Cancer and Blood Disorders CCBD

NCT04546399 (Active) / Tamra Slone, MD

• AALL1821, A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 147294) in Combination with Nivolumab (NSC # 748726, IND# 147294), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged ≥ 1 to < 31 Years Old with First Relapse

NCT04726241 (Active) / Kathleen Ludwig, MD

• APAL2020SC, Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias

NCT05183035 (Active) / Kathleen Ludwig, MD

• APAL2020D, A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML

NCT03394365 (Active) / Tamra Slone, MD

• ATA129-EBV-302, ALLELE Study, Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy

NCT03601442 (Active) / Samuel John, MD

• CCTL019B2003I, Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

NCT05761171 (Active) / Caroline Smith, MD

• AALL2121, A Phase 2 study of SNDX-5613 in combination with chemotherapy for patients with relapsed or refractory KMT2A-rearranged infant leukemia

NCT06177067 (Active) / Kathleen Ludwig, MD

• RAVAML: A PHASE I STUDY OF REVUMENIB, AZACITIDINE, AND VENETOCLAX IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH REFRACTORY OR RELAPSED ACUTE MYELOID LEUKEMIA

NCT05849662 (Pending) / Tamra Slone, MD

• T2020-004, Risk stratified treatment for patients with newly diagnosed juvenile myelomonocytic leukemia: A Phase I/II non-randomized study of trametinib and azacitidine with or without chemotherapy (IND # 164058)

NCT02332668 (Active) / Tanya Watt, MD

• ADVL1621, MK-3475-051, A Phase I/II Study of Pembrolizumab (MK-3475) in Children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma (KEYNOTE-051)

NCT06064097 (Active) /Avanthi Shah, MD

• ARAR2221, Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)

NCT03394365 (Active) / Tamra Slone, MD

• ATA129-EBV-302, ALLELE Study, Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy

NCT05286801 (Active) / Laura Klesse, MD

• PEPN2121, A Phase 1/2 Study of Tiragolumab (NSC# 827799, IND# 161266) and Atezolizumab (NSC# 783608, IND# 161266) in Patients with Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

NCT02013336 (Active) / Patrick Leavey, MD

• SPOC-2012-001, Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors

NCT04094610 (Active) / Tanya Watt, MD

• TPX-0005-07, A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, & Anti-Tumor Activity Study of Repotrectinib in Pediatric & Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations

NCT04796012 (Active) / Arhanti Sadanand, MD

• VITAS, Atezolizumab in combination with chemotherapy for pediatric relapsed/refractory solid tumors: An open-label, phase I/II, single-arm, multi-center trial

NCT05734066 (Active) / Avanthi Shah, MD

• JZP712-101-00, A phase 1/2, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and efficacy of lurbinectedin monotherapy in pediatric participants with previously treated solid tumors followed by expansion to assess efficacy and safety in pediatric and young adult participants with relapsed/refractory Ewing sarcoma

NCT04870944 (Active) / Laura Klesse, MD

• PEPN2111, Phase 1/2 study of CBL0137 in patients with relapsed or refractory solid tumors including CNS and Lymphoma

NCT06465199 (Pending) / Tanya Watt, MD

• BCC020, A Dose Escalation Study Using Difluoromethylornithine (DFMO) and AMXT-1501 followed by a randomized controlled trial of DFMO with or without AMXT-1501 for neuroblastoma, CNS tumors, and sarcomas

NCT06541262 (Pending) / Tanya Watt, MD

• BCC021, Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors

NCT06735820 (Pending) / Laura Klesse, MD

• MEKMDM2: Early Phase Study to Evaluate the MEK Inhibitor Selumetinib with the MDM2 Inhibitor APG-115 in Patients with Neurofibromatosis Type 1 and Pre-malignant and Malignant Peripheral Nerve Sheath Tumors

NCT05099003 (Active) / Laura Klesse, MD

• ACNS1821, A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

NCT04870944 (Active) / Laura Klesse, MD

• PEPN2111, Phase 1/2 study of CBL0137 in patients with relapsed or refractory solid tumors including CNS and Lymphoma

NCT05610891 (Active) / Avanthi Shah, MD

• DCL-17-001, An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children, Adolescents, and Young Adults with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors (CLOVER-2) and Expansion in Children, Adolescents and Young Adults with Relapsed or Refractory High-Grade Glioma

