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Registry and clinical trial comparing standard intensity and reduced intensity treatment in patients with AML or CLL who do not have residual disease.
EU CTIS ID: 2024-512503-39-00
What this study is testing
● MRD registry, Arm A (AML): To determine the frequency of MRD negative complete remission (CR), CR with incomplete hematologic recovery (CRi) and CR with partial hematologic recovery (CRh) in the registered cohort of AML patients with ELN intermediate risk who have been treated with standard induction chemotherapy for 1-2 cycles. ● MRD registry, Arm B (CLL): To determine the frequency of undetectable MRD (uMRD) in treatment-naive CLL patients who have been treated with fixed duration treatments for 7 or 9 cycles, depending on the treatment regimen. ● RESOLVE trial, Arm A (AML): To evaluate non-inferiority of non-alloHCT consolidation (group 2) compared to alloHCT consolidation (group 1) with regard to overall survival (OS) in intermediate-risk AML patients who tested MRD-negative after 1-2 cycles of induction chemotherapy. ● RESOLVE trial, Arm B (CLL): To demonstrate a lower average overall adverse event burden score based on physician assessment during the first 6 months after randomization in patients with CLL achieving uMRD who stopped treatment at the time of randomization (treatment group 4) compared to those completing fixed-duration treatment as per standard of care (treatment group 3).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- RESOLVE trial, Arm A (AML): 1. Newly diagnosed de novo AML or MDS/AML patients according to ICC 2022 or newly diagnosed AML or MDS-IB2 patients according to WHO 2022 classifications. For better readability, AML, MDS/AML or MDS-IB2 patients are generally referred to as AML patients.
- RESOLVE trial, Arm B (CLL): 4. Male patient of reproductive potential and a female partner who is of childbearing potential must agree to use highly effective methods of contraception during treatment and until 6 months after the end of the assigned trial-specific treatment
- RESOLVE trial, Arm B (CLL): 5. Female patient must agree not to breastfeed during treatment and for 18 months after the end of the assigned trial-specific treatment.
- RESOLVE trial, Arm A (AML): 2. Intermediate risk according to ELN 2022 recommendations
- RESOLVE trial, Arm B (CLL): 6. Male patient must not donate sperm during treatment and for 6 months after the end of the assigned trial-specific treatment.
- RESOLVE trial, Arm B (CLL): 7. Informed consent for registration in the MRD registry is available and the patient is registered in the MRD registry
You likely can't join if
- RESOLVE trial, Arm A (AML): 1. ELN 2022 favorable or adverse risk AML
- RESOLVE trial, Arm A (AML): 5. AML with FLT3-ITD with either high allelic ratio (>0.5) or high variant allele frequency (VAF) >33% with NPM1 wildtype at initial diagnosis
- RESOLVE trial, Arm A (AML): 6. AML with known BCR-ABL1
- RESOLVE trial, Arm A (AML): 7. Medical condition that interferes with a patient’s ability to give informed consent
- RESOLVE trial, Arm A (AML): 8. Medical or psychological condition that precludes undergoing alloHCT
- RESOLVE trial, Arm A (AML): 9. Participation in another clinical trial (other investigational drugs or devices) at the time the AML patient starts the (induction) chemotherapy or within 14 days prior to it.
See the full eligibility criteria
Who can join
- RESOLVE trial, Arm A (AML): 1. Newly diagnosed de novo AML or MDS/AML patients according to ICC 2022 or newly diagnosed AML or MDS-IB2 patients according to WHO 2022 classifications. For better readability, AML, MDS/AML or MDS-IB2 patients are generally referred to as AML patients.
- RESOLVE trial, Arm B (CLL): 4. Male patient of reproductive potential and a female partner who is of childbearing potential must agree to use highly effective methods of contraception during treatment and until 6 months after the end of the assigned trial-specific treatment
- RESOLVE trial, Arm B (CLL): 5. Female patient must agree not to breastfeed during treatment and for 18 months after the end of the assigned trial-specific treatment.
- RESOLVE trial, Arm A (AML): 2. Intermediate risk according to ELN 2022 recommendations
- RESOLVE trial, Arm B (CLL): 6. Male patient must not donate sperm during treatment and for 6 months after the end of the assigned trial-specific treatment.
