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Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation

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Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation Contacts Stefania Chirita [email protected] General Inquiries: Oncology Liza Reichert [email protected] General Inquiries: Hematology Liza Reichert [email protected] General Inquiries: SCTIntakeCoordinators@ Alex Palau Charles, RN Stem Cell Transplantation stanfordchildrens.org Catherine Aftandilian, MD, MS [email protected] AML, ALL Gary Dahl, MD [email protected] Norman Lacayo, MD [email protected] Bone and Soft Tissue Sarcomas, Allison Pribnow, MD [email protected] Renal Tumors, Liver Tumors, Sheri Spunt, MD, MBA [email protected] Germ Cell Tumors HLH Michael Jeng, MD [email protected] Michael Link, MD [email protected] Hodgkin’s and Non-Hodgkin’s Lymphoma Lianna Marks, MD [email protected] Kara Davis, DO [email protected] Immunotherapy Crystal Mackall, MD [email protected] Liora Schultz, MD [email protected] Neuroblastoma Robbie Majzner, MD [email protected] 725 Welch Rd, Palo Alto, CA 94304 | (650) 497-8953 | basscenter.stanfordchildrens.org 041672| 07/21 Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation 2 Cynthia Campen, MD [email protected] Paul Fisher, MD [email protected] Neuro-Oncology Michelle Monje, MD [email protected] Sonia Partap, MD [email protected] Rajni Agarwal-Hashmi, MD [email protected] Alice Bertaina, MD [email protected] Stem Cell Transplantation Agnieszka Czechowicz, MD, PhD [email protected] Maria Grazia Roncarolo, MD [email protected] Ami Shah, MD [email protected] Oncology: Leukemia/Lymphoma NCT #/Phase Title Sponsor Investigator Contact Phase II/III TOT17: Total Therapy XVII for Newly Diagnosed Patients St. Jude Norman Regina Dagher, NP, (NCT03117751) With Acute Lymphoblastic Leukemia and Lymphoma Lacayo [email protected] Phase II AML16: Phase II Trial of Epigenetic Priming in Patients St. Jude Norman Stefania Chirita, (NCT03164057) with Newly Diagnosed Acute Myeloid Leukemia Lacayo [email protected] Phase I TINI: Total Therapy for Infants with Acute Lymphoblastic St. Jude Norman Stefania Chirita, (NCT02553460) Leukemia (ALL) Lacayo [email protected] Phase II Pediatric Classical Hodgkin Lymphoma Consortium St. Jude Michael Stefania Chirita, (NCT03755804) Study: cHOD17 Link [email protected] Phase I POE 14-01: Study of Carfilzomib in combination with POETIC Norman Sarah Cardone, RN, (NCT02512926) Cyclophosphamide and Etoposide for Children with Lacayo sarahcardone@ Relapsed or Refractory Solid Tumors and Leukemias stanford.edu Phase I/II POE 16-01: A Phase I/II study of Neratinib in Pediatric POETIC Norman Sarah Cardone, RN, (NCT02932280) Patients with Relapse/Refractory Solid Tumors or Lacayo sarahcardone@ Hematologic Malignancies stanford.edu Phase II A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib Incyte/ Jay Shamanth Kuramkote, (NCT02723994) With Chemotherapy in Children With De Novo High-Risk COG Balagtas skuramkote@ CRLF2-Rearranged and/or JAK Pathway–Mutant Acute stanford.edu Lymphoblastic Leukemia Phase II A Phase 2 Study of the MEK inhibitor Trametinib (IND COG Jay Shamanth Kuramkote, (NCT03190915) #119346, NSC# 763093) in Children with Relapsed or Balagtas skuramkote@ Refractory Juvenile Myelomonocytic Leukemia stanford.edu 725 Welch Rd, Palo Alto, CA 94304 | (650) 497-8953 | basscenter.stanfordchildrens.org 041672| 07/21 Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation 3 NCT #/Phase Title Sponsor Investigator Contact Phase II ANHL12P1: A Randomized Phase II Trial of Brentuximab COG Jay Nancy Sweeters, RN, (NCT01979536) Vedotin or Crizotinib in Combination with Chemotherapy Balagtas nancy.sweeters@ for Newly Diagnosed Patients with Anaplastic Large Cell stanford.edu Lymphoma (ALCL) Phase I A Phase 1 Study of Palbociclib (IND#141416), a CDK 4/6 COG Jay Stefania Chirita, (NCT03792256) Inhibitor, in Combination with Chemotherapy in Children Balagtas [email protected] with Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) Phase I/II IDASA: A Phase I/II, Multicenter, Open- Genentech Norman Sarah Cardone, RN, Label, Multi-Arm Study Evaluating the Safety, Lacayo sarahcardone@ Tolerability, Pharmacokinetics, and Preliminary stanford.edu Activity of Idasanutlin In Combination with Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients with Relapsed/ Refractory Acute Leukemias or Solid Tumors Oncology: Immunotherapy NCT #/Phase Title Sponsor Investigator Contact Phase I Phase I Clinical Trial of Autologous GD2 Chimeric Stanford Crystal Christina Baggott, PhD, (NCT04196413) Antigen