Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia (MIDOVEN)
2026年7月21日 更新者：University Hospital, Bordeaux
Phase 1/2 Evaluating the Addition of Venetoclax to Standard 3+7 and Midostaurin Induction Treatment in Patients With FLT3-mutated Acute Myeloid Leukemia Eligible to Intensive Chemotherapy - MIDOVEN
Acute myeloid leukemia (AML) with FLT3 mutation accounts for 30% of patients and is associated with a poor prognosis.
Because of the FLT3 mutation, a tyrosine kinase inhibitor, midostaurin (MIDO), is added to the standard treatment with daunorubicin and cytarabine, from D8 to D21 of induction and of each consolidation cycle, followed by one year of maintenance.
Venetoclax (VEN), a BCL2 inhibitor, has revolutionized the management of AML patients ineligible for intensive chemotherapy, in combination with azacitidine or cytarabine.
The investigators hypothesize that a four-drug induction regimen (daunorubicin+cytarabine+MIDO+VEN) will increase complete remission (CR) rate without measurable residual disease (MRD) and improve event free survival (EFS), relapse free survival (RFS) and overall survival (OS) of this subgroup of patients with unmet medical need.
調査の概要
詳細な説明
Screening of 226 clinical trials on ClinTrial.gov
showed 26 studies evaluating intensive chemotherapy (daunorubicin+cytarabine) and VEN but none in combination with MIDO even though 30% of patients eligible for intensive chemotherapy do receive such a regimen.
Intensive chemotherapy and MIDO showed a significant median overall survival improvement but a moderate increase of patients still alive at 3 years, around an additional 10% 1.
Moreover, MIDO does not allow an increase in proportion of patients in first complete remission (CR1) or CR with incomplete hematologic recovery (CRi1) after the 1st induction course.
Another study with a second-generation tyrosine kinase inhibitor, quizartinib (QuANTUM-First) showed that among patients with CR1/CRi1, 42% had a measurable residual disease (MRD) <10-4 in quizartinib arm versus 38% in placebo arm, despite, here again, a significant median overall survival improvement 2. These data show that tyrosine kinase inhibitors do not increase the rate of complete remission (CR) without MRD, explaining probably the moderate improvement of definitive cure rate.
The investigators hypothesize that adding VEN to this standard treatment will increase complete remission rate without MRD and improve OS of patients with FLT3-mutated AML.
Two clinical trials evaluated VEN in AML patients eligible to intensive chemotherapy and showed high levels of complete remission without MRD and a manageable toxicity profile, related to VEN start date and duration of exposure 3,4.
In the current study, the investigators propose the following schedule to find the best treatment sequence while preventing the risk of myelosuppression, based on available data from the two clinical trials previously presented: In schedule A, VEN will be used from D8 to D14 to harness the synergy between FLT3 and BCL2 inhibition; in schedule B, VEN will be used from D4 to D10 to harness the synergy between chemotherapy and BCL2 inhibition then between FLT3 and BCL2 inhibition.
If previous schedules A and B are safe, the investigators propose to prolong VEN exposure to 10 days allowing longer association between MIDO and VEN with a schedule C with VEN from D8 to D17 and finally a schedule D with VEN from D4 to D13.
Follow-up will include up to 3 consolidation courses with intermediate dose cytarabine and VEN according to previous French phase 2 clinical trial COVENIDAC 5 and MIDO in this label from D8 to D21.
Finally, patients will receive 12 cycles maintenance by MIDO with VEN D1-D14 in 28-day cycles.
Patients will undergo allogeneic stem cell transplantation (HSCT) according to standard indications and procedures.
研究の種類
介入
入学 (推定)
41
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Pierre-Yves DUMAS, PU-PH
- 電話番号：+33 5 57 65 65 11
- メール：pierre-yves.dumas@chubordeaux.fr
研究連絡先のバックアップ
- 名前：Sarah BERTOLI
- 電話番号：+33 5 31 15 62 69
- メール：bertoli.sarah@iuct-oncopole.fr
研究場所
-
-
-
Bayonne、フランス、64100
- CH de la Côte Basque
-
コンタクト：
- Anne BANOS, Dr
- 電話番号：+33 5 59 44 38 32
- メール：abanos@ch-cotebasque.fr
-
Pessac、フランス、33600
- CHU de Bordeaux - Hopital Haut-Leveque
-
コンタクト：
- Pierre-Yves DUMAS, PU-PH
- 電話番号：+33 5 57 65 65 11
- メール：pierre-yves.dumas@chu-bordeaux.fr
-
Toulouse、フランス、31059
- CHU de Toulouse
-
コンタクト：
- Sarah BERTOLI, Dr
- 電話番号：+33 5 31 15 62 69
- メール：bertoli.sarah@iuct-oncopole.fr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Main inclusion criteria:
- Age ≥18 years and ≤70 years
- Newly diagnosed AML according to World Health Organization (WHO) 2022 classification
Documented FLT3 gene mutation (-TKD D835 or I836 or -ITD or both) FLT3-ITD is assessed by DNA fragment analysis. Positivity is defined as an ITD/wt ratio of ≥ 0.05 (5%).
