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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) | Experimental | Patients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Higgins | Contact | 919-984-0000 | Lauren_Higgins@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joshua Zeidner, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| C579720 | venetoclax |
| C000728983 | revumenib |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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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.
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| Venetoclax | Drug | Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles. |
|
| Revumenib | Drug | Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles. |
|
| 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) | Up to 2 years |
| Event-free survival | Event-free survival will be determined as time until treatment failure (lack of CRc), relapse or death. | 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. | Up to 2 years |
| Relapse-free survival | Relapse-free survival will be determined as time to relapse or death after achieving CR. | Up to 2 years |
| Overall survival | Overall survival will be determined as time until date of death from any cause. | 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 | Up to 3 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |