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Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia (MIDOVEN)

21 июля 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

41

Фаза

  • Фаза 2
  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Учебное резервное копирование контактов

Места учебы

  • Франция
      • Bayonne, Франция, 64100
        • CH de la Côte Basque
        • Контакт:
          • Anne BANOS, Dr
          • Номер телефона: +33 5 59 44 38 32
          • Электронная почта: abanos@ch-cotebasque.fr
      • Pessac, Франция, 33600
        • CHU de Bordeaux - Hôpital Haut-Lévêque
        • Контакт:
      • Toulouse, Франция, 31059
        • CHU de Toulouse
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Main inclusion criteria:

  1. Age ≥18 years and ≤70 years
  2. Newly diagnosed AML according to World Health Organization (WHO) 2022 classification

  3. 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%.

  4. Patient must be eligible for intensive chemotherapy.

Main exclusion criteria:

  1. Prior treatment for AML or myelodysplastic (MDS) phase.
  2. Prior exposure to VEN or other BCL2 inhibitors
  3. AML secondary to prior hematological disorders, including myelodysplastic syndrome, myeloproliferative disorders and/or therapy-related AML.
  4. Acute promyelocytic leukemia, CBF-AML, Phi+ AML
  5. Significant active cardiac disease within 6 months prior to the start of study treatment or QTc interval using Fridericia's formula (QTcF) ≥ 450 msec.
  6. Cardiac ejection fraction <45%

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Standard treatment of FLT3 mutated AML
Лекарство: Venetoclax in association with 3+7 and midostaurin
(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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Phase 1: Maximum tolerated schedule (MTS) of VEN in combination with 3+7+MIDO to define the recommended phase 2 schedule (RP2S).
Временное ограничение: 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)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Phase 1:Number of participants with Dose Limiting Toxicities (DLTs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to treatment discontinuation
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University Hospital, Bordeaux

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 сентября 2026 г.

Первичное завершение (Оцененный)

1 сентября 2027 г.

Завершение исследования (Оцененный)

1 декабря 2031 г.

Даты регистрации исследования

Первый отправленный

29 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

21 июля 2026 г.

Первый опубликованный (Действительный)

24 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

24 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 июля 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CHUBX 2024/37

Планирование данных отдельных участников (IPD)

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НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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