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Research

Hematology/Oncology

The Hematology/Oncology Section is very active in Children's Oncology Group and National Cancer Institute research. Hemophilia research focuses on cutting edge drug treatment options and databases to improve the medical care for patients diagnosed with blood disorders. Hematology/Oncology has four dedicated study coordinators to support research within the section. If you want to learn more about any of these studies or you are interested in enrolling your child in a study listed below please contact 252-744-5404 for Oncology studies and 252-744-4773 for Hematology studies.

Open Clinical Trials in Oncology

AALL05B1: A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens
A nationwide (Children's Oncology Group) study for collection and banking of leukemia cells and host germline DNA specimens from children, adolescents and young adults with ALL at first and subsequent marrow relapse for future research to increase the understanding of the mechanisms of relapse and the biology of relapsed ALL.

AALL08B1: Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
A Children's Oncology Group (COG) study for ALL to further refine risk-stratification algorithms to intensify therapy for patients identified to be at high risk of relapse, while sparing toxicity for those highly likely to be cured. This classification study will also be used for participation in companion biology research studies that are not used for treatment allocation, and for voluntary banking of leukemia cells for future research.

AALL0932: Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy)
A Children's Oncology Group (COG) partially randomized phase III trial study of different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized).

AALL1131: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
A National Cancer Institute randomized phase III study of combination chemotherapy in young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations

AALL1231: Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
A National Cancer Institute randomized phase III trial comparing how well combination chemotherapy works when given with or without bortezomib in treating patients with newly diagnosed T-cell acute lymphoblastic leukemia or stage II-IV T-cell lymphoblastic lymphoma.

AAML1531: Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
A Children's Oncology Group (COG) phase III trial study of response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome.

ACCRN07: Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
The Children's Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN's goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer.

AHEP0731: Treatment of Children With All Stages of Hepatoblastoma With Temsirolimus Added to High Risk Stratum Treatment
A National Cancer Institute phase III trial studying the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer.

AHOD1331: A Randomized Phase III Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents
A National Cancer Institute randomized phase III trial studying brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating younger patients with newly diagnosed Hodgkin lymphoma.

ALTE05N1: Umbrella Long-Term Follow-Up Protocol
A clinical trial to keep track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study to allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

ALTE11C1: Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas
A Children's Oncology Group (COG) clinical trial studying blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas.

ANBL00B1: Neuroblastoma Biology Studies
A Children's Oncology Group (COG) trial studying biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma.

ANBL1232: Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma
A Children's Oncology Group (COG) phase III trial studying how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma.

APEC14B1: The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
A Children's Oncology Group (COG) research trial studying the Project: Every Child for younger patients with cancer to help doctors find better methods of treatment and on-going care.

AREN03B2: Renal Tumors Classification, Biology, and Banking Study
A Children's Oncology Group (COG) research trial studying kidney tumors in younger patients by collecting and storing samples of tumor tissue, blood, and urine to help learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

ARST1321: Pazopanib Neoadjuvant Trial in Non-rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib
A National Cancer Institute randomized phase II/III trial studying how well pazopanib hydrochloride, combination chemotherapy, and radiation therapy work and compares it to radiation therapy alone or in combination with pazopanib hydrochloride or combination chemotherapy in treating patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can be removed by surgery.

D9902: Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
A Children's Oncology Group (COG) study collecting and storing tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory.

Open Clinical Trials in Hematology

OMEG-411-02: Dose-Finding Study of SC411 in Children With Sickle Cell Disease
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study of SC411 in children with sickle cell disease (SCD). The primary objective of the study is to evaluate the safety and tolerability of three different doses of SC411 compared to a placebo.

TAURUS: A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog alfa) for Routine Prophylaxis
A phase 4, multi-centered study of weekly prophylaxis dosing of Kovaltry to determine the safety and efficacy of the drug in patients with Hemophilia A.

Using Rivipansel versus Placebo to Treat Pain Crisis in Hospitalized Sickle Cell Disease Patients
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of rivipansel (GMI-1070), in the treatment of vaso-occlusive crisis in hospitalized subjects with Sickle Cell Disease.

Using Rivipansel (GMI-1070) to Treat One or More Pain Crises in Hospitalized Sickle Cell Disease Patients
An open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double-blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.

Using ALO-02 to Treat Children Experiencing Moderate-to-Severe Pain
This study is designed to test the safety of a new formulation (ALO-02) of a drug that is already on the market (oxycodone hydrochloride) in children 7-17 years old with moderate-severe pain. This formulation is designed to release slowly over a period of time and prevent or deter opioid abuse.

