Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation Contacts General Inquiries Christina Baggott, RN, PhD [email protected] AML, ALL Catherine Aftandilian, MD, MS [email protected] Norman Lacayo, MD [email protected] Gary Dahl, MD [email protected] Bone and Soft Tissue Sarcomas, Sheri Spunt, MD, MBA [email protected] Renal Tumors HLH Michael Jeng, MD [email protected] Hodgkin’s Lymphoma Michael Link, MD [email protected] Immunotherapy Crystal Mackall, MD [email protected] Kara Davis, DO [email protected] Liver Tumors, Germ Cell Tumors Arun Rangaswami, MD [email protected] Neuroblastoma Robbie Majzner, MD [email protected] Neuro-Oncology Sonia Partap, MD [email protected] Paul Fisher, MD [email protected] Cynthia Campen, MD [email protected] Michelle Monje, MD [email protected] Non-Hodgkin’s Lymphoma Sandra Luna-Fineman, MD [email protected] Stem Cell Transplantation Maria Grazia Roncarolo, MD [email protected] Rajni Agarwal-Hashmi, MD [email protected] Oncology: Leukemia/Lymphoma NCT #/Phase Title Sponsor Investigator Contact Phase I TINI: Total Therapy for Infants with Acute Lymphoblastic St. Jude Norman Christina (NCT02553460) Leukemia (ALL) Lacayo Baggott, PhD, baggott@ stanford.edu Phase II HLHR13: Testing the Substitution of Brentuximab Vedotin for St. Jude Michael Christina (NCT01920932) Vincristine in the Usual Chemotherapy and Radiation in High-Risk Link Baggott, PhD, Pediatric Hodgkin Lymphoma baggott@ stanford.edu 725 Welch Rd, Palo Alto, CA 94304 | (650) 497-8953 | basscenter.stanfordchildrens.org 029584 | 05/2017 Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation 2 NCT #/Phase Title Sponsor Investigator Contact Phase II AAML1522: A Phase II, Multicenter, Single-arm, Open-label Study to COG Sheri Spunt Christina (NCT02538965) Evaluate the Activity, Safety and Pharmacokinetics of Lenalidomine Baggott, PhD, in Pediatric Subjects from 1 to 18 Years of Age with Relapse/ baggott@ Refractory Acute Myeloid Leukemia stanford.edu Phase I/II SELHEM: A Phase I/II Study of the Selective Inhibitor of Nuclear St. Jude Norman Christina (NCT02212561) Export Selinexor (KPT-330) in Combination with Fludarabine Lacayo Baggott, PhD, and Cytarabine in Pediatric Patients with Refractory or Relapsed baggott@ Leukemia or Myelodysplastic Syndrome stanford.edu Phase I PANAML: A Phase I and Dose Expansion Cohort Study Of St. Jude Norman Christina (NCT02676323) Panobinostat in Combination with Fludarabine and Cytarabine Lacayo Baggott, PhD, In Pediatric Patients with Refractory Or Relapse Acute Myeloid baggott@ Leukemia or Myelodysplastic Syndrome stanford.edu Phase I/II LYM3003: A Randomized, Open-label, Safety and Efficacy Study Janssen Michael Christina (NCT02703272) of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Link Baggott, PhD, Refractory Mature B-cell non-Hodgkin Lymphoma baggott@ stanford.edu Phase II ANHL12P1: A Randomized Phase II Trial of Brentuximab Vedotin or COG Sheri Spunt Christina (NCT01979536) Crizotinib in Combination with Chemotherapy for Newly Diagnosed Baggott, PhD, Patients with Anaplastic Large Cell Lymphoma (ALCL) baggott@ stanford.edu Phase I POE-14: Phase I Study of Carfilzomib in combination with POETIC Norman Christina (NCT02512926) Cyclophosphamide and Etoposide for Children with Relapsed or Lacayo Baggott, PhD, Refractory Solid Tumors and Leukemias baggott@ stanford.edu Phase II CCTL019B2205J: A Phase II, single arm, multicenter trial to Novartis Kara Davis Christina (NCT02228096) determine the efficacy and safety of CTL019 in pediatric patients Baggott, PhD, with relapsed and refractory B-cell acute lymphoblastic leukemia baggott@ stanford.edu Part of 2205J CCTL019B2206: A multicenter study of apheresis collection of Novartis Kara Davis Christina peripheral blood mononuclear cells (PBMC) in patients with CD19 Baggott, PhD, expressing malignancies who could be eligible for a CTL019 clinical baggott@ research trial stanford.edu Phase II (planned AHOD1721: Risk-based, response-adapted, Phase II open-label COG/BMS Sheri Spunt Christina to open 6/17) trial of nivolumab + brentuximab vedotin (N+ Bv) for children, Baggott, PhD, adolescents,and young adults with relapsed/refractory (R/R) baggott@ CD30 + classic Hodgkin lymphoma (cHL)after failure of first- stanford.edu linetherapy,followed by brentuximab + bendamustine (Bv + B) for participantswith a suboptimal response. CheckMate 744: CHECKpoint pathway and nivolumab clinical Trial Evaluation 725 Welch Rd, Palo Alto, CA 94304 | (650) 497-8953 | basscenter.stanfordchildrens.org 029584 | 05/2017 Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation 3 Oncology: Immunotherapy NCT #/Phase Title Sponsor Investigator Contact Phase I