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Phase I / II Clinical Trials

 

St. Jude Clinical Trials

FIX-GT: Factor IX Gene Therapy Study for Patients with Hemophilia B

Diseases Treated:

Hemophilia B

Eligibility:

  • Male
  • At least 18 years old
  • Diagnosis of hemophilia B
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FLOPET: PET Scan Studies to Analyze Neuroblastoma and Pheochromocytoma Tumors

Diseases Treated:

Neuroblastoma, pheochromocytoma

Eligibility:

This study is open to St. Jude patients only.

  • Known or suspected neuroblastoma or pheochromocytoma
  • At least 1 year old

 

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HALGG: Hippocampal-Avoidance Using Proton Therapy in Children with Brain Tumors

Diseases Treated:

 Low-grade glioma

Eligibility:

  • At least 6 years old and younger than 22
  • Diagnosis of low-grade glioma
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HAPSAA: Partially Matched Related Donor Bone Marrow Transplant for Patients with Aplastic Anemia

Diseases Treated:

Aplastic Anemia

Eligibility:

  • 21 years old and younger
  • Diagnosis of severe aplastic anemia
  • No available matched donor
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INOMRD: Inotuzumab Ozogamicin for Children with High-Risk B-Cell ALL

Diseases Treated:

Acute lymphoblastic leukemia

Eligibility:

  • Younger than 22 years old
  • Diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) with minimal residual disease (MRD) between 0.1 and 4.99% after prior chemotherapy, relapse or stem cell transplant
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MEMCAR19: Allogeneic CAR T-Cell Therapy for Relapsed/Refractory CD19-Positive Leukemia

Diseases Treated:

Acute lymphoblastic leukemia

Eligibility:

Donor eligibility includes:

  • At least 18 years old
  • At least single haplotype matched family member

Recipient eligibility includes:

  • 21 years old or younger*
  • Diagnosed with relapsed and/or refractory CD19-positive leukemia
  • Not suitable for autologous CD19-CAR T-cell therapy

* Initial 3 participants must be at least 16 years old.

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MEMCRT: Memantine to Prevent Thinking Problems in Children Receiving Radiation for Certain Brain Tumors

Diseases Treated:

Brain Tumors

Eligibility:

  • Between 6 and 21 years old
  • Diagnosis of localized low-grade gliomacraniopharyngioma, ependymoma, meningioma or germ cell tumor 
  • Initiating focal cranial radiation therapy (photon or proton)
  • Able to swallow pills
  • Participant and parent/legal guardian speak, read and understand English
  • Normal ECG and laboratory tests
  • Adequate vision and hearing
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PMVOCVR: Virtual Reality Therapy for Vaso-Occlusive Crisis in Patients with Sickle Cell Disease

Diseases Treated:

Sickle cell disease

Eligibility:

This is a non-therapeutic clinical trial that is open only to patients at St. Jude or Methodist Healthcare.

  • Between 6 and 25 years old
  • Diagnosed with sickle cell disease
  • Seeking care for acute vaso-occlusive crisis pain at St. Jude Children’s Research Hospital or Methodist Healthcare
  • Speaks English
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REF2HCT: Haploidentical Bone Marrow Transplant for Leukemia and Lymphoma

Diseases Treated:

Eligibility:

  • 21 years old and younger
  • Diagnosed with one of the following that has come back or did not improve after bone marrow transplant
    • Acute lymphoblastic leukemia (ALL)
    • Acute myeloid leukemia
    • Myeloid sarcoma
    • Chronic myeloid leukemia (CML)
    • Juvenile myelomonocytic leukemia (JMML)
    • Myelodysplastic syndrome (MDS)
    • Non-Hodgkin lymphoma (NHL)
  • Has a family member who is a suitable stem cell donor
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RT3CR: Proton Therapy for Pediatric Craniopharyngioma

Diseases Treated:

Craniopharyngioma

Eligibility:

  • 21 years old or younger
  • Diagnosis of craniopharyngioma
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SENDAI: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity

Eligibility:

  • Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
  • Child has adequate blood, liver and kidney function.
  • Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.
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SJ901: Study of Mirdametinib as a Treatment for Children, Adolescents and Young Adults with Low-Grade Glioma

Diseases Treated:

Low-Grade Glioma

Eligibility:

At least 2 years old and younger than 25 years old

Diagnosis of progressive or relapsed low-grade glioma 

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SJATRT: Phase II Study of Alisertib Therapy for Rhabdoid Tumors

Diseases Treated:

