Division of Pediatric Hematology-Oncology

About Our Program

Program Mission

We are active members of the following consortiums offering clinical trials to patients with high-risk, relapsed and refractory malignancies: The mission of the Developmental Therapeutics and Pharmacology program is two-fold.

First, we seek to provide novel, safe, effective therapeutic options to children with high-risk, relapsed, and refractory malignancies. We are carrying out clinical, genomic, and biological research that will enhance care for future generations of children. We are utilizing a combination of UNC investigator-initiated, cooperative group, and pharmaceutical led trials to offer a range of options when precision medicine approaches are indicated, or when standard therapies have failed.

Second, we are utilizing the strengths of the UNC School of Pharmacy and the Lineberger Cancer Center to investigate dosing and toxicity of traditional agents, pharmacology of new molecules, and novel drug delivery mechanisms.

NANT

Program Leaders

Click here to email Drs. Alexander and Thompson to discuss trial eligibility or call 919-966-1178

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Developmental Clinical Trials – Currently Open

Diagnosis Sponsor Study Title with ClinicalTrails.Gov Link
Acute Myeloid Leukemia

Relapsed or Refractory

St. Jude A Phase I And Expansion Cohort Study Of Venetoclax In Combination With Chemotherapy In Pediatric Patients With Refractory Or Relapsed Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia

Ph-Like with JAK Pathway Alteration

COG/Incyte A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia

Relapsed or Refractory

COG AALL1331: Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND# 117467, NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
Acute Lymphoblastic Leukemia

Relapsed or Refractory

COG AALL1621: A 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)
Acute Lymphoblastic Leukemia

Relapsed or Refractory

AbbVie A Phase 1 Dose Escalation, Open-Label Study of Venetoclax in Combination with Navitoclax and Chemotherapy in Subjects with Relapsed Acute Lymphoblastic Leukemia
Hodgkin Lymphoma

Relapsed or Refractory

UNC Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Prevention of Relapse of CD30+ Lymphomas after High Dose Therapy and Autologous Stem Transplantation (ATLAS)
Hodgkin Lymphoma

Relapsed or Refractory

UNC Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor for Relapsed CD30+ Hodgkin’s Lymphoma and CD30+ Non-Hodgkin’s Lymphoma (CART CD30)
Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders

Relapsed or Refractory

COG Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients with Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders
Neuroblastoma

Relapsed or Refractory

COG ANBL1531: A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND# 61010) or Chimeric 14.18 Antibody (ch14.18) (NSC# 623408, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma
Solid Tumors

Relapsed or Refractory

COG ADVL1622: Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors
Solid Tumors

Relapsed or Refractory

COG/GSK A Phase II Study of Pazopanib (GW786034, NSC# 737754) in Children, Adolescents and Young Adults with Refractory Solid Tumors
Sarcoma

Relapsed or Refractory

SUNSHINE Phase II Study of nab-Paclitaxel in Combination with Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults
Solid Tumors

Relapsed or Refractory with NTRK fusions

Loxo Oncology A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 in Subjects with NTRK Fusion-Positive Tumors
Neuroblastoma

Relapsed or Refractory

NANT NANT17-01: A Phase I Study of 131I-MIBG with Dinutuximab for Relapsed/Refractory Neuroblastoma
Neuroblastoma

Relapsed or Refractory

NANT NANT13-01: Phase I dose escalation study of autologous expanded Natural Killer (NK) cells for immunotherapy of relapsed refractory neurblastoma with dinutuximab +/- lenalidomide
Neuroblastoma

Relapsed or Refractory

Jubilant Expanded Access: An open-label, expanded access protocol using 131i-metaiodobenzylguanidine (131I-MIBG) therapy in patients with refractory neuroblastoma, pheochromocytoma, or paraganglioma
Neuroblastoma

Relapsed or Refractory

NANT NANT15-01: Neuroblastoma Precision Trial

 
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Developmental Clinical Trials – In Process of Opening

Diagnosis Sponsor Study Title
Acute Lymphoblastic Leukemia

Relapsed or Refractory

UNC Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia
Neuroblastoma

Relapsed or Refractory

NANT NANT11-01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma
Neuroblastoma

Relapsed or Refractory

NANT NANT15-02: Phase I study of Lorlatinib, an oral small molecule inhibitor of ALK/ROS1, for patients with ALK-driven Relapsed or Refractory Neuroblastoma

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Recent publications; for additional publications from Drs. Thompson or Alexander, please click here.

  1. Opportunities for expanding clinical trial enrollment for relapsed and refractory pediatric acute myeloid leukemia in the United States and Canada. Alexander, T.B., Bhakta, N., Kolb, E.A. & Rubnitz, J.E. (2017). Pediatric Blood & Cancer. 
  2. The genetic basis and cell of origin of mixed phenotype acute leukaemia. Alexander, T.B, et al. (2018). Nature.
  3. Adverse effects of pegaspargase in pediatric patients receiving doses greater than 3,750 IU. Lebovic, R., Pearce, N., Lacey, L., Xenakis, J., Faircloth, C.B., & Thompson, P. (2017). Pediatric Blood & Cancer. 
  4. Vincristine toxicity with co-administration of fluconazole during induction therapy for pediatric acute lymphoblastic leukemia. Smitherman, A.B., Faircloth, C.B., Deal, A., Troy, M., & Gold, S.H. (2017). Pediatric Blood & Cancer. 
  5. Phase I Study of Selinexor, a Selective Inhibitor of Nuclear Export, in Combination With Fludarabine and Cytarabine, in Pediatric Relapsed or Refractory Acute Leukemia. Alexander T.B., Lacayo N.J., Choi J.K., Ribeiro R.C., Pui C.H., Rubnitz J.E.. (2016) J Clin Oncol.

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