Macrogenics: A Phase 1, Open-label, Dose Escalation Study of Macro- Crystal Christina (NCT02475213) MGA271 in Pediatric Patients with B7-H3-Expressing Relapsed or Genics Mackall Baggott, PhD, Refractory Solid Tumors baggott@ stanford.edu Phase II Novartis 2205J: A Phase II, single arm, multicenter trial to determine Novartis Kara Davis Christina (NCT02228096) the efficacy and safety of CTL019 in pediatric patients with relapsed Baggott, PhD, and refractory B-cell acute lymphoblastic leukemia baggott@ stanford.edu Oncology: Neuro-Oncology NCT #/Phase Title Sponsor Investigator Contact Phase II/III SJATRT: Phase 2 Study Of Alisertib as a Single Agent in Recurrent St. Jude Sonia Christina (NCT02114229) or Progressive Central Nervous System (CNS) Aypicial Teratoid Partap Baggott, PhD, Rhabdoid Tumors (AT/RTs) and Extra-CNS Malignant Rhabdoid baggott@ Tumors (MRTs) and in Combination Therapy in Newly Diagnosed stanford.edu AT/RT Phase II/III SJMB12: A Clinical and Molecular Risk-Directed Therapy for Newly St. Jude Sonia Christina (NCT01878617) Diagnosed Medulloblastoma Partap Baggott, PhD, baggott@ stanford.edu Phase I/II PBTC-029B: A Phase I and Phase II and Re-Treatment Study of PBTC Paul Fisher Christina (NCT01089101) AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma Baggott, PhD, baggott@ stanford.edu Phase I/II PBTC-042: Phase I study of CDK 4-6 inhibitor PD-0332991 in PBTC Paul Fisher Christina (NCT02255461) children with recurrent, progressive or refractory central nervous Baggott, PhD, system tumors baggott@ stanford.edu Phase I/II PBTC-045: A Safety and Preliminary Efficacy trial of MK-3475 PBTC Paul Fisher Christina (NCT02359565) (pembrolizumab; anti-PD-1) in Children with recurrent, progressive Baggott, PhD, or refractory high-grade gliomas (HGG), DIPGs and hypermutated baggott@ brain tumors stanford.edu Phase I/II PBTC-047: Phase 1 Trial of Panobinostat in Children with Diffuse PBTC Paul Fisher Christina (NCT02717455) Intrinsic Pontine Glioma Baggott, PhD, baggott@ stanford.edu Phase II INTELLANCE 2: ABT-414 alone or ABT-414 plus temozolomide versus AbbVie Sonia Christina (NCT02343406) lomustine or temozolomide for recurrent glioblastoma: a randomized Partap Baggott, PhD, phase II study of the EORTC Brain Tumor Group baggott@ stanford.edu 725 Welch Rd, Palo Alto, CA 94304 | (650) 497-8953 | basscenter.stanfordchildrens.org 029584 | 05/2017 Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation 4 Oncology: Solid Tumors NCT #/Phase Title Sponsor Investigator Contact Phase II NANT 2011-01: A Randomized Phase II Study of 131-1-MIBG vs 131-1- NANT Sheri Spunt Christina (NCT02035137) MIBG with Vincristine and Irinotecan vs 131-1-MIBG with Vorinostat Baggott, PhD, for Resistant/Relapsed Neuroblastoma baggott@ stanford.edu Phase I NANT2011-04: A Phase I Study of Lenalidomide and Anti-GD2 Mab NANT Sheri Spunt Christina (NCT01711554) CH14.18 +/- Isotretinoin in Patients with Refractory/Recurrent Baggott, PhD, Neuroblastoma baggott@ stanford.edu Phase I NANT2012-01: A Phase I Study of Difluoromethylornithine (DFMO) NANT Sheri Spunt Christina (NCT02030964) and Celecoxib Cyclophosphamide/Topotecan for Patients with Baggott, PhD, Relapsed or Refractory Neuroblastoma baggott@ stanford.edu Phase I NANT 2013-01: Immunotherapy of Relapsed Neuroblastoma with NANT Sheri Spunt Christina (NCT02573896) expanded NK cells, Lenalidomide and ch14.18 Baggott, PhD, baggott@ stanford.edu Phase I NANT 2013-02: A Phase I Study of Sorafenib and NANT Sheri Spunt Christina (NCT02298348) Cyclophosphamide/Topotecan in Patients with Relapsed and Baggott, PhD, Refractory Neuroblastoma baggott@ stanford.edu Phase I NANT 2014-01: Phase I Study of SF1126 for Patients with Relapsed NANT Sheri Spunt Christina (NCT02337309) or Refactory Neuroblastoma Baggott, PhD, baggott@ stanford.edu Phase I/II NANT 2015-02: Phase 1/2 Study of PF-06463922, an Oral Small NANT Sheri Spunt Christina Molecule Inhibitor of ALK/ROS1, for patients with Alk-Driven Baggott, PhD, Relapsed or Refractory Neurblastoma baggott@ stanford.edu Phase I/II LOXO: A Phase 1/2 Study of the Oral TRK Inhibitor LOXO 101 in Loxo Sheri Spunt Christina (NCT02637687) Pediatric Patients with Advanced Solid or Primary Central Nervous Baggott, PhD, System Tumors baggott@ stanford.edu Phase II ADVL1322: A Phase II Study of Pazopanib (GW786034, NSC# COG Sheri Spunt Christina (NCT02452554) 737754) in Children, Adolescents and Young Adults with Refractory Baggott, PhD, Solid Tumors baggott@ stanford.edu Phase I/II ADVL1412: A Phase 1/2 Study of Nivolumab (IND# 124729) COG Sheri Spunt, Christina (NCT02304458) in Children, Adolescents, and Young Adults with Recurrent or Crystal Baggott, PhD, Refractory