NCT06413706 (Active) / Avanthi Shah, MD

• I3Y-MC-JPEH, A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy

NCT04485559 (Pending) / Laura Klesse, MD

• PNOC021, A Phase I Trial Evaluating the Combination of Trametinib and Everolimus in Pediatric and Young Adult Patients with Recurrent Low Grade Gliomas and High Grade Gliomas

NCT06465199 (Pending) / Tanya Watt, MD

• BCC020, A Dose Escalation Study Using Difluoromethylornithine (DFMO) and AMXT-1501 followed by a randomized controlled trial of DFMO with or without AMXT-1501 for neuroblastoma, CNS tumors, and sarcomas

NCT06541262 (Pending) / Tanya Watt, MD

• BCC021, Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors

NCT06701812 (Pending) / Avanthi Shah, MD

• MCC23221 Evaluation of Digoxin for Relapsed non-WNT, non-SHH Medulloblastoma

NCT04301843 (Active) / Tanya Watt, MD

• BCC015, Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

NCT02679144 (Active) / Tanya Watt, MD

• NMTRC014, NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

NCT02013336 (Active) / Patrick Leavey, MD

• SPOC-2012-001, Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors

NCT06450041 (Pending) / Tanya Watt, MD

• NANT 2021-01, PHASE II STUDY OF EX-VIVO EXPANDED ALLOGENEIC UNIVERSAL DONOR TGFβi NK CELL INFUSIONS IN COMBINATION WITH TEMOZOLOMIDE, IRINOTECAN, DINUTUXIMAB, AND SARGRAMOSTIM IN PATIENTS WITH RELAPSED OR REFRACTORY NEUROBLASTOMA The STING (Sequential Temozolomide, Irinotecan, NK cells and GD2 mAb) Trial

NCT06465199 (Pending) / Tanya Watt, MD

• BCC020, A Dose Escalation Study Using Difluoromethylornithine (DFMO) and AMXT-1501 followed by a randomized controlled trial of DFMO with or without AMXT-1501 for neuroblastoma, CNS tumors, and sarcomas

NCT06541262 (Pending) / Tanya Watt, MD

• BCC021, Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors

NCT04616560 (Active) / Laura Klesse, MD

• PEPN1924, A Phase 2 Study of DS-8201a (NSC# 807708, IND#153036) in Adolescents, or Young Adults with Recurrent HER2+ Osteosarcoma

NCT02013336 (Active) / Patrick Leavey, MD

• SPOC-2012-001, Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors

NCT04796012 (Active) / Arhanti Sadanand, MD

• VITAS, Atezolizumab in combination with chemotherapy for pediatric relapsed/refractory solid tumors: An open-label, phase I/II, single-arm, multi-center trial

NCT05734066 (Active) / Avanthi Shah, MD

• JZP712-101-00, A phase 1/2, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), recommended phase 2 dose (RP2D), and efficacy of lurbinectedin monotherapy in pediatric participants with previously treated solid tumors followed by expansion to assess efficacy and safety in pediatric and young adult participants with relapsed/refractory Ewing sarcoma

NCT05634369 (Active) / Avanthi Shah, MD

• MCC21704, The TiNKS Trial: A Multi-Institution Study of TGFB imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination with Gemcitabine and Docetaxel in Patients with Relapsed or Refractory Pediatric Bone and Soft Tissue Sarcomas

NCT06465199 (Pending) / Tanya Watt, MD

• BCC020, A Dose Escalation Study Using Difluoromethylornithine (DFMO) and AMXT-1501 followed by a randomized controlled trial of DFMO with or without AMXT-1501 for neuroblastoma, CNS tumors, and sarcomas

NCT06541262 (Pending) / Tanya Watt, MD

• BCC021, Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors

NCT03394365 (Active) / Tamra Slone, MD

• ATA129-EBV-302, ALLELE Study, Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy

NCT03601442 (Active) / Samuel John, MD

• CCTL019B2003I, Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release

NCT05634369 (Active) / Matthew Campbell, MD

• MCC21704, The TiNKS Trial: A Multi-Institution Study of TGFB imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination with Gemcitabine and Docetaxel in Patients with Relapsed or Refractory Pediatric Bone and Soft Tissue Sarcomas

NCT06154252 (Pending) Samuel John, MD

• CAB-201-002, Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Idiopathic Inflammatory Myopathy or Active Juvenile Idiopathic Inflammatory Myopathy