Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia (MIDOVEN)
2026년 7월 21일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
41
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Pierre-Yves DUMAS, PU-PH
- 전화번호: +33 5 57 65 65 11
- 이메일: pierre-yves.dumas@chubordeaux.fr
연구 연락처 백업
- 이름: Sarah BERTOLI
- 전화번호: +33 5 31 15 62 69
- 이메일: bertoli.sarah@iuct-oncopole.fr
연구 장소
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Bayonne, 프랑스, 64100
- CH de la Côte Basque
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연락하다:
- Anne BANOS, Dr
- 전화번호: +33 5 59 44 38 32
- 이메일: abanos@ch-cotebasque.fr
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Pessac, 프랑스, 33600
- CHU de Bordeaux - Hôpital Haut-Lévêque
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연락하다:
- Pierre-Yves DUMAS, PU-PH
- 전화번호: +33 5 57 65 65 11
- 이메일: pierre-yves.dumas@chu-bordeaux.fr
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Toulouse, 프랑스, 31059
- CHU de Toulouse
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연락하다:
- Sarah BERTOLI, Dr
- 전화번호: +33 5 31 15 62 69
- 이메일: bertoli.sarah@iuct-oncopole.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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%
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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 |
|---|---|
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실험적: Standard treatment of FLT3 mutated AML
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(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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase 1: Maximum tolerated schedule (MTS) of VEN in combination with 3+7+MIDO to define the recommended phase 2 schedule (RP2S).
기간: From day 1 of induction chemotherapy up to 8 weeks
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From day 1 of induction chemotherapy up to 8 weeks
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Phase 2: Proportion of participants with complete remission (CR)/CR with incomplete hematologic recovery (CRi) without measurable residual disease (MRD)
기간: From day 1 of induction chemotherapy up to 8 weeks
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Measured by multiparameter flow cytometry (MFC) according to European Leukemia Net (ELN) 2022
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From day 1 of induction chemotherapy up to 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase 1:Number of participants with Dose Limiting Toxicities (DLTs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to treatment discontinuation
기간: 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
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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
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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
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Phase 1-2: Area under the concentration-time curve over a 12-hour dosing interval (- AUC 0-12h)
기간: 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
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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
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Phase 1-2: Peak concentration (Cmax)
기간: 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
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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
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|
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Phase 1-2: Time to reach peak concentration (Tmax)
기간: 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
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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
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|
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Phase 1-2: Through concentration (Cmin)
기간: 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
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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
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Phase 1-2: Steady-state accumulation ratios of AUC 0-12h
기간: 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
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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
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|
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Phase 1-2: Steady-state accumulation ratios of Cmax
기간: 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
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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
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Phase 1-2: Area under the plasma concentration-time profile from time zero to time tau (AUCtau)
기간: 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
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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
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Phase 1-2: Area under the concentration-time curve extrapolated to infinity (AUCinf)
기간: 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
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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
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Phase 1: Half time (T1/2)
기간: 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
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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
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Phase 1-2: Oral clearance (CL/F)
기간: 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
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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
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Phase 1-2: Volume or volume/kg (Vz/F)
기간: 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
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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
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Phase 2: Number of participants experiencing at least one treatment-related adverse event, or at least one serious treatment-related adverse event
기간: 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
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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
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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
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Phase 2: Number of participants experiencing at least one adverse event that led to discontinuation of treatment
기간: 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
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Number of participants experiencing at least one adverse event that led to discontinuation of treatment, defined according to the NCI CTCAE v5
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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
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Phase 1-2: Proportion of participants with complete remission (CR)/CR with incomplete hematologic recovery (CRi) without measurable residual disease (MRD)
기간: 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
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Measured by MFC according to ELN2022 and with a sensitivity at 10-4 or limit of detection (LOD)
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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
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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
기간: From day 1 of induction chemotherapy up to 8 weeks
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From day 1 of induction chemotherapy up to 8 weeks
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Proportion of participants with CR/CRi/CRh without MRD
기간: 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
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Measured by MFC according to ELN2022 and with a sensitivity at 10-4 or LOD
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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
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Proportion of participants with CR/CRi without MRD
기간: 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
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Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
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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
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Proportion of participants with CR/CRi/CRh without MRD
기간: 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
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Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
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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
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Proportion of participants with CR/CRi with MRD low-level (MRDLL)
기간: 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
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Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
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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
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Proportion of participants with CR/CRi/CRh with MRDLL
기간: 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
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Measured by RT-qPCR on NPM1 in co-mutated FLT3 and NPM1 subgroup
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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
|
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Proportion of participants with CR/CRi without MRD
기간: 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
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Measured by NGS on FLT3 in FLT3-ITD subgroup
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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
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Proportion of participants with CR/CRi/CRh without MRD
기간: 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
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Measured by NGS on FLT3 in FLT3-ITD subgroup
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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
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Overall survival (OS)
기간: From day 1 of inclusion until the date of end of study or to the date of death from any cause
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Time from start of treatment to death due to any cause
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From day 1 of inclusion until the date of end of study or to the date of death from any cause
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Event-free survival (EFS) and EFS including MRD relapse (RT-qPCR on NPM1 and/or NGS FLT3-ITD and/or MFC) as event (EFSMRD)
기간: 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
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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
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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
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Relapse-free survival (RFS), and RFS including MRD relapse (RT-qPCR on NPM1 and/or NGS FLT3-ITD and/or MFC) as event (RFSMRD)
기간: 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
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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
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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
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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)
기간: From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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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
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From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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Proportion of participants with HSCT performed in CR/CRi in eligible patients
기간: From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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Proportion of participants with HSCT performed CR/CRi/CRh in eligible patients
기간: From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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Proportion of participants with HSCT performed in CR/CRi/CRh/MLFS in eligible patients
기간: From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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From date of CR until the date of first documented progression, including molecular progression assessed up to 24 months
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To describe PK of VEN
기간: 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
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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
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To describe MIDO and MIDO metabolites CPG52421 and CPG62221 at the RP2S
기간: 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
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 9월 1일
연구 완료 (추정된)
2031년 12월 1일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 7월 21일
처음 게시됨 (실제)
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 21일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHUBX 2024/37
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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미국 FDA 규제 기기 제품 연구
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .