Myeloid MalignancyPhase 1/2NCT06129734
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
A Phase 1/2 study testing Venetoclax and Decitabine in people with Myeloid Malignancy and Acute Myeloid Leukemia, run by Benjamin Tomlinson at 2 sites in United States.
Trial summary
The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Malignancy, Acute Myeloid Leukemia
- What is being tested?
- Venetoclax and Decitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jul 2025to Sep 2027
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Acute myeloid leukemia, MDS, MDS/AML who requires and allogeneic stem cell transplant.
- For AML and MDS/AML, bone marrow myeloblasts <5% at pre-transplant bone marrow sample with no circulating blasts. For MDS patients, pre-transplant bone marrow myeloblasts < 10%
- Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD/MUD/Haplo/UCB) is permitted.
- Participants must be 18 years of age or older.
- Total bilirubin < 2.0 mg/dL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin < 2 × ULN).
- Creatinine clearance (CrCl) > 30 ml/min.
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- ECOG 0-1 or KPS equal or greater than 70 performance status
- Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures.
- Patients may enroll prior to or after allo SCT. Patients should enroll no later than post transplant day 40, and the the following post-Allo HSCT inclusion criteria must be met in order to initiate the maintenance study treatment:
- Successful engraftment defined by absolute neutrophil count (ANC) of ≥500/ul and platelet count of ≥50,000/uL sustained for at least three consecutive days
- These criteria for engraftment should be met on or before Day +50.
- No active infection
- No GVHD ≥ overall grade II (Grade 1 GVHD of the skin acceptable).
- Participants must continue to meet additional inclusion criteria
- <5% myeloblasts in a bone marrow aspirate with spicules, that is to be obtained, if all the above inclusion criteria are satisfied.
Who cannot join
- Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician
- Currently pregnant or breast-feeding. Females of childbearing (FOCBP) potential must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months (therefore not naturally post-menopausal for > 12 months)
- Uncontrolled comorbid illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:
- Active infection
- Uncontrolled concurrent malignancy
- Congestive heart failure of NYHA class III/IV. Participants with compensated heart failure are permitted.
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- Unstable angina pectoris
- New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted
- Decompensated liver cirrhosis (Child-Pugh score ≥12 or a MELD score ≥21
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the participants or impair the assessment of study results.
- FOCBP and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, they should inform the treating physician immediately
- Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of decitabine/venetoclax.
- Participants with known active HIV infection, as this will further increase the risk for opportunistic infections. However, participants with chronic HIV with undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of antiretroviral therapy would be eligible.
- Known allergy or hypersensitivity to any component of decitabine/venetoclax
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
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Benjamin Tomlinson, MD, 216-844-0139, benjamin.tomlinson@uhhospitals.org
Claudio Brunstein, MD
- Recruiting
University Hospitals Seidman Cancer, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Benjamin Tomlinson, MD, Benjamin.tomlinson@uhhospitals.org
About this study
Official title: Phase 1B/2A Study of Weekly Decitabine and Venetoclax Treatment as Maintenance Therapy in High-Risk Myeloid Malignancy Patients Post Allograft Stem Cell Transplant
The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.
Read the detailed description
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While 60-80% patients can achieve remission, a high rate of relapse mandates consolidative treatment. Unfortunately, 40% of AML patients and 30% of myelodysplastic syndrome patients will relapse after alloSCT, and those who relapse after transplant exhibit poor outcomes. As such, prevention of post-transplant relapse remains a key interest. Maintenance therapy with low-intensity chemotherapy and/or targeted therapy is one strategy that holds promise to reduce post-transplant relapse, controlling residual subclinical disease before frank relapse. As post-transplant maintenance strategies yield mixed results, standard of care maintenance therapy remains an unmet clinical need.
The combination of hypomethylating agents (HMAs), such as decitabine or 5-azacytidine, and the B-cell lymphoma 2 (BCL2) inhibitor venetoclax combination has transformed the management of transplant-ineligible AML patient improving median overall survival (OS) to 14.7 months compared to 9.6 months with azacytidine and placebo at the cost of more pronounced cytopenias (Grade 3 and 4 thrombocytopenia and neutropenia occurring in 45%/38% and 42%/28% respectively).