- RESOLVE trial, Arm B (CLL): 7. Informed consent for registration in the MRD registry is available and the patient is registered in the MRD registry
- RESOLVE trial, Arm B (CLL): 8. Written informed consent for randomization (in the RESOLVE trial, Arm B)
- RESOLVE trial, Arm B (CLL): 9. Patient agrees not to participate in another clinical trial (other investigational drugs or devices) while participating in the RESOLVE trial
- RESOLVE trial, Arm A (AML): 3. AML patients who achieved CR, CR with incomplete hematologic recovery (CRi) or CR with partial hematologic recovery (CRh) after intensive induction therapy
- RESOLVE trial, Arm A (AML): 4. AML patients who are MFC-MRD-negative (cutoff <0.1%) in bone marrow after 1 - 2 cycles of standard induction/consolidation chemotherapy according to a certified (RESOLVE) MRD laboratory; the latest assessment must be MRD-negative
- RESOLVE trial, Arm A (AML): 5. Patients of all genders, age 18-70 years at time of registration
- RESOLVE trial, Arm A (AML): 10. Female patient must agree not to breastfeed during treatment and for 6 months after the end of the trial-specific treatment.
- RESOLVE trial, Arm A (AML): 6. Fit for alloHCT based on investigator assessment
- RESOLVE trial, Arm A (AML): 7. Suitable alloHCT donor available, who can be recruited within a short time frame (e.g. 4 weeks)
- RESOLVE trial, Arm A (AML): 8. Male and female patients of reproductive potential must agree to use highly effective methods of contraception during treatment and until 6 months after the end of the assigned treatment.
- RESOLVE trial, Arm A (AML): 9. Female patient of childbearing potential must: o Agree not to try to become pregnant during treatment and for 6 months after the end of trial-specific treatment and o have a negative urine or serum pregnancy test at screening o Unless conditions apply that exclude a pregnancy, women who have the potential to become pregnant must agree to pregnancy testing prior and during treatment in accordance with local standards.
- MRD registry, Arm A (AML): 1. Newly diagnosed de novo AML or MDS/AML patients according to ICC 2022 or newly diagnosed AML or MDS-IB2 patients according to WHO 2022 classifications. For better readability, AML, MDS/AML or MDS-IB2 patients are generally referred to as AML patients.
- MRD registry, Arm A (AML): 2. Patients of all genders, age 18-70 years
- MRD registry, Arm A (AML): 3. Scheduled for or undergoing intensive induction chemotherapy according to state of the art
- MRD registry, Arm A (AML): 4. Fit or potential to becoming fit for alloHCT
- MRD registry, Arm A (AML): 5. Unknown ELN 2022 risk or known ELN 2022 intermediate risk
- MRD registry, Arm A (AML): 6. Male and female patients of reproductive potential must agree to use effective methods of contraception adequate for the planned intervention and as per locally accepted standards.
- RESOLVE trial, Arm A (AML): 11. Male patient must not donate sperm during treatment and for 6 months after the end of the trial-specific treatment.
- MRD registry, Arm A (AML): 7. Unless conditions apply that exclude a pregnancy, women who have the potential to become pregnant must consent to undergo pregnancy testing prior to treatment in accordance with local standards. If necessary, they must also agree to additional testing throughout the treatment period.
- MRD registry, Arm A (AML): 8. Able to understand and willing to sign an informed consent form (ICF)
- MRD registry, Arm A (AML): 9. Written informed consent for registration
- MRD registry, Arm A (AML): 10. Patient agrees not to participate in another clinical trial (other investigational drugs or devices) before randomization
- MRD registry, Arm B (CLL): 1. Diagnosis of CLL or small lymphocytic lymphoma (SLL) For better readability, “CLL or SLL patients” are generally referred to as “CLL patients”.
- MRD registry, Arm B (CLL): 2. Treatment naïve CLL/SLL or undergoing first line treatment during the first 4 months of treatment
- MRD registry, Arm B (CLL): 3. Patient of all genders, age ≥ 65 years
- MRD registry, Arm B (CLL): 4. Active disease requiring treatment as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
- MRD registry, Arm B (CLL): 5. Scheduled for or undergoing treatment with a fixed-duration regimen
- MRD registry, Arm B (CLL): 6. Known immunophenotype of CLL cells that is suitable for MRD assessment (as determined in MRD assessment at registration by national MRD reference laboratory)
- RESOLVE trial, Arm A (AML): 12. Informed consent for registration in MRD registry is available and the patient is registered in the MRD registry
- MRD registry, Arm B (CLL): 7. Male patients of reproductive potential must agree to use effective methods of contraception adequate for the planned intervention and as per locally accepted standards.
