Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory AML measured response within the first 4 cycles of treatment. Kaplan, Joel Adam
This randomized phase II/III trial is studying how well giving bortezomib and sorafenib tosylate together works in treating patients with newly diagnosed acute myeloid leukemia with or without mutations Kaplan, Joel Adam
? To find out if subjects with standard risk DS AML can be treated with less treatment and still have successful outcomes.
? To find out if subjects with high risk DS AML can be successfully treated with stronger chemotherapy.
Kaplan, Joel Adam
I. To maintain a Childhood Cancer Registry for infants, children, adolescents, and young adults with cancer.

II. To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto Children's Oncology Group (COG) therapeutic clinical trials.

III. To develop a well annotated childhood cancer biobank for current and future research through the collection of biospe
Kaplan, Joel Adam
Primary
Part I: Evaluate efficacy and safety of imetelstat in transfusion dependent subjects with low/ intermediate-I risk MDS that is relapsed/ refratory to ESA treatment.
Part I: To compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in tranfusion dependent subjects with low or intermediate-I risk MDS that is relapsed/ refractory to ESA treatment.
Grunwald, Michael Richard
Primary objective: To compare two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML) with detectable leukemia stem cells (LSCs) in their bone marrow at end of treatment (eLSC+) to the two-year RFS of patients without detectable LSCs (eLSC-).

Secondary objectives:
a. Compare the one-year RFS of AML patients with detectable LSCs in their bone marrow at eLSC to the one-year RFS of AML patients without detectable LSCs at eLSC.
b. Compare the two-year RFS of favor
Grunwald, Michael Richard
Primary:
To collect high quality specimens from patients with hematologic disorders and normal volunteers.
Exploratory:
Future specimen analyses will be performed to determine the differences between sick and normal cells. Data used for these comparisons will include, but are not limited to: gene expression data, DNA, RNA, epigenetics, proteomics, metabolomics, and pathway analysys.
Avalos, Belinda Rene
The primary objective of this study is to examine the incidence of neutrophil recovery of > or = to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed. Huo, Jeffrey
To determine the maximal tolerated dose (MTD) and/or tolerable dose of escalating doses of clofarabine starting from 20mg/m2/day to 40mg/m2/day from Day 1 to Day 5 in combination with mitoxantrone 12mg/m2/day on Day 3-6 as reinduction therapy for children, adolescents and young adults with poor risk refractory/relapsed acute leukemia or high grade NHL. Oesterheld, Javier E
To determine the impact that abatacept will make on the incidence of early, severe acute GVHD (aGvHD), when it is added to a standard GvHD prophylaxis regimen during unrelated-donor hematopoietic stem cell transplantation (HSCT) for patients with hematologic malignancies. Huo, Jeffrey
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