CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 70
Updated:12/19/2018
Start Date:December 14, 2018
End Date:December 31, 2025
Contact:Meagan Jacoby, M.D., Ph.D.
Email:mjacoby@wustl.edu
Phone:314-747-7949

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A Pilot Study of CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome

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.


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:

- Direct bilirubin ≤ 1.5 x IULN

- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN

- Serum creatinine ≤ 2.0 mg/dL

- 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 is permitted.

- Currently receiving any other investigational agents.

- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to CPX-351 or other agents used in the study.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac
arrhythmia.

- History of Wilson's disease or other copper-metabolism disorder.

- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
pregnancy test within 14 days of study entry.

- Known active viral infection with human immunodeficiency virus (HIV), hepatitis B
virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of
hepatitis B virus vaccine are eligible. Patients who are seropositive for HCV but have
a negative viral load are also eligible provided that the patient has completed a
course of therapy for HCV.
We found this trial at
3
sites
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Bart Scott, M.D.
Phone: 206-667-1990
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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mi
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Seattle, WA
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Meagan Jacoby, M.D., Ph.D.
Phone: 314-747-7949
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Tampa, Florida 33612
Principal Investigator: David Sallman, M.D.
Phone: 888-663-3488
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Tampa, FL
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