Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/R… (NCT03150004) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Pharmacogenomics of Cladribine Based Salvage Chemotherapy in Patients With Relapse/Refractory and Secondary Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
Stopped: No longer have funding support to complete the pharmacogenetics component.
United States53 participantsStarted 2017-06-14
Plain-language summary
This is a prospective phase II clinical study planned to be conducted at the Medical College of Wisconsin (MCW). After meeting the study criteria and enrollment, patients will be treated with a cladribine based salvage regimen and followed at periodic intervals to determine the primary and secondary objectives.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at the time of informed consent.
✓. Morphologically documented:
✓. Subjects must meet one of the following criteria:
✓. Eastern Cooperative Oncology Group (ECOG) performance score 0-3.
✓. It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Non- sterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below.
✓. Ability to understand a written informed consent document and the willingness to sign it.
✓. Subjects must meet the following clinical laboratory criteria:
. Active infection not well controlled by antibacterial or antiviral therapy.
✕. Pregnant or breast feeding women.
✕. Participation in clinical trials with other investigational agents not included in this trial, throughout the duration of this trial. Participation of follow-up portion of another clinical trial will not exclude patient from participation.