Brain Tumor : Recurrent, progressive, or newly diagnosed atypical teratoid rhabdoid brain tumors (ATRT)
Solid Tumor : Progressive extra-CNS malignant rhabdoid solid tumors (MRT)

Eligibility:

  • Has one of these types of tumors:
    • Newly diagnosed atypical teratoid rhabdoid tumors (ATRTs) or synchronous extraneural ATRTs
    • ATRTs or malignant rhabdoid tumors (MRTs) that have come back after previous treatment (recurrent disease)
    • ATRTs or MRTs that are growing after previous treatment (progressive disease)
  • 21 years of age or younger
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SJDAWN: Molecular-Based Therapy for Aggressive Brain and Spinal Cord Tumors in Children and Young Adults

Diseases Treated:

Brain tumor, medulloblastoma, ependymoma

Eligibility:

  • 1 to 39 years old
  • Recurrent, progressive or refractory medulloblastoma, ependymoma or central nervous system (CNS) tumor
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SJELIOT: Phase I Study of a CHK1/2 Inhibitor Therapy in Combination with Chemotherapy for Children and Adolescents with Refractory or Recurrent Medulloblastoma Brain Tumors

Diseases Treated:

Medulloblastoma

Eligibility:

Eligibility Overview

  • Recurrent, refractory or progressive medulloblastoma
  • At least 1 year old and younger than 25 years old
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SJMB12: A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma/PNET

Diseases Treated:

Medulloblastoma (includes all variants of medulloblastoma and posterior fossa PNET)

Eligibility:

  • Diagnosis of newly medulloblastoma
  • At least 3 years old and younger than 22 years old (Strata W, S or N) OR
  • At least 22 years old and younger than 40 years old AND has SHH medulloblastoma (Stratum S)
  • Has not received previous treatment with radiation therapy or chemotherapy
  • Must start treatment within 36 days of surgery to remove the tumor
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SJRET6: Combination Chemotherapy in Treating Patients with Newly Diagnosed, Previously Untreated Intraocular Retinoblastoma

Diseases Treated:

Retinoblastoma

Eligibility:

  • Newly diagnosed retinoblastoma that has not spread beyond the eye
  • Has not received previous treatment with chemotherapy or radiation therapy
  • Patients who have been diagnosed with retinoblastoma in one eye who did not receive chemotherapy, but then developed retinoblastoma in the opposite eye
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TINI: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL)

Diseases Treated:

Acute lymphoblastic leukemia (ALL)

Eligibility:

  • Newly diagnosed ALL
  • 1 year of age or younger at the time of diagnosis
  • Has not had any — or has had limited — prior therapy
  • Does not have mature B-cell ALL, acute myeloid leukemia (AML) or Down syndrome
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Collaborative Clinical Trials

ACNS1721: A Study of the Drug Veliparib with Radiation Therapy in Patients with Newly Diagnosed High-Grade Glioma

Diseases Treated:

High-grade glioma

Eligibility:

  • 3 to 25 years old
  • Newly diagnosed high-grade-glioma[SJ1] , such as anaplastic astrocytoma or glioblastoma
  • Negative test for H3 K27M mutation
  • Negative test for BRAFV600 mutation
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ADV1414: Phase I Study of Selinexor to Treat Patients with Recurrent and Refractory Pediatric Solid Tumors

Diseases Treated:

Solid Tumors

Eligibility:

  • Diagnosis of solid tumor that is resistant to other anticancer therapy or has come back after therapy. Includes lymphoma and central nervous system (CNS) tumors that may or may not require surgery.
  • Fully recovered from the acute toxic effects of all prior anticancer therapy
  • At least 1 but not more than 21 years of age
  • Able to swallow tablets whole
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ADVL1823: Larotrectinib (LOXO-101) in Children with TRK Fusion Solid Tumors and Relapsed Leukemia

Diseases Treated:

Solid Tumors 
Leukemias

Eligibility:

  • 21 years old or younger (at St. Jude)
  • Newly diagnosed infantile fibrosarcoma  or solid tumor with NTRK1, NTRK2 or NTRK3 fusion OR
  • Relapsed/refractory acute leukemia with NTRK1, NTRK2 or NTRK3 fusion
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CASPER: A Study to Evaluate the Safety and Efficacy of CRISPR Cas9 Gene Editing in Patients with Severe Sickle Cell Disease

Diseases Treated:

Sickle Cell Disease

Eligibility:

  • 18 to 35 years old (Ages 18 to 25 at St. Jude)
  • Diagnosis of severe sickle cell disease (SCD)
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FIX-GT: Factor IX Gene Therapy Study for Patients with Hemophilia B

Diseases Treated:

