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. Eckrich, Michael James
To report the incidence of chronic kidney disease (CKD), metabolic syndrome, and osteopenia at one and two-years following allogeneic HCT for hematologic malignancy. Eckrich, Michael James
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
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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