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CPX-351 versus intensive chemotherapy in patients with de novo intermediate or adverse risk AML stratified by genomics
EU CTIS ID: 2022-500295-60-00
What this study is testing
To demonstrate an improvement in the proportion of patients achieving deep remission (Complete Remission (CR)/ Complete Remission with incomplete hematologic recovery (CRi)) with a standardized flow based MRD threshold < 10-3 in the bone marrow aspirate using the LAIP/Dfn method after the first course of treatment induction in the experimental arm (induction by CPX-351) and in the control arm (induction by 3+7, idarubicine and cytarabine).
- Therapeutic exploratory (Phase II)
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
- De novo AML
- No MRC-defining cytogenetic lesion
- No t(15;17), t(8;21), inv(16) or t(16;16)
- No NPM1 gene mutation
- No FLT3 mutated AML (FLT3 ITD or TKD)
- Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms,
You likely can't join if
- Prior history of documented MDS, MPN or MDS/MPN, tAML
- Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer)
- Patient has active and uncontrolled infection.
- Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance.
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug.
See the full eligibility criteria
- De novo AML
- No MRC-defining cytogenetic lesion
- No t(15;17), t(8;21), inv(16) or t(16;16)
- No NPM1 gene mutation
- No FLT3 mutated AML (FLT3 ITD or TKD)
- Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms,
- Age above or equal to 50 years
- Performance status below or equal to 2 (ECOG grading),
- Prior history of documented MDS, MPN or MDS/MPN, tAML
- Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer)
- Patient has active and uncontrolled infection.
- Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance.
- Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug.
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.
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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.