Recent work has demonstrated a mechanism by which HMAs cooperate with venetoclax, via priming AML cells for death via the integrated stress response (ISR). The ISR transcription factor activating transcription factor-4 (ATF4) is upregulated in a matter of hours after HMA treatment, and in turn activates Phorbol-12-myristate-13-acetate-induced protein 1 (PMAIP1) (NOXA) that degrades the BCL2-family member myeloid cell leukemia sequence 1 (MCL1), thus creating greater dependence in HMA-exposed malignant cells on BCL2 to avoid BAX/BAK mediated mitochondrial outer membrane permeabilization (MOMP), caspase release, and subsequent apoptosis. An irreversible step toward apoptosis is mitochondrial outer membrane permeabilization (MOMP) by BAX/BAK oligomers, which releases caspase proteases into the cells, a commitment into apoptosis that is fundamentally counteracted by BCL2-family antiapoptotic proteins, e.g., BCL2, the target of venetoclax inhibition. This mechanism primes AML blasts for venetoclax-mediated toxicity.
Through rigorous pharmacological optimization, it has been shown that the decitabine 5 mg/m2 weekly with a single dose of venetoclax 6 hours after the decitabine can control disease with limited effects normal hematopoietic cells.9 This novel dosing regimen may maximize decitabine/venetoclax anti-leukemic activity while minimizing hematologic toxicity and represents an attractive regimen for post-alloSCT maintenance therapy.
- Conditions
- Myeloid Malignancy, Acute Myeloid Leukemia
- Being tested
- Venetoclax, Decitabine
- Keywords
- Allograft Stem Cell Transplant
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Venetoclax is a BCL2 inhibitor. It is administered at low doses and used in combination with other hypomethylating agents such as decitabine to manage participants with acute myeloid lymphoma who have undergone stem cell transplant. Participants will initiate therapy with decitabine that will be followed by venetoclax 400 mg oral 6-8 hours later. Participants will continue this dose each week. The venetoclax dose will be reduced to 100 mg once per week if the participant is being treated with posaconazole or voriconazole (strong CYP3A4 inhibitors) (considered dose equivalent to venetoclax 400 mg 1X/week). The venetoclax dose will be reduced 200 mg once per week if the participant is being treated with fluconazole or isavuconazole (moderate CYP3A4 inhibitors) (considered dose equivalent to venetoclax 400 mg 1X/week). This clinical trial is administering venetoclax well below the current FDA approved dosing.
DecitabineDrug
Decitabine is a hypomethylating agent. It is administered at low doses and used in combination with venetoclax to manage participants with acute myeloid lymphoma who have undergone stem cell transplant. Participants initiate therapy with 5 mg/m2 decitabine subcutaneous every week followed by venetoclax.
| Study group | Role | What they receive |
|---|---|---|
| Low dose maintenance chemotherapy | Experimental | Participants will receive low dose chemotherapy as a maintenance therapy post-transplant. Participants must enroll by post-transplant day 40. Treatment will consist of once weekly 5 mg/m2 decitabine followed by 400 mg venetoclax orally approximately 6 hours afterwards. Participants will continue maintenance therapy for one year or unacceptable toxicity. Participants will otherwise receive post Allogeneic hematopoietic stem cell transplant (alloSCT) care and disease monitoring as per institutional standards. Receives: Drug: Venetoclax; Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by dose limiting toxicities
The primary objective of this study will be to assess the safety of low dose decitabine/venetoclax in the post transplant setting. Safety will be defined in accordance with FDA guidance on development for new therapeutics in AML with the particular criteria to be considered as DLTs.
The stopping criteria are described for the incidence of dose limiting toxicities that are at least possibly related to the study treatment.
Using Bayesian toxicity monitoring with maximum DLT probability as 0.15, prior distribution (0.5, 0.5), maximum participants 20, minimum number of participants before stopping 9, cohort size 5, and posterior probability 0.8, the study will be paused for review if (2, 3, 4, 5) or more participants experiencing such Grade 4 events in (69, 11, 16, 20) participants, respectively.
Measured: 1 year after treatment
Feasibility as measured by the rate of participants receiving planned treatment
The primary objective of this study will be to assess the feasibility of low dose decitabine/venetoclax in the post transplant setting. Feasibility will be defined as ≥ 80% of participants receiving ≥80% of planned decitabine/venetoclax doses, excluding participants removed from the study in the event of relapse.
Measured: 1 year after treatment
Secondary outcomes (1)
Rate of relapse free survival
The secondary objective is to determine the effects of low dose decitabine/venetoclax on the one relapse free survival compared to CIBMTR historical Disease Risk Index (DRI) data. The CIBMTR Disease Risk Index (DRI) is a clinically validated tool to predict survival post-transplant survival.
