Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma
NCT ID: NCT03117751
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
790 participants
INTERVENTIONAL
2017-03-29
2028-09-30
Brief Summary
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Primary Therapeutic Objectives:
* To improve the event-free survival of provisional standard- or high-risk patients with genetically or immunologically targetable lesions or minimal residual disease (MRD) ≥ 5% at Day 15 or Day 22 or ≥1% at the end of Remission Induction, by the addition of molecular and immunotherapeutic approaches including tyrosine kinase inhibitors or chimeric antigen receptor (CAR) T cell / blinatumomab for refractory B-acute lymphoblastic leukemia (B-ALL) or B-lymphoblastic lymphoma (B-LLy), and the proteasome inhibitor bortezomib for those lacking targetable lesions.
* To improve overall treatment outcome of T acute lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LLy) by optimizing pegaspargase and cyclophosphamide treatment and by the addition of new agents in patients with targetable genomic abnormalities (e.g., activated tyrosine kinases or JAK/STAT mutations) or by the addition of bortezomib for those who have a poor early response to treatment but no targetable lesions, and by administering nelarabine to T-ALL and T-LLy patients with leukemia/lymphoma cells in cerebrospinal fluid at diagnosis or MRD ≥0.01% at the end of induction.
* To determine in a randomized study design whether the incidence and/or severity of acute vincristine-induced peripheral neuropathy can be reduced by decreasing the dosage of vincristine in patients with the high-risk CEP72 TT genotype or by shortening the duration of vincristine therapy in standard/high-risk patients with the CEP72 CC or CT genotype.
Secondary Therapeutic Objectives:
* To estimate the event-free survival and overall survival of children with ALL and to assess the non-inferiority of TOTXVII compared to the historical control given by TOTXVI.
* To estimate the event-free survival and overall survival of children with LLy when ALL diagnostic and treatment approaches are used.
* To evaluate the efficacy of blinatumomab in B-ALL patients with end of induction MRD ≥0.01% to \<1% and those (regardless of MRD level or TOTXVII risk category) with the genetic subtypes of BCR-ABL1, ABL-class fusion, JAK-STAT activating mutation, hypodiploid, iAMP21, ETV6-RUNX1-like, MEF2D, TCF3-HLF, or BCL2/MYC or with Down syndrome, by comparing event-free survival to historical control from TOTXVI.
* To determine the tolerability of combination therapy with ruxolitinib and Early Intensification therapy in patients with activation of JAK-STAT signaling that can be inhibited by ruxolitinib and Day 15 or Day 22 MRD ≥5%, Day 42 MRD ≥1%, or LLy patients without complete response at the End of Induction and all patients with early T cell precursor leukemia.
Biological Objectives:
* To use data from clinical genomic sequencing of diagnosis, germline/remission and MRD samples to guide therapy, including incorporation of targeted agents and institution of genetic counseling and cancer surveillance.
* To evaluate and implement deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sequencing-based methods to monitor levels of MRD in bone marrow, blood, and cerebrospinal fluid.
* To assess clonal diversity and evolution of pre-leukemic and leukemic populations using DNA variant detection and single-cell genomic analyses in a non-clinical, research setting.
* To identify germline or somatic genomic variants associated with drug resistance of ALL cells to conventional and newer targeted anti-leukemic agents in a non-clinical, research setting.
* To compare drug sensitivity of ALL cells from diagnosis to relapse in vitro and in vivo and determine if acquired resistance to specific agents is related to specific somatic genome variants that are not detected or found in only a minor clone at initial diagnosis.
Supportive Care Objectives
* To conduct serial neurocognitive monitoring of patients to investigate the neurocognitive trajectory, mechanisms, and risk factors.
* To evaluate the impact of low-magnitude high frequency mechanical stimulation on bone mineral density and markers of bone turnover.
There are several Exploratory Objectives.
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Detailed Description
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Treatment will consist of three main phases: Remission Induction, Consolidation, and Continuation. Early Intensification therapy will be given prior to Consolidation to patients with provisional standard-risk or high-risk ALL/LLy or any provisional low-risk patients with Day 15 MRD ≥1% as well as provisional low-risk LLy patients who do not obtain complete response at the end of Induction. Patients with mixed phenotype acute leukemia (MPAL) are treated by using the same treatment stratification used in ALL although analysis is performed separately from ALL or LLy cohorts.