- MRD registry, Arm B (CLL): 8. Able to understand and willing to sign an informed consent form (ICF)
- MRD registry, Arm B (CLL): 9. Written informed consent for registration
- MRD registry, Arm B (CLL): 10. Patient agrees not to participate in another clinical trial (other investigational drugs or devices) before randomization
- RESOLVE trial, Arm A (AML): 13. Written informed consent for randomization (in RESOLVE trial, Arm A)
- RESOLVE trial, Arm A (AML): 14. Patient agrees not to participate in another clinical trial (other investigational drugs or devices) while participating in the RESOLVE trial
- RESOLVE trial, Arm B (CLL): 1. Diagnosis of CLL or SLL. For better readability, CLL or SLL patients are generally referred to as "CLL patients"
- RESOLVE trial, Arm B (CLL): 2. Patients of all genders, age ≥ 65 years at time of registration
- RESOLVE trial, Arm B (CLL): 3. Undetectable MRD in peripheral blood according to a certified (ERIC/RESOLVE) MRD laboratory at C7D1 AND C8D1 (venetoclax + anti-CD20 MoAb (obinutuzumab)) or C9D1 AND C10D1 (venetoclax + BTKi ibrutinib). MRD negativity or uMRD prior to randomization is confirmed if MRD is undetectable at a sensitivity level of <10-4 (uMRD4 or uMRD5) at MRD1 (C7D1 or C9D1) and <10-5 (uMRD5) at MRD2 (C8D1 or C10D1).
What rules you out
- RESOLVE trial, Arm A (AML): 1. ELN 2022 favorable or adverse risk AML
- RESOLVE trial, Arm A (AML): 5. AML with FLT3-ITD with either high allelic ratio (>0.5) or high variant allele frequency (VAF) >33% with NPM1 wildtype at initial diagnosis
- RESOLVE trial, Arm A (AML): 6. AML with known BCR-ABL1
- RESOLVE trial, Arm A (AML): 7. Medical condition that interferes with a patient’s ability to give informed consent
- RESOLVE trial, Arm A (AML): 8. Medical or psychological condition that precludes undergoing alloHCT
- RESOLVE trial, Arm A (AML): 9. Participation in another clinical trial (other investigational drugs or devices) at the time the AML patient starts the (induction) chemotherapy or within 14 days prior to it.
- MRD registry, Arm A (AML): 1. Prior myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) or CML or MDS/MPN
- MRD registry, Arm A (AML): 2. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA, or other translocations associated with APL
- MRD registry, Arm A (AML): 3. Known ELN 2022 favorable or adverse risk
- MRD registry, Arm A (AML): 4. Pregnant or lactating woman
- MRD registry, Arm A (AML): 5. Medical condition that interferes with a patient’s ability to give informed consent
- RESOLVE trial, Arm B (CLL): 1. Patients with relapsed/refractory CLL
- MRD registry, Arm B (CLL): 1. Relapsed/refractory CLL after prior treatments
- MRD registry, Arm B (CLL): 2. Patients with atypical immunophenotype not suitable for MRD assessment (as determined in MRD assessment at registration by national reference laboratory)
- MRD registry, Arm B (CLL): 3. CLL with del(17p) and/or mutated TP53
- MRD registry, Arm B (CLL): 4. Medical condition that interferes with a patient’s ability to give informed consent
- RESOLVE trial, Arm B (CLL): 2. Patients with atypical immunophenotype not suitable for MRD assessment (as determined in MRD assessment at registration by national reference laboratory)
- RESOLVE trial, Arm B (CLL): 3 CLL with del(17p) and/or mutated TP53
- RESOLVE trial, Arm B (CLL): 4. Medical condition that interferes with a patient’s ability to give informed consent
- RESOLVE trial, Arm B (CLL): 5. Participation in another clinical trial (other investigational drugs or devices) at the time the CLL patient starts the fixed-duration regime or within 14 days prior to it.
- RESOLVE trial, Arm A (AML): 2. Treatment with a hypomethylating agent (with or without venetoclax)
- RESOLVE trial, Arm A (AML): 3. Prior myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) or CML or MDS/MPN
- RESOLVE trial, Arm A (AML): 4. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA, or other translocations associated with APL
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.