Using Embeda to Treat Children Experiencing Moderate-to-Severe Pain
This study is designed to test the safety of a new formulation (Embeda) of a drug that is already on the market (morphine sulfate) in children 7-17 years old with moderate-severe pain. This formulation is designed to release slowly over a period of time and prevent or deter opioid abuse.

ATHNdataset
The purpose of the ATHNdataset is to collect health information on the bleeding and clotting disorders population in other to create a dataset for future research.

My Life, Our Future
My Life, Our Future is a nationwide, pioneering program created to help solve the mysteries of hemophilia. It is designed to help uncover genetic information that can be used by physicians to individualize care, as well as to provide data that may lead to new scientific discoveries and breakthrough treatments.

Community Counts: CDC Public Health Surveillance Project For Bleeding Disorders
The Community Counts project is gathering data to learn more about patients with bleeding and clotting disorders at hemophilia treatment centers (HTCs) nationwide. The goal is to increase knowledge of inhibitors and other complications, reduce and prevent them from happening, and ultimately improve the quality of life of people with bleeding disorders.

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
An event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

BAY81-8973/Bayer 13400 Pediatric Safety and Efficacy Trial
A multi-center Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.

Selected Publications

Wood JC, Cohen AR, Pressel SL, Aygun B, Imran H, Luchtman-Jones L, Thompson AA, Fuh B, Schultz WH, Davis BR, Ware RE. Organ iron accumulation in chronically transfused children with sickle cell anemia: baseline results from the TWiTCH trial. British journal of haematology. 2016; 172(1):122-30.

Ware RE, Davis BR, Schultz WH, Brown RC, Aygun B, Sarnaik S, Odame I, Fuh B, George A, Owen W, Luchtman-Jones L, Rogers ZR, Hilliard L, Gauger C, Piccone C, Lee MT, Kwiatkowski JL, Jackson S, Miller ST, Roberts C, Heeney MM, Kalfa TA, Nelson S, Imran H, Nottage K, Alvarez O, Rhodes M, Thompson AA, Rothman JA, Helton KJ, Roberts D, Coleman J, Bonner MJ, Kutlar A, Patel N, Wood J, Piller L, Wei P, Luden J, Mortier NA, Stuber SE, Luban NL, Cohen AR, Pressel S, Adams RJ; Hydroxycarbamide versus chronic transfusion for maintenance of transcranial doppler flow velocities in children with sickle cell anaemia-TCD With Transfusions Changing to Hydroxyurea (TWiTCH): a multicentre, open-label, phase 3, non-inferiority trial. Lancet (London, England). 2016; 387(10019):661-70.

Alston KJ, Valrie CR, Walcott C, Warner TD, Fuh B. Experiences of Pediatric Patients with sickle cell diseases in Rural emergency departments. Journal of pediatric hematology/oncology. 2015; 37(3):195-9.

Beverung LM, Strouse JJ, Hulbert ML, Neville K, Liem RI, Inusa B, Fuh B, King A, Meier ER, Casella J, DeBaun MR, Panepinto JA. Health-related quality of life in children with sickle cell anemia: impact of blood transfusion therapy. American journal of hematology. 2015; 90(2):139-43.

Rice H, Englum B, Rothman J, Leonard S, Reiter A, Thornburg C, Brindle M, Wright N, Heeney M, Smithers C, Brown R, Kalfa T, Langer J, Dad M, Oldham K, Scott J, St Peter S, Sharma M, Davidoff A, Nottage K, Bernabe K, Wilson D, Dutta S, Glader B, Crary S, Dassinger M, Dunbar L, Islam S, Kumar M, Rescorla F, Bruch S, Campbell A, Austin M, Sidonio R, Blakely M, The Splenectomy in Congenital Hemolytic Anemia (SICHA) Consortium. Clinical Outcomes of Splenectomy in Children: Report of the Splenectomy in Congenital Hemolytic Anemia (SICHA) Registry. Am J Hematol. 2015; 90 (3): 187-92.

Whitfield, A., Bergmann, S., Lazarchick, J. "Iron Deficiency Anemia Diagnosed in Female Teenagers". Journal of Family Medicine and Community Health. Accepted for publication (2015).

