CPX-351 (Vyxeosâ„¢) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome (NCT03572764) | Clinical Trial Compass
Active — Not RecruitingPhase 1
CPX-351 (Vyxeosâ„¢) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome
United States20 participantsStarted 2018-12-14
Plain-language summary
This is a pilot and feasibility study of transplant eligible, higher risk myelodysplastic syndrome (MDS) patients to determine the safety and tolerability of a lower -dose and higher-dose CPX-351 regimen, with secondary objectives including complete remission (CR) rates and proportion of patients proceeding to transplant.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Diagnosis of myelodysplastic syndrome (MDS) with an IPSS-R score of Intermediate, High or Very High (see Appendix A) AND ≥ 5% myeloblasts in the bone marrow.
* Age 18-70 years.
* ECOG performance status ≤ 2 (see Appendix B)
Adequate renal and hepatic function as defined below:
\*Total bilirubin ≤ 2.0 x IULN\*
* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
* Serum creatinine ≤ 2.0 mg/dL
* Note: If, in the opinition of the treatment physician, the bilirubin is elevated secondary to hemolysis or Gilbert's disease, the patient may be eligible after discussion with the Washington University PI.
* Left ventricular cardiac ejection fraction ≥ 50% by echocardiography or MUGA.
* Deemed by the treating physician to be a suitable candidate for cytotoxic induction therapy and an alloHCT candidate at the time of enrollment.
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and continuing until 30 days after the last study treatment.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* Prior treatment for MDS with disease-modifying therapy (conventional or investigational) (i.e. hypomethylator therapy, lenalidomide, or prior AML-like induction therapy intended for the therapy of MDS). Use of prior growth factor and ESA support …
What they're measuring
1
Safety and tolerability of a CPX-351 regimen in a transplant eligible, higher risk MDS population as measured by the proportion of participants who experience an adverse event by patient, type of event, and grade of event