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 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
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- AREN03B2 - renal tumors classification, biology and banking study,
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 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 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
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
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
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 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 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
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
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
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
PTCTC ONC1701 (End RAD): A phase II pilot trial to estimate survival after a non-total body irradiation (TBI) based on conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative,
Role: Investigator,
Pediatric Blood and Marrow Transplant Consortium,
(06/2024 - 06/2025)
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
National Marrow Donor Program® (NMDP) - 10-CBA: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications,
Role: Investigator,
National Marrow Donor Program,
(09/2024 - 09/2025)
Status: Approved