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Comparison of therapies before stem cell transplantation in patients with higher risk MDS and oligoblastic AML
EU CTIS ID: 2024-515375-35-00
What this study is testing
To compare event-free survival (EFS) of CPX-351 vs. CCR before allogeneic blood cell transplantation (alloHCT) as first line treatment in patients with higher risk MDS and oligoblastic AML.
- 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
- Adult patients (irrespective of sex), 18-75 years of age
- Contraception: - Female subjects of childbearing potential† must agree to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351; Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351 and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351
- Diagnosis of high risk MDS including oligoblastic non-proliferative (WBC <13 Gpt/l) AML up to 29% of bone marrow blasts
- Bone marrow blasts ≥ 5% (central morphology Düsseldorf)
- IPSS score intermediate or high
- alloHCT intended within the next 6 months
You likely can't join if
- Patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
- Creatinine clearance < 30 ml/min.
- Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥ 72 hrs.
- Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values).
- Hypersensitivity to cytarabine, daunorubicin or liposomal products.
- History of Wilson’s disease or other copper-metabolism disorder, unless the therapy outweighs the risks.
See the full eligibility criteria
Who can join
- Adult patients (irrespective of sex), 18-75 years of age
- Contraception: - Female subjects of childbearing potential† must agree to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351; Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351 and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351
- Diagnosis of high risk MDS including oligoblastic non-proliferative (WBC <13 Gpt/l) AML up to 29% of bone marrow blasts
- Bone marrow blasts ≥ 5% (central morphology Düsseldorf)
- IPSS score intermediate or high
- alloHCT intended within the next 6 months
- ECOG performance status of 0 or 1
- Signed informed consent
- Laboratory values fulfilling all of the following: Serum creatinine < 2.0 mg/dL; Serum total bilirubin < 2.0 mg/dL; Serum alanine aminotransferase or aspartate aminotransferase < 3 times the ULN
- Cardiac ejection fraction (LVEF) ≥ 50% by echocardiography
What rules you out
- Patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
- Creatinine clearance < 30 ml/min.
- Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ≥ 72 hrs.
- Current evidence of invasive fungal infection (blood or tissue culture); patients with recent fungal infection must have a subsequent negative cultures to be eligible; known HIV (new testing not required) or evidence of active hepatitis B or C infection (with rising transaminase values).
- Hypersensitivity to cytarabine, daunorubicin or liposomal products.
- History of Wilson’s disease or other copper-metabolism disorder, unless the therapy outweighs the risks.
- Female patients who are pregnant or lactating.
- WHO-2016 defined AML entities: AML with t(15;17), PMLRARA; AML with t(8;21), RUNX1-RUNX1T1, AML with inv(16)/t(16;16), CBFβ-MYH11; AML with BCR-ABL1, AML with biallelic CEBPA mutation; AML with mutated FLT3 or NPM1.
- Clinical evidence of active CNS leukaemia.
- Patients with a “currently active” second malignancy other than non-melanoma skin cancers. Patients are not considered to have a “currently active” malignancy if they have completed therapy more than 2 years ago and are disease free.
- Any major surgery or radiation therapy within four weeks prior screening.
- Patients with prior treatment of either CPX-351, hypomethylating agents, cytarabine or intensive chemotherapy for high-risk MDS or AML.
- Patients with prior cumulative anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent).
- Recent (< 30 days) or planned live vaccinations during the clinical trial.
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent.
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.