Carolinas HealthCare System

Research and Clinical Trials

Brief Description Principal Investigator
The primary objectives are as follows:
 To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of AGEN1884 in subjects with advanced or metastatic cancer (solid tumors or lymphoma) including but not limited to carcinoma, sarcoma, malignant glioma, or melanoma.
 To determine the maximum tolerated dose (MTD).
 To evaluate the pharmacokinetics (PK) of AGEN1884 in subjects with advanced or
metastatic solid tumors.
Hwang, Jimmy John
The primary objectives are as follows:
 To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of AGEN1884 in subjects with advanced or metastatic cancer (solid tumors or lymphoma) including but not limited to carcinoma, sarcoma, malignant glioma, or melanoma.
 To determine the maximum tolerated dose (MTD).
 To evaluate the pharmacokinetics (PK) of AGEN1884 in subjects with advanced or
metastatic solid tumors.
Hwang, Jimmy John
To describe the anti-tumor activity (efficacy) and toxicity (safety) of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced solid tumors, multiple myeloma or B cell non-Hodgkin lymphoma with a genomic variant known (i) to be a target of an FDA-approved anti-cancer drug or (ii) to predict sensitivity to an FDA-approved anti-cancer drug. Kim, Edward Sanghyun
Primary: Evaluate the safey and tolerability of the combination of nivolumab and brentuximab in subjects with the diagnosis of relapsed, refractory DLBCL, PTCL, and CTCL.
To assess the clinical benefit of nivolumab and brentuximab vedotin combination regimen in subjects with diagnosis of relapsed/ refractory DLBCL, relapsed/ refractory DLBCL, relapsed/ refractory PTCL, (excluding ALCL) and relapsed/ refractory CTCL, as measured by ORR, and portion of patients achieving PR or CR.
Ghosh, Nilanjan
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
Objectives and Outcome Measures
This study will evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of induction treatment consisting of atezolizumab in combination with obinutuzumab plus lenalidomide (Atezo +G+ Len) in patients with relapsed or refractory follicular lymphoma (FL), followed by maintenance treatment with Atezo +G+ Len in patients who achieve a complete response (CR), a partial response (PR), or stable disease at end of induction (EOI). Specific objectives and cor
Ghosh, Nilanjan
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
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 safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline (doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy backbone (Immunochemotherapy). Oesterheld, Javier E
To evaluate the efficacy of ibrutinib in combination with lenalidomide with or without rituximab by assessing the overall response in subjects with relapsed or refractory non-GCB DLBCL. 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
Primary: To assess the efficacy of TGR-1202 alone and in combination with ublituximab in patients with previously treated DLBCL measured by overall response rate (ORR).
Secondary: Assess efficacy of TGR-1202 alone and in combination with ublituximab in patiets with previously treated DLBCL as measured by progression free survival (PFS) at month 6.
Ghosh, Nilanjan
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