Research Projects & Grants

College/University

• POEM: A PrOspective Registry of Pediatric Cellular Therapy Patients at risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS), Role: Investigator, Duke University, (12/2024 - 12/2025) Status: Approved

Federal

• COG-APEC14B1: project: EveryChild - a registry, eligibility screening, biology and outcome study, Role: Investigator, Children Oncology Group, (09/2024 - 09/2025) Status: Approved
• COG A031102: a randomized phase III trial comparing conventional-dose chemotherapy using paclitaxel, ifosfamide, and cisplatin (TIP) with high-dose chemotherapy using mobilizing paclitaxel plus Ifosfamide followed by high-dose carboplatin and etoposide (TI-CE) as first salvage treatment in relapsed or refractory germ cell tumors, Role: Investigator, Children Oncology Group, (09/2024 - 09/2025) Status: Approved
• COG AAML 1921 / ITCC-054: A Phase I/II study of Bosutinib in pediatric patients with newly diagnosed chronic phase or resistant/intolerant Ph+ Chronic Myeloid Leukemia, Role: Investigator, Children Oncology Group, (08/2024 - 08/2025) Status: Approved
• COG AALL1631: International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones, Role: Investigator, Children Oncology Group, (07/2024 - 07/2025) Status: Approved
• COG ACNS1422: A Phase 2 Study of reduced therapy for newly diagnosed average-risk WNT-driven medulloblastoma patients, Role: Investigator, Children Oncology Group, (06/2024 - 06/2025) Status: Approved
• TSLP and pediatric leukemia mechanisms and treatment, Role: Investigator, National Cancer Institute/NIH/DHHS, (06/2024 - 06/2025) Status: Approved
• COG - AALL03B1 - Classification of Acute Lymphoblastic Leukemia consent for collection of additional bone marrow, Role: Investigator, Children Oncology Group, (06/2024 - 07/2024) Status: Completed
• COG AALL1621: phase 2 study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in children and young adults with relapsed or refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL), Role: Investigator, Children Oncology Group, (06/2024 - 06/2025) Status: Approved
• COG - ACCRN07: Protocol for the Enrollment on the Official Registry, the Childhood Cancer Research Network (CCRN)., Role: Investigator, Children Oncology Group, (06/2024 - 06/2025) Status: Approved
• COG-ANBL00B1 Neuroblastoma biology studies Revised 11/30/2000, Role: Investigator, Children Oncology Group, (03/2025 - 03/2026) Status: Approved
• COG ARST1431: A randomized phase 3 study of vincristine, dactinomycin, cyclophosphamide (VAC) alternating with vincristine and irinotecan (VI) versus VAC/VI plus temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in patients with intermediate risk (IR) rhabdomyosarcoma (RMS), Role: Investigator, Children Oncology Group, (03/2025 - 03/2026) Status: Approved
• COG AEWS1221: Randomized phase 3 trial evaluating the addition of the IGF-1R monoclonal antibody ganitumab (AMG 479, NSC# 120449) to multiagent chemotherapy for patients with newly diagnosed metastatic Ewing sarcoma, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG AAML1331: A phase III study for patients with newly diagnosed acute promyelocytic Leukemia (APL) using arsenic trioxide and all trans-retinoic acid, Role: Investigator, Children Oncology Group, (02/2025 - 02/2026) Status: Approved
• Children's Oncology Group (COG)-AALL0932: Treatment of patients with newly diagnosed standard risk B-precursor acute lymphoblastic leukemia (ALL) or localized B-lineage lymphoblastic lymphoma (B-LLy), Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG - ACNS0334: A phase III randomized trial for the treatment of newly diagnosed supratentorial PNET and high risk medulloblastoma in children < 36 months old with intensive induction chemotherapy with methotrexate followed by consolidation with stem cell rescue vs. the same therapy without methotrexate, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• Children's Oncology Group (COG) - ACNS0831: Phase III randomized trial of post-radiation chemotherapy in patients with newly diagnosed ependymoma ages 1 to 21 years, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• Children's Oncology Group (COG) - AEWS1031: A phase III randomized trial of adding vincristine-topotecan-cyclophosphamide to standard chemotherapy in initial treatment of non-metastatic Ewing sarcoma, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG-AAML1031: A phase III randomized trial for patients with de novo AML using Bortezomib (IND# 58443, NSC#681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for patients with high allelic ratio FLT3/ITD, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B- Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND #73789, NSC #732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG AALL1231: A phase III randomized trial investigating Bortezomib (NSC#681239; IND#58443) on a modified augmented BFM (ABFM) backbone in newly diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy), Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• Children's Oncology Group (COG) AALL1331: Risk-stratified randomized phase III testing of blinatumomab (IND#117467, NSC#765986) in first relapse of childhood B-Lymphoblastic Leukemia (B-ALL), Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG AHOD 1331: randomized phase III study of Brentuximab Vedotin (SGN-35, IND #117117) for newly diagnosed high-risk classical Hodgkin Lymphoma (cHL) in children and adolescents, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG AGCT1531: A phase 3 study of active surveillance for low risk and a randomized trial of carboplatin vs. cisplatin for standard risk pediatric and adult patients with germ cell tumors, Role: Investigator, Children Oncology Group, (02/2025 - 02/2026) Status: Approved