FLT3-TKD D835 or I836 is assessed by NGS. Positivity is defined as a VAF > 5%.
- Patient must be eligible for intensive chemotherapy.
Main exclusion criteria:
- Prior treatment for AML or myelodysplastic (MDS) phase.
- Prior exposure to VEN or other BCL2 inhibitors
- AML secondary to prior hematological disorders, including myelodysplastic syndrome, myeloproliferative disorders and/or therapy-related AML.
- Acute promyelocytic leukemia, CBF-AML, Phi+ AML
- Significant active cardiac disease within 6 months prior to the start of study treatment or QTc interval using Fridericia's formula (QTcF) ≥ 450 msec.
- Cardiac ejection fraction <45%
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：Standard treatment of FLT3 mutated AML
|
(1) induction with daunorubicin 60 mg/m²/day for 3 days, cytarabine 200 mg/m²/day for 7 days and MIDO 50 mg x 2/day from D8 to D21, (2) consolidation with 3 courses of intermediate dose cytarabine 1-1.5 gr/m² x 2/day at D1, D2 and D3 and MIDO 50 mg x 2/day from D8 to D21 in 35-day cycles, and (3) a maintenance with MIDO 50 mg x 2/day from D1 to D28 in 28-day cycles for 12 cycles.
VEN is a highly potent BCL-2 inhibitor, synergistic with cytarabine, anthracyclines, and tyrosine kinase inhibitors.
In the current study we aim at harnessing this synergistic effect with standard chemotherapy (cytarabine, anthracyclines) and tyrosine kinase inhibitor (MIDO) during induction, consolidation and maintenance.
Our strategy aims at determining the best schedule of combination during induction chemotherapy whereas we do not foresee specific safety issues during consolidation and maintenance strategy
|
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 |
|---|---|---|
|
Phase 1: Maximum tolerated schedule (MTS) of VEN in combination with 3+7+MIDO to define the recommended phase 2 schedule (RP2S).
時間枠：From day 1 of induction chemotherapy up to 8 weeks
|
From day 1 of induction chemotherapy up to 8 weeks
|
|
|
Phase 2: Proportion of participants with complete remission (CR)/CR with incomplete hematologic recovery (CRi) without measurable residual disease (MRD)
時間枠：From day 1 of induction chemotherapy up to 8 weeks
|
Measured by multiparameter flow cytometry (MFC) according to European Leukemia Net (ELN) 2022
|
From day 1 of induction chemotherapy up to 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1:Number of participants with Dose Limiting Toxicities (DLTs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to treatment discontinuation
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
Number of participants with Dose Limiting Toxicities (DLTs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to treatment discontinuation, defined according to the NCI CTCAE v5
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
Phase 1-2: Area under the concentration-time curve over a 12-hour dosing interval (- AUC 0-12h)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Peak concentration (Cmax)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Time to reach peak concentration (Tmax)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Through concentration (Cmin)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Steady-state accumulation ratios of AUC 0-12h
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Steady-state accumulation ratios of Cmax
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Area under the plasma concentration-time profile from time zero to time tau (AUCtau)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Area under the concentration-time curve extrapolated to infinity (AUCinf)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1: Half time (T1/2)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Oral clearance (CL/F)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 1-2: Volume or volume/kg (Vz/F)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
|
Phase 2: Number of participants experiencing at least one treatment-related adverse event, or at least one serious treatment-related adverse event
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
Number of participants experiencing at least one treatment-related adverse event, or at least one serious treatment-related adverse event, , defined according to the NCI CTCAE v5
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
Phase 2: Number of participants experiencing at least one adverse event that led to discontinuation of treatment
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
Number of participants experiencing at least one adverse event that led to discontinuation of treatment, defined according to the NCI CTCAE v5
|
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
Phase 1-2: Proportion of participants with complete remission (CR)/CR with incomplete hematologic recovery (CRi) without measurable residual disease (MRD)
時間枠：Day 1 of Consolidation 2, day 1 of consolidation 3 , day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, day 1 of maintenance cycle 7, day 1 of maintenance cycle 10 and day 28 of maintenance cycle 12
|
Measured by MFC according to ELN2022 and with a sensitivity at 10-4 or limit of detection (LOD)
|
Day 1 of Consolidation 2, day 1 of consolidation 3 , day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, day 1 of maintenance cycle 7, day 1 of maintenance cycle 10 and day 28 of maintenance cycle 12
|
|
Proportion of participants with complete remission (CR), CR with incomplete hematologic recovery (Cri), CR with partial hematological recovery (CRh), morphologic leukemia free state (MLFS), partial response (PR), no response, non-evaluable for response
時間枠：From day 1 of induction chemotherapy up to 8 weeks
|
From day 1 of induction chemotherapy up to 8 weeks
|
|
|
Proportion of participants with CR/CRi/CRh without MRD
