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Phase I / II Clinical Trials

 

St. Jude Clinical Trials

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
  • HIV negative
  • Not pregnant or breastfeeding

Recipient eligibility includes:

  • 21 years old or younger*
  • Diagnosed with relapsed and/or refractory CD19-positive leukemia
  • Cohort A only – Relapsed and/or refractory CD19-positive leukemia AND previously received a hematopoietic cell transplant from the selected CAR-T donor
  • Cohort B only: Can not receive autologous CD19-CAR T-cell therapy (per study)
  • Detectable medullary leukemia

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

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NRSTS2021: A Risk Adapted Study Using Pazopanib, Radiation Therapy, and Selinexor for Non-Rhabdomyosarcoma Soft Tissue Sarcoma

Diseases Treated:

Non-rhabdomyosarcoma soft tissue sarcoma

Adipocytic neoplasm

Liposarcoma

Synovial sarcoma

MPNST

Undifferentiated Sarcoma

Eligibility:

  • Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma
  • Up to 30 years old 
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ONITT: Study of Onivyde with Talazoparib or Temozolomide in Children and Young Adults with Recurrent/Refractory Solid Tumors and Ewing Sarcoma

Diseases Treated:

Solid tumors
Ewing sarcoma

Eligibility:

  • Ages 12 months old to 30 years
  • Diagnosed with recurrent or refractory solid tumor (Phase 1)
  • Diagnosed with recurrent or refractory Ewing sarcoma (Phase 2)
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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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RMS2021: Treatment of Intermediate- and High-risk Pediatric Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan

Diseases Treated:

Rhabdomyosarcoma

Eligibility:

  • Newly diagnosed with rhabdomyosarcoma (RMS) of any subtype
  • Low-risk, intermediate-risk, or high-risk disease, as defined in the research protocol
  • Up to 21 years old
  • No prior radiotherapy or chemotherapy
  • No active infection
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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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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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Collaborative Clinical Trials

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 OR
  • Between 12 and 18 years old with a diagnosis of Stage IIB, IIC, III, or IV melanoma, who had prior surgery to remove the tumor, but no other treatment (including radiation), no metastatic disease, and who have completely recovered. 
  • Negative pregnancy test 72 hours prior to medication administration in participants of child-bearing potential
  • Appropriate liver and kidney functions
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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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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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