Skip to content

MRD registry and multicenter, randomized controlled pragmatic trial of standard intensity versus reduced intensity consolidation treatment in MRD-negative patients with AML or CLL (RESOLVE trial).

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512503-39-00
Acronym
RESOLVE trial
Enrollment
52
Registered
2025-07-07
Start date
2025-12-19
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arm A (AML): Newly diagnosed de novo Acute myeloid leukemia (AML) or MDS/AML (MDS = Myelodysplastic syndrome) patients according to ICC 2022 or newly diagnosed AML or MDS-IB2 patients according to WHO 2022 classifications Arm B (CLL): Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

Brief summary

MRD registry, Arm A (AML): Frequency of MRD negative CR/CRi/CRh in AML patients after 1-2 cycles with standard induction therapy., MRD registry, Arm B (CLL): Frequency of uMRD at first on-treatment MRD assessment (VEN + anti-CD20 MoAb: C7D1 after treatment start; VEN + BTKi ibrutinib: C9D1 after treatment start), RESOLVE trial, Arm A (AML): Overall survival (OS), RESOLVE trial, Arm B (CLL): Average overall adverse event burden score based on physician assessment during the period from randomization to AE score 03 assessment (C14D1 for venetoclax + moAB treated patients; C16D1 for venetoclax + BTKi ibrutinib treated patients).

Detailed description

MRD registry, Arm A (AML): Rate of CR defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Rate of CR with incomplete hematologic recovery (CRi) rate defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Rate of CR with partial hematologic recovery (CRh) rate defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Rate of morphologic leukemia-free state (MLFS) defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Frequency of reasons for non-participation in the RESOLVE trial., MRD registry, Arm B (CLL): Rate of uMRD in peripheral blood at the time of MRD1 and MRD2 assessments., MRD registry, Arm B (CLL): Frequency of reasons for non-participation in the RESOLVE trial., RESOLVE trial, Arm A (AML): GvHD-free-relapse-free survival (GRFS) in groups 1 and 2 measured from the date of randomization until the date of hematologic relapse or death from any cause or grade III–IV acute GvHD or chronic GVHD that requires systemic treatment, RESOLVE trial, Arm A (AML): Cumulative incidence of relapse (CIR) in groups 1 and 2 measured from the date of achievement of a remission until the date of hematologic relapse; patients not known to have relapsed are censored on the date they were last assessed for response; death without relapse will be considered as competing event., RESOLVE trial, Arm A (AML): Cumulative incidence of non-relapse mortality (CID) in groups 1 and 2 defined as death in CR/CRi/CRh/MLFS and measured from randomization to death with relapse as a competing event. Patients who are not known to have relapsed or died will be censored at the date of last response assessment., RESOLVE trial, Arm B (CLL): Average overall adverse event burden score based on physician assessment excluding laboratory AEs from randomization to AE score 3 assessment (C14D1 for venetoclax + moAb treated patients; C16D1 for venetoclax + BTKi ibrutinib treated patients)., RESOLVE trial, Arm B (CLL): Duration of response (DOR) measured from randomization to the date that disease progression is objectively documented or death, whichever occurs first., RESOLVE trial, Arm B (CLL): 3-year progression-free survival (PFS) measured from randomization until the date of disease progression or death from any cause.

Interventions

DRUGETOPOSIDE
DRUGCLADRIBINE
DRUGCYTARABINE
DRUGCYTARABINE AND DAUNORUBICIN
DRUGCYCLOPHOSPHAMIDE
DRUGMITOXANTRONE
DRUGDAUNORUBICIN
DRUGMIDOSTAURIN
DRUGIBRUTINIB
DRUGOBINUTUZUMAB
DRUGTREOSULFAN
DRUGFLUDARABINE
DRUGGEMTUZUMAB OZOGAMICIN
DRUGIDARUBICIN
DRUGQUIZARTINIB
DRUGTHIOTEPA
DRUGBUSULFAN
DRUGVENETOCLAX

Sponsors

Medizinische Hochschule Hannover
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
MRD registry, Arm A (AML): Frequency of MRD negative CR/CRi/CRh in AML patients after 1-2 cycles with standard induction therapy., MRD registry, Arm B (CLL): Frequency of uMRD at first on-treatment MRD assessment (VEN + anti-CD20 MoAb: C7D1 after treatment start; VEN + BTKi ibrutinib: C9D1 after treatment start), RESOLVE trial, Arm A (AML): Overall survival (OS), RESOLVE trial, Arm B (CLL): Average overall adverse event burden score based on physician assessment during the period from randomization to AE score 03 assessment (C14D1 for venetoclax + moAB treated patients; C16D1 for venetoclax + BTKi ibrutinib treated patients).

Secondary

MeasureTime frame
MRD registry, Arm A (AML): Rate of CR defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Rate of CR with incomplete hematologic recovery (CRi) rate defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Rate of CR with partial hematologic recovery (CRh) rate defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Rate of morphologic leukemia-free state (MLFS) defined by ELN 2022 after 1-2 cycles of chemotherapy., MRD registry, Arm A (AML): Frequency of reasons for non-participation in the RESOLVE trial., MRD registry, Arm B (CLL): Rate of uMRD in peripheral blood at the time of MRD1 and MRD2 assessments., MRD registry, Arm B (CLL): Frequency of reasons for non-participation in the RESOLVE trial., RESOLVE trial, Arm A (AML): GvHD-free-relapse-free survival (GRFS) in groups 1 and 2 measured from the date of randomization until the date of hematologic relapse or death from any cause or grade III–IV acute G

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026