Status:
RECRUITING
CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Collaborating Sponsors:
Jazz Pharmaceuticals
Acute Leukemia French Association
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The trial is a randomized, open-label phase II study comparing CPX-351 vs conventional intensivechemotherapy in patients with newly diagnosed de novo AML and intermediate- or adverse-risk genetics (ac...
Detailed Description
Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy characterized by clonal expansion of myeloid blasts. Interestingly comparing de novo and stringently defined secondary AMLs occu...
Eligibility Criteria
Inclusion
- 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 ≥ 50 years,
- Performance status ≤ 2 (ECOG grading),
- Patient must have adequate organ function as indicated detailed with laboratory values in the section IV of the protocol
- Female patient of childbearing potential with a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of CPX-351 or 7+3. Female patient who is not actively breastfeeding at the time of study entry.
- Female patient is either post-menopausal, free from menses for \> 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy, or agrees to not become pregnant throughout the study, starting with study screening
- Male patient agrees to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving CPX-351 or 7+3 and for 3 months after the last dose of study treatment .
- Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study.
- Patient has the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.
- Patient registered to the French Social Security.
Exclusion
- 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.
- Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
- Patient has clinically active hepatitis B or hepatitis C infection.
- Patient has a known allergy or hypersensitivity to any component of CPX-351, idarubicin or cytarabine.
- Patient with a "currently active" second malignancy, other than nonmelanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for \>1 year or are considered by their physician to be at less than 30% risk of relapse.
- Patients with clinical evidence of CNS leukemia.
- Cardiac ejection fraction \<50% or considered as abnormal by echocardiography or multi-gated acquisition (MUGA) scan.
- Patient is pregnant or breastfeeding within the projected duration of the study.
Key Trial Info
Start Date :
May 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05260528
Start Date
May 3 2023
End Date
October 1 2027
Last Update
January 30 2024
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Amiens Picardie site Sud
Amiens, France
2
CH Avignon
Avignon, France
3
CHRU Jean Minjoz
Besançon, France
4
Centre Hospitalier de Béziers
Béziers, France