• COG: AALL0434 - Intensified methotrexate, nelarabine (compound 506U78; IND# 52611) and augmented BFM therapy for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia or T-Cell Lymphoblastic Lymphoma, Role: Investigator, Children Oncology Group, (01/2025 - 03/2025) Status: Completed
• COG-ACNS0332: A study evaluating the efficacy of carboplatin administered concomitantly with radiation and isotretinoin as a pro-apoptotic agent in other than average risk medulloblastoma/PNET patients, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• Children's Oncology Group (COG) - AALL0631: A Phase III study of risk directed therapy for infants with acute lymphoblastic leukemia (ALL): Randomization of highest risk infants to intensive chemotherapy +/- FLT3 inhibition (CEP-701, lestaurtinib; IND#76431; NSC#617807), Role: Investigator, Children Oncology Group, (02/2024 - 07/2024) Status: Completed
• COG- AHOD0831: A non-randomized phase III study of response adapted therapy for the treatment of children with newly diagnosed high risk Hodgkin's Lymphoma, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG-AREN0534: Treatment for patients with bilateral, multicentric, or bilaterally-predisposed unilateral Wilms tumor, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG - ANBL0032 - Phase III randomized study of Chimeric antibody 14.18 (Ch14.18) in high risk Neuroblastoma following Myeloablative Therapy and autologous stem cell rescue, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• COG: AREN0533 - Treatment of newly diagnosed higher risk favorable histology Wilms tumors, Role: Investigator, Children Oncology Group, (01/2025 - 01/2026) Status: Approved
• Children's Oncology Group (COG) - ALTE05N1: Umbrella long-term follow-up protocol, Role: Investigator, Children Oncology Group, (11/2024 - 11/2025) Status: Approved
• COG AAML1531: Risk-stratified therapy for acute myeloid leukemia in Down Syndrome, Role: Investigator, Children Oncology Group, (10/2024 - 10/2025) Status: Approved
• Children's oncology group (COG)-AALL08B1: Classification of newly diagnosed acute lymphoblastic leukemia (ALL), Role: Investigator, Children Oncology Group, (10/2023 - 10/2024) Status: Completed
• Children's Oncology Group (COG) - AAML08B1: biology study of Transient Myeloproliferative Disorder (TMD) in children with Down Syndrome (DS), Role: Investigator, Children Oncology Group, (05/2023 - 05/2024) Status: Completed
• Children’s Oncology Group (COG) protocol AOST06B1 – collecting and banking osteosarcoma specimens, Role: Investigator, Children Oncology Group, (05/2023 - 05/2024) Status: Completed
• COG AOST1421: A phase 2 study of human-mouse chimeric anti-disialoganglioside monoclonal antibody ch14.18 (Dinutuximab, NSC #764038, IND #4308) in combination with sargramostim (GM-CSF) in patients with recurrent osteosarcoma, Role: Investigator, Children Oncology Group, (03/2023 - 03/2024) Status: Completed
• COG – ARST0332: Risk-Based Treatment for Non-Rhabdomyosarcoma Sort Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age, Role: Investigator, Children Oncology Group, (03/2023 - 02/2024) Status: Completed
• COG-ANBLOOP3 - A Phase II/III study of the use of intravenous gammaglobulin therapy for patients with neuroblastoma associated opsoclonus-myoclonus-ataxia syndrome, Role: Investigator, Children Oncology Group, (04/2022 - 04/2023) Status: Completed
• COG: ARST 0531 - Randomized study of vincristine, dactinomycin and cyclophosphamide (VAC) versus VAC alternating with vincristine and ironotecan (VI) for patients with intermediate-risk rhabdomyosarcoma (RMS), Role: Investigator, Children Oncology Group, (04/2022 - 04/2023) Status: Completed
• COG ACCL 1333 / BMS CV185-155: a phase III randomized, open label, multi-center study of the safety and efficacy of apixaban for thromboembolism prevention versus no systemic anticoagulant prophylaxis during induction chemotherapy in children with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoma (T or B cell) treated with Pegylated (PEG) L-asparaginase, Role: Investigator, Children Oncology Group, (10/2021 - 10/2022) Status: Completed
• COG ADVL1722 / Eisai E7389-G000-223:A phase 2, multicenter, open-label study to assess safety and preliminary activity of eribulin mesylate in pediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS), Role: Investigator, Children Oncology Group, (01/2021 - 01/2022) Status: Completed
• COG AAML1321/Novartis CAMN107A2203: A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistance or intolerant to either imatibib or dasatinib, Role: Investigator, Children Oncology Group, (02/2020 - 02/2021) Status: Completed

