Submitted by klmcguire on Thu, 02/27/2020 - 10:21

Carilion Pediatrics provides specialty care for issues like heart problems and asthma so you don't need to travel long distances to see a top-notch doctor. We're proud to have assembled a highly trained and experienced team of pediatric specialists who provide expert care for children right here in our community. We welcome participation by interested individuals in our pediatric research.

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Newly Diagnosed High-Risk B-Lymphoblastic Leukemia

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

PROTOCOL ID COG # AAML1732

PROTOCOL DESCRIPTION This study is for newly diagnosed patients with newly diagnosed high-risk B-lymphoblastic leukemia.

ELIGIBILITY CRITERIA

  • Patient has newly diagnosed B-ALL or MPAL with > 25% blasts on a BM aspirate
  • Patient has newly diagnosed B-LLy Murphy stages III or IV
  • Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment
  • Patients must be > 365 days and < 25 years of age

EXCLUSION CRITERIA

  • Patients with Down syndrome
  • Patients that are pregnant
  • Patients with acute undifferentiated leukemia

Primary Investigator Glen Edwards, M.D.

Contact Information Wendy McCarty Clinical Research Coordinator II Office: 540-266-6238 wpmccarty@carilionclinic.org

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Pediatric Oncology
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Newly Diagnosed B-Lymphoblastic Leukemia/Lymphoma 

PROTOCOL ID COG # AALL 1731

PROTOCOL DESCRIPTION A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy).

ELIGIBILITY CRITERIA

  • Patient has newly diagnosed B-cell ALL, with or without Down syndrome with > 25% blasts on a BM aspirate
  • Patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without Down syndrome
  • Patients must be > 365 days and < 31 years of age

EXCLUSION CRITERIA

  • ALL development after a previous cancer treated with cytotoxic chemotherapy
  • Patients who have received > 72 hours of hydroxyurea
  • Patients with acute undifferentiated leukemia

Primary Investigator Glen Edwards, M.D.

Contact Information Wendy McCarty Clinical Research Coordinator II Office: 540-266-6238 wpmccarty@carilionclinic.org

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Newly Diagnosed B-Lymphoblastic Leukemia/Lymphoma
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International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL 

PROTOCOL ID COG # AALL1631

PROTOCOL DESCRIPTION International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones.

ELIGIBILITY CRITERIA

  • Age: > 1 year and < 21 years at ALL diagnosis
  • Diagnosis: Newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia
  • Prior Therapy: Patient must have previously started Induction therapy for no more that 14 days, which includes vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or other standard cytotoxic chemotherapy.

EXCLUSION CRITERIA

  • Known history of chronic myelogenous leukemia (CML)
  • ALL developing after a previous cancer treated with cytotoxic chemotherapy
  • Down syndrome
  • Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib

Primary Investigator Glen Edwards, M.D.

Contact Information Wendy McCarty Clinical Research Coordinator II Office: 540-266-6238 wpmccarty@carilionclinic.org

For additional information on Children's Oncology studies, please visit www.childrensoncologygroup.org.

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Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
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A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin GO To CPX-351 With GO, and the Addition of The FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations

PROTOCOL ID
COG # AAML1831

PROTOCOL DESCRIPTION

The overall goal of this study is to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, and to find out what effects, good and/or bad, the drug gilteritinib has when given with chemotherapy to children and young adults with newly diagnosed AML and the FLT3/ITD mutation or non-ITD FLT3 activating mutations.

Inclusion Criteria:

  • Diagnosis:
    • Patient must be newly diagnosed with de novo AML according to the 2016 WHO classification with or without extramedullary disease.
  • Age: 
    • Less than 22 years of age at diagnosis
  • Eligibility Screening:
    • All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831.

Exclusion Criteria: 

Patients with the following constitutional conditions are not eligible.

  • Patients with myeloid neoplasms with germline predisposition are not eligible.
  • Fanconi anemia
  • Shwachman Diamond syndrome
  • Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
  • Any other known bone marrow failure syndrome

Patients with any of the following oncologic diagnoses are not eligible.

  • Any concurrent malignancy
  • Juvenile myelomonocytic leukemia (JMML)
  • Philadelphia chromosome positive AML
  • Mixed phenotype acute leukemia
  • Acute promyelocytic leukemia
  • Acute myeloid leukemia arising from myelodysplasia
  • Therapy-related myeloid neoplasms

Prior Therapy

Administration of prior anti-cancer therapy except as outlined below:

  • Hydroxyurea
  • All-trans retinoic acid (ATRA)
  • Corticosteroids (any route)
  • Intrathecal therapy given at

 

Primary Investigator(s): 
Glenn Edwards, M.D.

Contact Information:
Wendy McCarty
Clinical Research Coordinator II
Office: 540-266-6238
wpmccarty@carilionclinic.org

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Comparing Standard Therapies: COG# AAML1831
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A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients  

PROTOCOL ID

COG # ACNS1422

PROTOCOL DESCRIPTION

The overall goal of this study is to find out if a reduced dose of radiation to the whole brain and spine and less chemotherapy can be given to children and young adults with WNT subtype medulloblastoma without increasing the risk of the tumor coming back. The combination of a reduction in radiation therapy and chemotherapy is experimental.

Inclusion Criteria:

  • Diagnosis:
    • Patient is suspected to have newly-diagnosed average-risk medulloblastoma by institutional diagnosis.
  • Age:
    • Patients must be greater than or equal to 3 years and less than 22 years of age
  • Eligibility Screening:
    • All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment

Exclusion Criteria:

  • Metastatic disease
  • Prior Therapy
    • Radiation Therapy
    • Chemotherapy

Primary Investigator(s):
Glenn Edwards, M.D.

Contact Information:
Wendy McCarty
Clinical Research Coordinator II
Office: 540-266-6238
wpmccarty@carilionclinic.org

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Medulloblastoma Study: COG # ACNS1422
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EveryChild A Registry, Eligibility Screening, Biology and Outcome Study

PROTOCOL ID

COG# APEC14B1

PROTOCOL DESCRIPTION

This protocol provides for the collection of biospecimens and accompanying demographic, epidemiologic, therapeutic, and outcome data from all children diagnosed with cancer at participating COG institutions, independent of the patient’s enrollment on a therapeutic clinical trial.

Inclusion Criteria:

  • Diagnosis:
    • Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent, or young adult populations are eligible for enrollment as follows:
    • All cancer cases with an ICD-O histologic behavior code of two “2” (carcinoma in situ) or three “3” (malignant).
    • All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline, or malignant.
    • The following other benign/borderline conditions:
      • Mesoblastic nephroma
      • Teratomas (mature and immature types)
      • Myeloproliferative diseases including transient myeloproliferative disease
      • Langerhans cell histiocytosis
      • Lymphoproliferative diseases
      • Desmoid tumors
      • Gonadal stromal cell tumors
  • Age:
    • Subjects must be ≤ 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating NCTN) therapeutic study, for which there is a higher upper age limit.
  • Timing:
    • Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem.

Exclusion Criteria: 

  • Not meeting the Inclusion Criteria

Primary Investigator(s): 
Glenn Edwards, M.D.

Contact Information
Wendy McCarty
Clinical Research Coordinator II
Office: 540-266-6238
wpmccarty@carilionclinic.org

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EveryChild Study: COG# APEC14B1
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There are currently no active Pediatric Pulmonology research studies.

Contact Information Kellie Hirt, M.S. Clinical Research Coordinator Phone: 540-985-9934 kehirt@carilionclinic.org

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Pediatric Pulmonology
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