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Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
Primary Aims
1. To compare disease free survival (DFS) of high risk (HR) and intermediate risk (IR) relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy (standard chemotherapy) to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization).

2. To compare DFS of low risk (LR) relapse B-ALL patients who are randomized following Block 1 chemotherapy (standard chemotherapy) to receive either chemotherapy alone or che
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
To determine the maximum tolerated dose (MTD), the dose limiting toxicities(DLT) and the dose of FT-1101 recommended for future phase 2 studies (RP2D) for patients with relapsed refractory acute leukemia or high-risk MDS. 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
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
Phase 1b
Primary Objectives
1. To assess the safety and tolerability of carfilzomib, alone and in combination with induction chemotherapy, for the treatment of children with relapsed or refractory acute lymphoblastic leukemia (ALL)

2. To determine the maximum tolerated dose (MTD) of carfilzomib in combination with induction chemotherapy

Phase 2
Primary Objective
1. To estimate the combined rate of bone marrow complete response (CR) and bone marrow CR without platelet recovery (CRp) at
Oesterheld, Javier E
To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia at one and two-years following allogeneic HCT for hematologic malignancy. Huo, Jeffrey
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
Primary: To determine the overall response rate (ORR) defined as the sum of complete responses (CR) and partial responses (PR).
Secondary: To evaluate the progression-free survival (PFS) and duration of response (DOR). TO evaluate the percent of patients that achieve MRD negativity. TO evaluate the safety of ublituximab in combination with TGR-1202.
Jacobs, Ryan
Primary: To establish that the combination of ublituximab + TGR-1202 is superior
to the combination of obinutuzumab + chlorambucil as measured by
Progression-Free Survival (PFS) in patients with CLL
Secondary:
To establish that the combination of ublituximab + TGR-1202 provides
clinical benefit over both ublituximab alone and TGR-1202 alone.
To evaluate and compare the combination of ublituximab + TGR-1202 to
the combination of obinutuzumab + chlorambucil with respect to overall
respons
Jacobs, Ryan
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