Brief outline of treatment plan:
Patients will be assigned to treatment based on risk group: Low-Risk, Standard-Risk and High-Risk and cell type (T or B cell).
Remission Induction initially consists of prednisone (28 days), vincristine (4 weekly doses), daunorubicin (1 to 3 weekly doses), and pegaspargase 1 dose for all patients and 2 doses for those with Day 15 MRD 1% or higher. The second part (given over 2 weeks and overlapping with the last week of the first part of induction) consists of cyclophosphamide, cytarabine, and mercaptopurine combinations. Dasatinib will be added for patients with Ph+ and Ph-like ABL-class fusions and bortezomib will be given to patients with no targetable lesions and Day 15 or Day 22 minimal residual disease (MRD) ≥ 5% on Days 29 and 32.
Early Intensification will be given prior to Consolidation to patients with provisional standard-risk or high-risk ALL/LLy or any provisional low-risk patients with Day 15 MRD ≥1% as well as provisional low-risk LLy patients who do not obtain complete response at the end of Induction. For patients with Ph-like ALL that is targetable with JAK inhibitor and Day 15 or Day 22 MRD level ≥5% or end of Remission Induction ≥1% as well as all patients with early T cell precursor (ETP) ALL and T/M MPAL, ruxolitinib will be used. This includes, but is not limited to CRLF2, JAK2, and EPOR rearrangements and sequence/structural changes in JAK1/2, TYK2, IL7R, and SH2B3. Ruxolitinib will be added in LLy patients with activation of JAK-STAT signaling that can be inhibited by ruxolitinib whose responses do not qualify complete response at the end of Remission Induction. Dasatinib will continue for patients with ABL-class fusions. Bortezomib will be added for patients with no targetable lesions and Day 15 or Day 22 MRD ≥ 5% or LLy patients without complete response at the End of Induction.
Consolidation Treatment will consist of high dose methotrexate (HDMTX) (every other week for 4 doses); daily mercaptopurine and IT chemotherapy on the same dates of HDMTX. Dasatinib will continue for patients with ABL-class fusions. Ruxolitinib will continue for patients with activation of JAK-STAT signaling that can be inhibited by ruxolitinib and Day 15 or Day 22 MRD ≥5% or Day 42 MRD ≥1% (or for LLy patients who do not qualify complete response at the end of Remission Induction) and all cases with ETP ALL and T/M MPAL.
Immunotherapy: CAR T-cell therapy will be considered for High-risk B-ALL and B-LLy patients. Blinatumomab will be given to patients with Standard-risk B-ALL and B-LLy with residual disease at the end of induction and High-risk B-ALL and B-LLy patients who are not able to receive CAR T-cell therapy. Blinatumomab is also given to patients with the following genetic subtypes (BCR-ABL1, ABL-class fusion, JAK-STAT activating mutation, hypodiploid, iAMP21, ETV6-RUNX1-like, MEF2D, TCF3/HLF, or BCL2/MYC) or with Down syndrome, regardless of MRD level and/or Total 17 risk category.
Reintensification therapy will be offered to certain High-risk patients with persistent MRD after Immunotherapy (B-ALL and B-LLy) or Early Intensification (T-ALL and T-LLy), or those who cannot receive Immunotherapy.
Continuation Treatment will consist of 120 weeks of risk-directed therapy. Dasatinib will continue in patients with ABL-class fusion. Ruxolitinib will continue in patients with activation of JAK-STAT signaling that can be inhibited by ruxolitinib and Day 15 or Day 22 MRD ≥5% or Day 42 MRD ≥1% (or for LLy patients who do not qualify complete response at the end of Remission Induction) and all cases with ETP ALL. T-ALL and T-LLy patients with leukemia/lymphoma cells in cerebrospinal fluid at diagnosis or MRD ≥0.01% at the end of Induction will receive nelarabine. ALL/LLy Patients with the CEP72 rs904627T/T genotype (16% of patients) will be randomized (unblinded design except those who evaluate neuropathies) to receive either 1.5 mg/m2 or 1 mg/m2 of vincristine after Continuation Week 1. Patients in low- risk will complete vincristine in Week 49 and those in standard/high-risk will complete in Week 101. Standard/high-risk patients with either a CEP72 rs904627 C/T or C/C genotype (84% of patients) will be randomized to receive vincristine and dexamethasone pulses through Week 49 of Continuation Treatment or through Week 101 of Continuation Treatment. Low-risk patients will complete vincristine in Week 49.