Relapse-free survival (RFS) is measured from the date of the stem cell infusion to the date of disease progression or the date of death, whichever occurs first; and is censored at the date of last followed for those alive without disease progression. Relapse will be defined as more than 5% blasts on bone marrow biopsy, or, in the case of myelodysplastic syndrome (MDS), any clinical change that in the treating physician's opinion triggers change in therapy and will be compared to historical CIBMTR controls for very high or high risk for relapse by CIBMTR Disease Risk Index (DRI).
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start28 Jul 2025
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid MalignancyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamin Tomlinson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin Tomlinson, Case Comprehensive Cancer Center
- Investigators
- Benjamin Tomlinson, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterJames Ignatz-Hoover, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClaudio Brunstein, MD, PhD, Principal investigator, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129734
- Sponsor's protocol ID
- CASE2923
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant data that underlie or influence the results observed from the study
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B/2A Study of Weekly Decitabine and Venetoclax Treatment as Maintenance Therapy in High-Risk Myeloid Malignancy Patients Post Allograft Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT06129734
- Acronym / sponsor ID
- CASE2923
- Conditions
- Myeloid Malignancy, Acute Myeloid Leukemia
- Keywords
- Allograft Stem Cell Transplant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Benjamin TomlinsonUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Nov 2023 (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.
The goal of this interventional clinical trial is to determine if low doses of gentle chemotherapy after bone marrow transplant may prevent relapse and promote an increase in survival and decrease in side effects in participants with acute myeloid leukemia and myelodysplastic syndromes. The main question it aims to answer is whether or not providing a new, gentler way of administering chemotherapy will help control leftover cancer with minimal side effects. This treatment involves decitabine and venetoclax. Participants will receive standard post-transplant care. Participants will be administered decitabine once per week with normal transplant follow up visits, and then will take a venetoclax pill about 6 to 8 hours later. Participants will meet their study team at the beginning, midway, and at the end of the trial to receive bone marrow testing. Participants will receive treatment until either one year of therapy, relapse, or recurrent dose limiting toxicity (DLT) despite dose reduction.
Detailed description
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While 60-80% patients can achieve remission, a high rate of relapse mandates consolidative treatment. Unfortunately, 40% of AML patients and 30% of myelodysplastic syndrome patients will relapse after alloSCT, and those who relapse after transplant exhibit poor outcomes. As such, prevention of post-transplant relapse remains a key interest. Maintenance therapy with low-intensity chemotherapy and/or targeted therapy is one strategy that holds promise to reduce post-transplant relapse, controlling residual subclinical disease before frank relapse. As post-transplant maintenance strategies yield mixed results, standard of care maintenance therapy remains an unmet clinical need.
The combination of hypomethylating agents (HMAs), such as decitabine or 5-azacytidine, and the B-cell lymphoma 2 (BCL2) inhibitor venetoclax combination has transformed the management of transplant-ineligible AML patient improving median overall survival (OS) to 14.7 months compared to 9.6 months with azacytidine and placebo at the cost of more pronounced cytopenias (Grade 3 and 4 thrombocytopenia and neutropenia occurring in 45%/38% and 42%/28% respectively).
Recent work has demonstrated a mechanism by which HMAs cooperate with venetoclax, via priming AML cells for death via the integrated stress response (ISR). The ISR transcription factor activating transcription factor-4 (ATF4) is upregulated in a matter of hours after HMA treatment, and in turn activates Phorbol-12-myristate-13-acetate-induced protein 1 (PMAIP1) (NOXA) that degrades the BCL2-family member myeloid cell leukemia sequence 1 (MCL1), thus creating greater dependence in HMA-exposed malignant cells on BCL2 to avoid BAX/BAK mediated mitochondrial outer membrane permeabilization (MOMP), caspase release, and subsequent apoptosis. An irreversible step toward apoptosis is mitochondrial outer membrane permeabilization (MOMP) by BAX/BAK oligomers, which releases caspase proteases into the cells, a commitment into apoptosis that is fundamentally counteracted by BCL2-family antiapoptotic proteins, e.g., BCL2, the target of venetoclax inhibition. This mechanism primes AML blasts for venetoclax-mediated toxicity.
Through rigorous pharmacological optimization, it has been shown that the decitabine 5 mg/m2 weekly with a single dose of venetoclax 6 hours after the decitabine can control disease with limited effects normal hematopoietic cells.9 This novel dosing regimen may maximize decitabine/venetoclax anti-leukemic activity while minimizing hematologic toxicity and represents an attractive regimen for post-alloSCT maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose maintenance chemotherapy | Experimental | Drug: Venetoclax, Drug: DecitabineParticipants will receive low dose chemotherapy as a maintenance therapy post-transplant. Participants must enroll by post-transplant day 40. Treatment will consist of once weekly 5 mg/m2 decitabine followed by 400 mg venetoclax orally approximately 6 hours afterwards. Participants will continue maintenance therapy for one year or unacceptable toxicity. Participants will otherwise receive post Allogeneic hematopoietic stem cell transplant (alloSCT) care and disease monitoring as per institutional standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of Acute myeloid leukemia, MDS, MDS/AML who requires and allogeneic stem cell transplant.
- For AML and MDS/AML, bone marrow myeloblasts <5% at pre-transplant bone marrow sample with no circulating blasts. For MDS patients, pre-transplant bone marrow myeloblasts < 10%
- Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD/MUD/Haplo/UCB) is permitted.
- Participants must be 18 years of age or older.
- Total bilirubin < 2.0 mg/dL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin < 2 × ULN).
Key exclusion criteria (15 listed)
- Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician
- Currently pregnant or breast-feeding. Females of childbearing (FOCBP) potential must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months (therefore not naturally post-menopausal for > 12 months)
- Uncontrolled comorbid illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to:
- FOCBP and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, they should inform the treating physician immediately
- Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of decitabine/venetoclax.
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 |
|---|---|---|
| VenetoclaxVenetoclax is a BCL2 inhibitor. It is administered at low doses and used in combination with other hypomethylating agents such as decitabine to manage participants with acute myeloid lymphoma who have undergone stem cell transplant. Participants will initiate therapy with decitabine that will be followed by venetoclax 400 mg oral 6-8 hours later. Participants will continue this dose each week. The venetoclax dose will be reduced to 100 mg once per week if the participant is being treated with posaconazole or voriconazole (strong CYP3A4 inhibitors) (considered dose equivalent to venetoclax 400 mg 1X/week). The venetoclax dose will be reduced 200 mg once per week if the participant is being treated with fluconazole or isavuconazole (moderate CYP3A4 inhibitors) (considered dose equivalent to venetoclax 400 mg 1X/week). This clinical trial is administering venetoclax well below the current FDA approved dosing. | Drug | Low dose maintenance chemotherapy |
| DecitabineDecitabine is a hypomethylating agent. It is administered at low doses and used in combination with venetoclax to manage participants with acute myeloid lymphoma who have undergone stem cell transplant. Participants initiate therapy with 5 mg/m2 decitabine subcutaneous every week followed by venetoclax. | Drug | Low dose maintenance chemotherapy |
Primary outcome
Safety as measured by dose limiting toxicities
Time frame: 1 year after treatment
The primary objective of this study will be to assess the safety of low dose decitabine/venetoclax in the post transplant setting. Safety will be defined in accordance with FDA guidance on development for new therapeutics in AML with the particular criteria to be considered as DLTs. The stopping criteria are described for the incidence of dose limiting toxicities that are at least possibly related to the study treatment. Using Bayesian toxicity monitoring with maximum DLT probability as 0.15, prior distribution (0.5, 0.5), maximum participants 20, minimum number of participants before stopping 9, cohort size 5, and posterior probability 0.8, the study will be paused for review if (2, 3, 4, 5) or more participants experiencing such Grade 4 events in (69, 11, 16, 20) participants, respectively.
Feasibility as measured by the rate of participants receiving planned treatment
Time frame: 1 year after treatment
The primary objective of this study will be to assess the feasibility of low dose decitabine/venetoclax in the post transplant setting. Feasibility will be defined as ≥ 80% of participants receiving ≥80% of planned decitabine/venetoclax doses, excluding participants removed from the study in the event of relapse.
1 secondary outcome
Rate of relapse free survival
Time frame: 1 year after treatment
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual Participant data that underlie or influence the results observed from the study
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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.
Benjamin Tomlinson, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
James Ignatz-Hoover, MD, PhD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Claudio Brunstein, MD, PhD principal investigator
Cleveland Clinic Foundation, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Venetoclax and Decitabine in people with Myeloid Malignancy and Acute Myeloid Leukemia, run by Benjamin Tomlinson 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 15 inclusion and 15 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 8 Oct 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Benjamin Tomlinson, MD ((216) 844-0139, Benjamin.tomlinson@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as measured by dose limiting toxicities (time frame: 1 year after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.