DeBaun MR, Gordon M, McKinstry RC, Noetzel MJ, White DA, Sarnaik SA, Meier ER, Howard TH, Majumdar S, Inusa BP, Telfer PT, Kirby-Allen M, McCavit TL, Kamdem A, Airewele G, Woods GM, Berman B, Panepinto JA, Fuh BR, Kwiatkowski JL, King AA, Fixler JM, Rhodes MM, Thompson AA, Heiny ME, Redding-Lallinger RC, Kirkham FJ, Dixon N, Gonzalez CE, Kalinyak KA, Quinn CT, Strouse JJ, Miller JP, Lehmann H, Kraut MA, Ball WS Jr, Hirtz D, Casella JF. Controlled trial of transfusions for silent cerebral infarcts in sickle cell anemia. The New England Journal of Medicine. 2014; 371(8):699-710

Jeng MR, Fuh B, Blatt J, Gupta A, Merrow AC, Hammill A, Adams D. Malignant transformation of infantile hemangioma to angiosarcoma: response to chemotherapy with bevacizumab. Pediatric blood & cancer. 2014; 61(11):2115-7.

Debaun MR, Sarnaik, Rodighier MJ, Minniti CP, Howard, TH, Iyer RV, Inusa B, Telfer PT, Kirby-Allen M, Quinn CT, Bernaudin F, Airewele G, Woods GM, Panepinto JA, Fuh B, Kwiatkowski JK, King AA, Rhodes MM, Thompson AA, Heiny ME, Redding-Lallinger RC, Kirkham FJ, Sabio H, Gonzalez CE, Saccente SL, Kalinyak KA, Strousse JJ, Fixler JM, Gordon MO, Miller JP, Ichrd RN, Casella JF. Associated risk factors for silent cerebral infarcts in sickle cell anemia: low baseline hemoglobin, gender and relative high systolic blood pressure: Blood. 2012; 119(16);3684-90.

Page C, Reid A, Hoagland E, Leonard SB. WellBabies: mothers’ perspectives on an innovative model of group well-child care. Family Medicine. 2010; 42(3): 202-207.

Jordan LC, Mckinstry RC, Kraut MA, Ball WS, Vendt BA, Casella JF, Debaun MR, Strousse JJ; For Silent Infarct transfusions Trial Investigators (Fuh, B included): Incidental Findings on brain magnetic resonance imaging of children with sickle cell disease: Pediatrics. 2010; 126(1); 53-61.

Beng Fuh, Joseph Lurito, Mauro Grossi, Charles Daeschner, Suzanne Russo: Bilateral internal carotid artery occlusions in a pediatric patient with refractory acute myeloid leukemia. Pediatr Blood cancer. 2010; 54(5): 657–783.

Beng Fuh, Ronald Perkin: Sickle Cell Disease Emergencies in Children: Pediatric Emergency Medicine Reports: December 2009

Hutzen B, William W, Jones S, Cen L, DeAngelis S, Fuh B, Lin J: Dietary agent, benzyl isothiocyanate inhibits Signal Transducers and Activators of Transcription 3 phosphorylation and collaborates with sulforaphane in the growth suppression of PANC-1 cancer cells. Cancer cell International 2009; (24).

Fuh B, Sobo M et al: LLL-3 inhibits STAT3 activity, suppresses glioblastoma cell growth and prolongs survival in a mouse glioblastoma model. Br J Cancer. 2009; 100 (1): 106-12.

Fuh BR, Ronald Perkin: Clinical Presentation, Evaluation and Management of Bleeding Disorders in Children. Pediatric Emergency Medicine Reports. 2009: 14 (3).

Kerlin B, Blatt N, Fuh B et al: Epidemiology and Risk Factors for Thromboembolic Complications of Children with Nephrotic Syndrome. The Journal of Pediatrics. 2009.

Stitzenberg KB, Thomas NE, Dalton K, Brier SE, Ollila DW, Berwick M, Mattingly D, Millikan RC. Distance to Diagnosing Provider as a Measure of Access for Patients With Melanoma. Archives of Dermatology. 2007; 143(8): 991-998.

Caudle AS, Brier SE, Calvo BF, Kim HJ, Meyers MO, Ollila DW. Experienced radio-guided surgery teams can successfully perform minimally invasive radio-guided parathyroidectomy without intraoperative parathyroid hormone assays. The American Surgeon. 2006; 72(9):785-789.

Stitzenberg KB, Brier SE, Ollila DW, Millikan RC, Mattingly DM, Thomas, NE. Analysis of relationship between distance to diagnosing provider and Breslow depth at diagnosis. Journal of Clinical Oncology, ASCO Annual Meeting Proceedings. 2005; 23(16S):6018.

Hooks WB, Brier SE, Monia MP, Johnston J, Weston BW. Inhibition of Hepatocellular Carcinoma Proliferation with FUT6 Antisense Oligonucleotides. Journal of Pediatric Hematology/Oncology. 2001; 23(3):A21.