Hemophilia B

Eligibility:

  • Male
  • At least 18 years old
  • Diagnosis of hemophilia B
View Trial

HLHRUXO: Ruxolitinib Therapy for HLH

Diseases Treated:

Hemophagocytic Lymphohistiocytosis

Eligibility:

  • 6 weeks to 22 years old
  • Newly diagnosed hemophagocytic lymphohistiocytosis (HLH)
  • Relapsed or refractory HLH
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LOXORET: Phase I/II Study of LOXO-292 (Selpercatinib) in Patients with Advanced RET-Altered Solid Tumors or Brain Tumors

Diseases Treated:

Solid tumors, Brain tumors

Eligibility:

  • 6 months to 21 years old
  • Solid tumor or brain tumor that has progressed or spread
  • Failed standard treatment
  • RET gene alteration
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MEKPEM: A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphomas

Diseases Treated:

Advanced melanoma or PD-L1 positive advanced relapsed or refractory solid tumor or lymphoma or high-grade glioma

Eligibility:

  • Between 6 months and 18 years old with diagnosis of MSI-H solid tumor OR
  • Between 12 years and 18 years old with diagnosis of melanoma OR
  • Between 3 and 18 years old with relapsed or refractory classical Hodgkin lymphoma
  • Negative pregnancy test 72 hours prior to medication administration in participants of child-bearing potential
  • Appropriate liver and kidney functions
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P1093: Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents

Diseases Treated:

Human Immunodeficiency Virus

Eligibility:

  • At least 4 weeks old but younger than 18 years old
  • Confirmed HIV-1 infection
  • Current or past treatment with HIV medications (Children younger than 2 years old may be eligible even if they have not been treated with HIV medications.)
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PBTC47: A Clinical Trial of the Drug, Panobinostat, in Children with Brain Tumors

Diseases Treated:

Diffuse Intrinsic Pontine Glioma (DIPG)

Eligibility:

  • Diagnosis of progressive diffuse intrinsic pontine glioma (DIPG) or an increase in the bi-dimensional measurement or the appearance of a new tumor lesion since diagnosis
  • At least 2 but not more than 22 years old
  • Able to swallow capsules whole
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PBTC49: Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, HGG or DIPG

Diseases Treated:

Medulloblastoma

High-grade glioma (HGG)

Diffuse intrinsic pontine glioma (DIPG)

Eligibility:

  • Recurrent, refractory or progressive medulloblastoma, high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG)
  • Evidence of genetic activation of the MET pathway (expansion co-hort)
  • At least 5 years old and 21 years old or younger
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PEPN1812 : Study of Flotetuzumab in Children with Relapsed or Refractory Acute Myeloid Leukemia

Diseases Treated:

Acute Myeloid Leukemia (AML)

Eligibility:

  • Younger than 21 years of age
  • Diagnosed with recurrent or refractory acute myeloid leukemia (AML)
  • Weigh more than 17kg 
  • Fully recovered from the acute toxic effects of all prior anti-cancer therapy
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PNOC013: Study of REGN2810 Immunotherapy in Children with Relapsed or Refractory Solid or CNS Tumors and Study of REGN2810 combined with radiation in Children with Newly Diagnosed or Recurrent Glioma

Diseases Treated:

Diffuse Intrinsic Pontine GliomaGlioma, CNS Tumor, Solid Tumor

Eligibility:

  • Diagnosed with one of the following:
  • Younger than 18 years old (Phase I) or between 3 and 25 years old (Efficacy Phase)
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SENDAI: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity

Eligibility:

  • Child is greater than or equal to twelve (12) months and less than twenty-four (24) months.
  • Child has adequate blood, liver and kidney function.
  • Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition.
View Trial

STARTRK: Phase I/II Study of Entrectinib in Children and Young Adults with Aggressive Solid or Brain Tumors

Diseases Treated:

Solid tumors, brain tumors, CNS tumors

Eligibility:

  • Diagnosed with one of the following:
  • Relapsed or refractory extracranial solid tumor
  • Primary brain tumor with NTRK1/2/3, ROS1 or ALK gene fusion
  • Extracranial solid tumor with NTRK1/2/3, ROS1 or ALK gene fusion
  • Younger than 22 years old
  • Not pregnant
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TINI: Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL)

Diseases Treated:

Acute lymphoblastic leukemia (ALL)

Eligibility:

  • Newly diagnosed ALL
  • 1 year of age or younger at the time of diagnosis
  • Has not had any — or has had limited — prior therapy
  • Does not have mature B-cell ALL, acute myeloid leukemia (AML) or Down syndrome
View Trial