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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Lauren Higgins
- 電話番号：919-984-0000
- メール：Lauren_Higgins@med.unc.edu
研究場所
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
コンタクト：
- Lauren Higgins
- 電話番号：919-984-0000
- メール：Lauren_Higgins@med.unc.edu
-
主任研究者：
- Joshua Zeidner
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete remission rate
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Composite Complete remission
時間枠：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)
時間枠：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)
|
Up to 2 years
|
|
Event-free survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Joshua Zeidner, MD、UNC Lineberger Comprehensive Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LCCC2508
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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