Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.
The primary goal in this trial is to prevent relapse. AALL1231 will test two major strategies to meet this goal: (1) to modify the existing chemotherapy platform to mirror the most efficacious backbone that has been tested in Phase 3 trials; and, (2) to randomize patients to receive/not receive a novel agent (bortezomib), with strong b
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: 1. Determine the efficac and tolerability of the combination of atezolizumab and an HMA in naive AML patients who are unfit to receive standard induction chemotherapy or relapsed/ refractory AML patients.
2. To determine the recommended Phase II dose and schedule of atezolizumab in combination with an HMA.
Grunwald, Michael Richard
Primary: 1. Determine the efficac and tolerability of the combination of atezolizumab and an HMA in naive AML patients who are unfit to receive standard induction chemotherapy or relapsed/ refractory AML patients.
2. To determine the recommended Phase II dose and schedule of atezolizumab in combination with an HMA.
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
Primary:
1.0 To obtain high quality and germline tissue from patients with myeloid hematologic malignancies in pre-malignant conditions. This material will be used for a variety of genetic analyses aimed at identification of novel mutations involved in the initiation and progression of these diseases.

Exploratory:
1.0 To sequence AML genomes for the discovery of mutations or germline variants.

2.0 To identify inherited genetic polymorphisms or mutations in germline DNA that increase susc
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
Primary: Describe current treatment patterns in the real-world setting of CLL patients who are initiating treatment with novel therapies including oral kinase inhibitors or other approved anti-CLL therapies/ regimens as 1st or later line of therapy. Explore association with baseline characteristics, healthcare resource utilization and clinical outcomes.
Secondary: Characterize adverse events (AEs) ain CLL patients in this setting. Assess patient reported HRQOL and association with therapeutic
Ghosh, Nilanjan
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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