Receptor (CAR) T cells (GD2CART) for Mackall [email protected] Diffuse Intrinsic Pontine Gliomas (DIPG) and and Spinal Diffuse Midline Glioma (DMG) Michelle Monje Phase IB Phase IB Clinical Trial of Autologous CD22 Chimeric Stanford Liora Christina Baggott, PhD, (NCT03448393) Antigen Receptor (CAR) T Cells in Children and Young Schultz [email protected] Adults With Recurrent or Refractory B Cell Malignancies (GENE TRANSFER) Phase I Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Stanford Crystal Christina Baggott, PhD, (NCT03241940) Antigen Receptor (CAR) T Cells in Children and Young Mackall [email protected] Adults with Recurrent or Refractory B Cell Malignancies Phase II AALL1721/CASSIOPEIA: A phase II trial of Novartis/ Kara Davis Christina Baggott, PhD, (NCT03876769) tisagenlecleucel in first-line high-risk (HR) pediatric and COG [email protected] young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapy Phase I CCT5027: A Phase 1 Study Evaluating the Safety, Janssen Lori Christina Baggott, PhD, (NCT03904069, Tolerability, and Efficacy of FLT3 Chimeric Antigen Muffly, [email protected] coming soon) Receptor T-cell (CAR-T) AMG 553 in Subjects With Liora Relapsed/Refractory Acute Myeloid Leukemia Schultz 725 Welch Rd, Palo Alto, CA 94304 | (650) 497-8953 | basscenter.stanfordchildrens.org 041672| 07/21 Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation 4 NCT #/Phase Title Sponsor Investigator Contact Phase II An Open-label, Multicenter, Phase 2 Study Evaluating Janssen Liora Christina Baggott, PhD, (NCT03384654) the Efficacy and Safety of Daratumumab in Pediatric Schultz [email protected] and Young Adult Subjects ≥1 and ≤30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Oncology: Neuro-Oncology NCT #/Phase Title Sponsor Investigator Contact Phase II/III SJATRT: Phase 2 Study Of Alisertib as a Single Agent St. Jude Sonia Stefania Chirita, (NCT02114229) in Recurrent or Progressive Central Nervous System Partap [email protected] (CNS) Aypicial Teratoid Rhabdoid Tumors (AT/RTs) and Extra-CNS Malignant Rhabdoid Tumors (MRTs) and in Combination Therapy in Newly Diagnosed AT/RT Phase II/III SJMB12: A Clinical and Molecular Risk-Directed Therapy St. Jude Sonia Stefania Chirita, (NCT01878617) for Newly Diagnosed Medulloblastoma Partap [email protected] Phase II A Phase 2 Study of Reduced Therapy for Newly Diagnosed COG Jay Tiffany Tang, (NCT02724579) Average-Risk WNT-Driven Medulloblastoma (ACNS1422) Balagtas tiffanytang@ stanford.edu Phase II ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral COG Jay Erica Velasco, (NCT02867592) Small-Molecule Inhibitor of Multiple Kinases, in Children Balagtas [email protected] and Young Adults with Refractory Sarcomas, Wilms Tumor and Other Rare Tumors Phase II ACNS1721: A Phase 2 Study of Veliparib (ABT-888, IND # COG Jay Stefania Chirita, (NCT03581292) 139199) and Local Irradiation, Followed by Maintenance Balagtas [email protected] Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E Mutations COG Phase I/II Phase I/II trial of Dabrafenib, Trametinib, and PBTC Sonia Tiffany Tang, (NCT04201457) Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Partap tiffanytang@ Trametinib and HCQ for BRAF fusion/duplication positive stanford.edu or NF1-associated recurrent or progressive gliomas in children and young adults Phase I PBTC-56: A phase I study of the ADAM-10 inhibitor PBTC Michelle Erica Velasco, (NCT04295759) INCB7839 in children with recurrent/progressive high- Monje [email protected] grade gliomas to target microenvironmental neuroligin-3 725 Welch Rd, Palo Alto, CA 94304 | (650) 497-8953 | basscenter.stanfordchildrens.org 041672| 07/21 Phase I and Phase II Clinical Trials: Hematology, Oncology, and Stem Cell Transplantation 5 NCT #/Phase Title Sponsor Investigator Contact Phase I PBTC-051: Phase I Study to Evaluate the Safety and PBTC Michelle Stefania Chirita, (NCT03389802) Tolerability of the CD40 Agonistic Monoclonal Antibody Monje [email protected] APX005M in Pediatric Subjects With Recurrent/ Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma Phase I PBTC-49: A Phase I study of Savolitinib in Recurrent, PBTC Michelle Erica Velasco, (NCT03598244) Progressive or Refractory Medulloblastoma, High-Grade Monje [email protected] Glioma, or Diffuse Intrinsic Pontine Glioma Feasibility Study PBTC-48: Feasibility trial of Optune for children with PBTC Michelle Stefania Chirita, (NCT03033992) recurrent or progressive supratentorial high-grade glioma Monje [email protected] and ependymoma Phase I/II PBTC-047: Phase 1 Trial of Panobinostat
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