時間枠：Day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, day 1 of maintenance cycle 7, day 1 of maintenance cycle 10 and day 28 of maintenance cycle 12
|
Measured by MFC according to ELN2022 and with a sensitivity at 10-4 or LOD
|
Day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, day 1 of maintenance cycle 7, day 1 of maintenance cycle 10 and day 28 of maintenance cycle 12
|
|
Proportion of participants with CR/CRi without MRD
時間枠：From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
|
From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
|
Proportion of participants with CR/CRi/CRh without MRD
時間枠：From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
|
From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
|
Proportion of participants with CR/CRi with MRD low-level (MRDLL)
時間枠：From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
|
From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
|
Proportion of participants with CR/CRi/CRh with MRDLL
時間枠：From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
|
From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
|
Proportion of participants with CR/CRi without MRD
時間枠：From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
Measured by NGS on FLT3 in FLT3-ITD subgroup
|
From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
|
Proportion of participants with CR/CRi/CRh without MRD
時間枠：From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
Measured by NGS on FLT3 in FLT3-ITD subgroup
|
From day 1 of induction chemotherapy up to 8 weeks, day 1 of Consolidation 2, day 1 of consolidation 3, day 28 of consolidation 3, day 1 of maintenance cycle 1, day 1 of maintenance cycle 4, cycle 7, cycle 10 and day 28 of maintenance cycle 12
|
|
Overall survival (OS)
時間枠：From day 1 of inclusion until the date of end of study or to the date of death from any cause
|
Time from start of treatment to death due to any cause
|
From day 1 of inclusion until the date of end of study or to the date of death from any cause
|
|
Event-free survival (EFS) and EFS including MRD relapse (RT-qPCR on NPM1 and/or NGS FLT3-ITD and/or MFC) as event (EFSMRD)
時間枠：From date of day 1 of induction chemotherapy until the date of first documented progression, including molecular progression or date of death from any cause, whichever came first, assessed up to 24 months
|
From day 1 of inclusion to the date of treatment failure, hematologic relapse from CR/CRh/CRi or death from any cause, whichever occurs first (ELN 2022 criteria).
MRD relapse is also considered as an event for EFSMRD
|
From date of day 1 of induction chemotherapy until the date of first documented progression, including molecular progression or date of death from any cause, whichever came first, assessed up to 24 months
|
|
Relapse-free survival (RFS), and RFS including MRD relapse (RT-qPCR on NPM1 and/or NGS FLT3-ITD and/or MFC) as event (RFSMRD)
時間枠：From date of CR until the date of first documented progression, including molecular progression or date of death from any cause, whichever came first, assessed up to 24 months
|
Defined only for patients achieving CR, CRh, or CRi; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause (ELN 2022 criteria).
MRD relapse is also considered as an event for RFSMRD
|
From date of CR until the date of first documented progression, including molecular progression or date of death from any cause, whichever came first, assessed up to 24 months
|
|
Cumulative incidence of relapse (CIR), and CIR including MRD relapse (RT-qPCR on NPM1 and/or NGS FLT3-ITD and/or MFC) as event (CIRMRD)
時間枠：From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
Defined for all patients achieving CR, CRh, CRi; measured from the date of achievement of a remission until the date of hematologic relapse (ELN 2022 criteria).
MRD relapse is also considered as an event for CIRMRD
|
From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
|
Proportion of participants with HSCT performed in CR/CRi in eligible patients
時間枠：From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
|
|
Proportion of participants with HSCT performed CR/CRi/CRh in eligible patients
時間枠：From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
|
|
Proportion of participants with HSCT performed in CR/CRi/CRh/MLFS in eligible patients
時間枠：From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
|
|
|
To describe PK of VEN
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
During induction, plasma samples will be collected at the following time points for VEN treatment: Pre-dose, 1, 2, 4, and a last one between 6- and 8-hours post-dose at D14 for schedule A, at D10 for schedule B, at D17 forschedule C and D13 for schedule D At each consolidation, only pre-dose at D14 of each consolidation cycle During maintenance, only pre-dose at D14 of 2nd, 3rd and 4th maintenance cycles |
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
|
To describe MIDO and MIDO metabolites CPG52421 and CPG62221 at the RP2S
時間枠：From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
During induction, plasma samples will be collected at the following time points for MIDO treatment: Pre-dose, 1, 2, 4, and a last one between 6- and 8-hours post-dose at D21 of induction At each consolidation, only pre-dose at D14 or D15 or D16 of each consolidation cycle, During maintenance, only pre-dose at D1 of 2nd, 3rd and 4th maintenance cycles |
From day 1 of induction chemotherapy up to 8 weeks, then from day 1 of each of 3 consolidation chemotherapy up to 8 weeks and from day 1 of first maintenance cycle up to 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2031年12月1日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年7月21日
最初の投稿 (実際)
2026年7月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。