For Profit Organization

• COG ADVL1822/ Daiichi Sankyo, Inc. AC220-A-U202: A Phase 1/2, Multicenter, Dose-Escalating study to evaluate the safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Quizartinib administration in combination with re-induction chemotherapy, and as a single-agent continuation therapy, in pediatric relapsed/refractory AML subjects ages 1 month to <18 years (and Young adults ages up to 21 years) with FLT3-ITB mutations, Role: Investigator, Daiichi Sankyo Pharma Development, (06/2024 - 06/2025) Status: Approved
• CCG D9902 A group wide protocol for collecting and banking pediatric cancer research specimens. An intergroup rhabdomyosarcoma study group protocol., Role: Investigator, Children Cancer Group, (05/2023 - 05/2024) Status: Completed
• EAP-Oncoceutics-ONC018: Expanded access to ONC201 for patients with H3 K27M-mutant and/or midline high grade gliomas, Role: Investigator, Oncoceutics, Inc., (10/2022 - 10/2023) Status: Completed
• Jazz Pharmaceuticals JZP458-201 (COG AALL1931): An open-label, multicenter study of RC-P in patients with acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL) following hypersensitivity to E. coli-derived asparaginases, Role: Investigator, Jazz Pharmaceuticals, (01/2022 - 01/2023) Status: Completed
• Pfizer B0661037: A randomized, open-label, active controlled, safety and descriptive efficacy study in pediatric subjects requiring anti-coagulation for the treatment of a venous thromboembolic event, Role: Investigator, Pfizer Inc., U.S. Pharmaceuticals Group, (11/2021 - 11/2022) Status: Completed

Foreign

• Pediatric blood and marrow transplant consortium (PBMTC) and Canadian Institutes of Health Research (CIHR) - GVHD-1202: Predictive biomarkers for pediatric chronic graft-versus-host disease, Role: Investigator, Canadian Institutes of Health Research, (09/2024 - 09/2025) Status: Approved

Internal

• Using Virtual Reality to Alleviate Pain and Anxiety in Pediatric Oncology Patients, Role: PI, LLU Dept. of Pediatrics, (10/2022) Status: Approved
• Hematological Manifestations and Complications in Hospitalized Children with SARS-CoV-2 Infection, Role: PI, LLU Dept. of Pediatrics, (07/2021) Status: Approved
• Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with COVID-19 Infection: An Institutional Experience, Role: Investigator, LLU Dept. of Pediatrics, (03/2021) Status: Approved
• LLU Cancer Center biospecimen laboratory - specimens collection protocol, Role: Investigator, LLU Cancer Institute, (09/2024 - 09/2025) Status: Approved

Non-Profit Organization

• The National Marrow donor Program (NMDP) and Center for International Blood and Marrow Transplant Research (CIBMTR) - Contribution of a Blood Sample to the National Marrow Donor Program's Research Sample Repository, Role: Investigator, National Marrow Donor Program, (09/2024 - 09/2025) Status: Approved
• NMDP and CIBMTR - Protocol for Research Database for Hematopoietic Stem Cell Transplantation and Marrow Toxic Injuries., Role: Investigator, National Marrow Donor Program, (06/2024 - 06/2025) Status: Approved