Carolinas HealthCare System

Research and Clinical Trials

Leukemia, other 

Brief Description Principal Investigator
To evaluate the safety and tolerability of AMG 232.
To determine the maximum-tolerated dose (MTD) of AMG 232.
To define the pharmacokinetics (PK) of AMG 232 in subjects with relapsed/refractory acute myelois leukemias (AMLs).
Grunwald, Michael Richard 
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: Evaluate spleen response rate and symptom response rate of 2 dose regimens of imetelstat in subjects with intermediate-2 or high-risk MF who are relapsed after or refractory to JAK inhibitor treatment. Grunwald, Michael Richard 
To determine the ability of CD34+ cell selection using the CliniMACS® device as the sole
GVHD prophylaxis to prevent severe (grade III-IV) acute GVHD in recipients of
alternative donor (mismatched related donor and unrelated donor) hematopoietic stem
cell transplants.
Gilman, Andrew Lee 
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. Gilman, Andrew Lee 
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. Gilman, Andrew Lee 
Primary: Evaluate antitumor activity in patients with previously treated CLL
Secondary: Evaluate addition of ublituximab to ibrutinib on complete response, minimal residual disease negativity (MRD)and effect on safety profile. This study will also evaluate progression free survival.
Ghosh, Nilanjan 
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