2 that binds with > 1,000-fold higher affinity to BCL-2 (Ki < 0.010 nM) than other apoptotic pathway proteins BCL-XL (Ki = 48 nm) or MCL-1 (Ki > 444 nM). Leukemia stem cells (LSCs) overexpress BCL-2, and BCL-2 overexpression has been associated with worse outcomes in AML. | Drug | Cohort 1 CC-486 200 mg, Cohort 2 CC-486 300 mg, Dose Expansion Cohort |
| CC-486An oral formulation of azacitidine currently being developed for the treatment of hematological and solid malignancies. | Drug | Cohort 1 CC-486 200 mg, Cohort 2 CC-486 300 mg, Dose Expansion Cohort |
Primary outcome
Determine the maximum tolerated dose of CC-486 in combination with venetoclax
Time frame: 7 years
Standard phase I 3+3 design. The first 3 subjects will be assigned to cohort 1. If none of the first three subjects' experiences DLT, escalation to cohort 2 is permitted. If one of the first three subjects' experiences DLT, a total of six subjects will be required in that dose cohort, and escalation will only be permitted if five of six subjects do not experience DLT. If more than one DLT is observed in the second cohort, this will be determined to be the maximally administered dose, and three more subjects will be enrolled in the first cohort if only three were previously treated at that dose. The MTD will be the cohort in which ≤1/6 subjects have dose limiting toxicity at the dose prior to the maximally administered dose. If the second cohort has ≤1/6 subjects with a DLT, the MTD will not have been reached, and the recommended dose for the expansion cohorts will be determined based on the safety, efficacy and pharmacodynamic outcomes from subjects treated in the first two cohorts.
4 secondary outcomes
Adverse event profile of CC-486 in combination with venetoclax
Time frame: 7 years
Response Rate
Time frame: 5 - 7 years
Time to Response
Time frame: 5-7 Years
Response Duration
Time frame: 5-7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 42498285Amaya ML, Abbott D, McMahon CM, Schwartz MS, Gutman JA, Kent A, Angelos MG, Sohalski C, Belachew A, Dell-Martin J, Anttila K, Stevens BM, D'Alessandro A, Showers WM, Gillen AE, Jordan CT, Pollyea DA. A Phase 1/1b Study of the All-Oral Regimen CC-486 and Venetoclax in Acute Myeloid Leukemia. Blood Adv. 2026 Jul 24:bloodadvances.2026020179. doi: 10.1182/bloodadvances.2026020179. Online ahead of print.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual patient data.
Related trials for AML
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel E Pollyea, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Venetoclax and CC-486 in people with AML, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Derek Schatz (7208480628, derek.schatz@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose of CC-486 in combination with venetoclax (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.