Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML (RAVEN)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Lauren Higgins
- 전화번호: 919-984-0000
- 이메일: Lauren_Higgins@med.unc.edu
연구 장소
-
-
North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
연락하다:
- Lauren Higgins
- 전화번호: 919-984-0000
- 이메일: Lauren_Higgins@med.unc.edu
-
수석 연구원:
- Joshua Zeidner
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)
Patients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment.
|
Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.
Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.
Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Complete remission rate
기간: 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)
|
Up to 3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Composite Complete remission
기간: Up to 3 months
|
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. |
Up to 3 months
|
|
Duration of complete remission (DOCR)
기간: Up to 2 years
|
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)
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Up to 2 years
|
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Event-free survival
기간: Up to 2 years
|
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
기간: Up to 2 years
|
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
기간: Up to 2 years
|
Relapse-free survival will be determined as time to relapse or death after achieving CR.
|
Up to 2 years
|
|
Overall survival
기간: Up to 2 years
|
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
기간: Up to 3 months
|
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Joshua Zeidner, MD, UNC Lineberger Comprehensive Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- LCCC2508
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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