Leukemia Acute MyeloidPhase 2RAVENNCT07605949
Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
A Phase 2 study testing Azacitidine, Venetoclax and Revumenib in people with Leukemia Acute Myeloid, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia Acute Myeloid
- What is being tested?
- Azacitidine, Venetoclax and Revumenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jul 2028
- Phase
- Phase 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age 18-65 years at the time of consent.
- Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics/karyotype or FISH
Who cannot join
- Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study)
- Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Lauren Higgins, 919-984-0000, Lauren_Higgins@med.unc.edu
Joshua Zeidner
About this study
This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML.
People with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects.
Read more
The study has two parts:
- Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission.
- Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs.
Patients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.
- Conditions
- Leukemia Acute Myeloid
- Being tested
- Azacitidine, Venetoclax, Revumenib
- Keywords
- revumenib, azacitidine, venetoclax, allogeneic 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.
AzacitidineDrug
Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.
VenetoclaxDrug
Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.
RevumenibDrug
Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) | Experimental | Patients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment. Receives: Drug: Azacitidine; Drug: Venetoclax; Drug: Revumenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
Complete remission (CR) rate will be determined as defined in the protocol Response Criteria. Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC > 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)
Measured: Up to 3 months
Secondary outcomes (7)
Composite Complete remission
Composite Complete remission (CCr) rate defined as complete remission (CR) + complete remission with incomplete recovery (CRi) + complete remission with partial hematologic recovery (CCr)= CR + CRi + CRh.
CR: Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC > 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL) CRi = All CR criteria except for residual neutropenia <1.0 × 109/L (1,000/μL) or thrombocytopenia < 100× 109/L (100 000/μL CRh: ANC ≥ 0.5 × 109/L (500/μL) and platelet count ≥50 × 109/L (50 000/μL), otherwise all other CR criteria met.
Measured: Up to 3 months
Duration of complete remission (DOCR)
Duration of complete remission (DOCR) will be defined as the time from the first complete remission to hematological relapse or death from any cause. CR: Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC > 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)
Measured: Up to 2 years
Event-free survival
Event-free survival will be determined as time until treatment failure (lack of CRc), relapse or death.
Measured: Up to 2 years
The number of treatment-emergent adverse events
The number of treatment-emergent special interest (AESIs) and serious adverse events (SAEs), and clinically significant test results will be submitted.
Measured: Up to 2 years
Relapse-free survival
Relapse-free survival will be determined as time to relapse or death after achieving CR.
Measured: Up to 2 years
Overall survival
Overall survival will be determined as time until date of death from any cause.
Measured: Up to 2 years
MRD-Negative (MRD<0.02%) complete remission
MRD-Negative (MRD<0.02%) complete remission rate will be assessed from bone marrow samples using Hematologics Flow MRD assay after 2 cycles of RAVEN treatment
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startDec 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia Acute MyeloidStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study uses a structured, stepwise design. All participants begin with induction therapy. Patients who do not respond discontinue treatment, while those who achieve remission proceed to the continuation phase. During continuation therapy, patients may either remain on treatment until relapse/progression or proceed to allogeneic stem cell transplant.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Zeidner, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605949
- Sponsor's protocol ID
- LCCC2508
- Acronym
- RAVEN
- Status last verified
- Nov 2026
- First submitted
- 18 May 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
- ClinicalTrials.gov ID
- NCT07605949
- Acronym / sponsor ID
- RAVEN / LCCC2508
- Conditions
- Leukemia Acute Myeloid
- Keywords
- revumenib, azacitidine, venetoclax, allogeneic stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 26 May 2026 (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 study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML.
People with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects.
The study has two parts:
- Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission.
- Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs.
Patients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study uses a structured, stepwise design. All participants begin with induction therapy. Patients who do not respond discontinue treatment, while those who achieve remission proceed to the continuation phase. During continuation therapy, patients may either remain on treatment until relapse/progression or proceed to allogeneic stem cell transplant.
| Arm | Type | Receives |
|---|---|---|
| KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) | Experimental | Drug: Azacitidine, Drug: Venetoclax, Drug: RevumenibPatients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age 18-65 years at the time of consent.
- Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics/karyotype or FISH
Key exclusion criteria (3 listed)
- Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study)
- Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
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 |
|---|---|---|
| AzacitidineSubcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles. | Drug | KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) |
| VenetoclaxPer oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles. | Drug | KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) |
| RevumenibPer oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles. | Drug | KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) |
Primary outcome
Complete remission rate
Time frame: Up to 3 months
Complete remission (CR) rate will be determined as defined in the protocol Response Criteria. Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC > 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)
7 secondary outcomes
Composite Complete remission
Time frame: Up to 3 months
Duration of complete remission (DOCR)
Time frame: Up to 2 years
Event-free survival
Time frame: Up to 2 years
The number of treatment-emergent adverse events
Time frame: Up to 2 years
Relapse-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
MRD-Negative (MRD<0.02%) complete remission
Time frame: Up to 3 months
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 5 Nov 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
Related trials for Leukemia Acute Myeloid
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.
Joshua Zeidner, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine, Venetoclax and Revumenib in people with Leukemia Acute Myeloid, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 Lauren Higgins (919-984-0000, Lauren_Higgins@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: Up to 3 months). 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 5 Nov 2026.