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New treatment option for MDS
Official title Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML
ClinicalTrials.gov ID: NCT04061239
What this study is testing
What is CPX-351?
CPX-351 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mds.
Also referred to as Vyxeos.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To compare the event-free survival at 2 years of CPX-351 vs. conventional care regimens before allogeneic blood cell transplantation as first line treatment in patients with higher risk MDS and oligoblastic AML.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and female adult patients, 18-75 years of age
- Diagnosis of high risk MDS including oligoblastic non-proliferative (WBC \<13 Gpt/l) AML up to 29% of bone marrow blasts
- Availability of BM blast count from central morphology
- Bone marrow blasts ≥ 5%
- IPSS score intermediate or high
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.
- WHO-2016 defined AML entities: AML with t(15;17), PML-RARA; AML with t(8;21), RUNX1-RUNX1T1, AML with inv(16)/t(16;16), CBFβ-MYH11; AML with...
- Clinical evidence of active CNS leukemia.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active"...
- Any major surgery or radiation therapy within four weeks prior screening.
See the full eligibility criteria
- Male and female adult patients, 18-75 years of age
- Diagnosis of high risk MDS including oligoblastic non-proliferative (WBC \<13 Gpt/l) AML up to 29% of bone marrow blasts
- Availability of BM blast count from central morphology
- Bone marrow blasts ≥ 5%
- 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 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
- Contraception:
- Female people 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...
- 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...
- Combined oral contraceptive pills are not recommended. It is recommended that during the study two medically accepted methods of contraception (e.g. as hormonal contraceptive methods along with a condom) apply.
- 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.
- WHO-2016 defined AML entities: AML with t(15;17), PML-RARA; AML with t(8;21), RUNX1-RUNX1T1, AML with inv(16)/t(16;16), CBFβ-MYH11; AML with biallelic CEBPA mutation; AML with mutated FLT3 or NPM1.
- Clinical evidence of active CNS leukemia.
- 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 and are considered by their...
- 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).
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent.
- Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by...
- 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...
- Hypersensitivity to cytarabine, daunorubicin or liposomal products.
- History of Wilson's disease or other copper-metabolism disorder.
- Female patients who are pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- Linz, Austria
- Salzburg, Austria
- Aachen, Germany
- Augsburg, Germany
- Berlin, Germany
- Bonn, Germany
- Chemnitz, Germany
- Cologne, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Frankfurt, Germany
- Halle, Germany
- Hanover, Germany
- Heidelberg, Germany
- Jena, Germany
- Koblenz, Germany
- Leipzig, Germany
- Mannheim, Germany
- München, Germany
+ 6 more site(s).
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Linz, Austria; Salzburg, Austria; Aachen, Germany; Augsburg, Germany; Berlin, Germany; Bonn, Germany and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.