Intrathecal therapy is given throughout the treatment. The number of intrathecal therapy is based on the risk factors of central nervous system relapse.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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B-ALL and B-LLy, Low-risk
Patients with low-risk B ALL and LLy will have Induction (6 weeks), Consolidation (8 weeks), and Continuation (120 weeks). During Remission Induction therapy, prednisone dose is 40mg/m\^2 and 1-2 doses of daunorubicin (based on day 8 peripheral blood MRD in patients with ETV6-RUNX1 or hyperdiploid) are given. Dasatinib is given for patients with ABL-class fusion. Blinatumomab will be given to patients with certain genetic subtypes and those with Down syndrome.
Interventions: Prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, thioguanine, methotrexate, dexamethasone, blinatumomab.
Prednisone
Given orally (PO).
Vincristine
Given intravenously (IV).
Daunorubicin
Given IV.
Pegaspargase
Given IV or intramuscularly (IM) .
Erwinase®
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV or intramuscularly (IM).
Cyclophosphamide
Given IV.
Cytarabine
Given IV or by subcutaneous injection (SQ).
Mercaptopurine
Given PO.
Dasatinib
Given PO.
Methotrexate
Given IV.
Blinatumomab
Given IV.
Dexamethasone
Given PO.
Thioguanine
Participants with mercaptopurine-related pancreatitis. Given PO.
Asparaginase Erwinia chrysanthemi (recombinant)-rywn
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given intramuscularly (IM).
Calaspargase Pegol
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV.
B-ALL and B-LLy, Standard-risk
Induction (6wks), Early Intensification (4wks), Consolidation (8wks) and Continuation (120 wks). Remission Induction: Prednisone dose is 40mg/m\^2 and 2 doses daunorubicin are given. Dasatinib: given for patients with Ph+ and those with ABL-class fusion. Ruxolitinib: given for patients with activation of JAK-STAT signaling; ALL patients with Day 15 or Day 22 MRD ≥5%, LLy patients who don't qualify for complete response at end of Remission Induction and all patients with ETP and T/M MPAL. Bortezomib is given to patients without targetable lesions and Day 15 or Day 22 MRD \>5%. Blinatumomab will be given to patients with residual disease at the end of induction (≥0.01% and \<1%), certain genetic subtypes and Down syndrome.
Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, blinatumomab, thioguanine, methotrexate, dexamethasone, doxorubicin
Prednisone
Given orally (PO).
Vincristine
Given intravenously (IV).
Daunorubicin
Given IV.
Pegaspargase
Given IV or intramuscularly (IM) .
Erwinase®
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV or intramuscularly (IM).
Cyclophosphamide
Given IV.
Cytarabine
Given IV or by subcutaneous injection (SQ).
Mercaptopurine
Given PO.
Dasatinib
Given PO.
Methotrexate
Given IV.
Blinatumomab
Given IV.
Ruxolitinib
Given PO.
Bortezomib
Given IV or subcutaneously (SQ).
Dexamethasone
Given PO.
Doxorubicin
Given IV.
Thioguanine
Participants with mercaptopurine-related pancreatitis. Given PO.
Asparaginase Erwinia chrysanthemi (recombinant)-rywn
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given intramuscularly (IM).
Calaspargase Pegol
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV.
B-ALL and B-LLy, High-risk
Induction (6 weeks), Early Intensification (4 weeks), Consolidation (8 weeks), and Immunotherapy (chimeric antigen receptor \[CAR\] T cells). Patients who do not respond to Immunotherapy will receive Reintensification therapy. During Remission Induction therapy, prednisone dose is 40mg/m\^2 and 2 doses of daunorubicin are given. Dasatinib, ruxolitinib, and bortezomib are given as done for patients with standard-risk B-ALL but are discontinued in Immunotherapy and Reintensification therapy. Blinatumomab will be given to patients who are not able to receive CAR T cell therapy and patients with certain genetic subtypes and those with Down syndrome.
Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, blinatumomab, etoposide, dexamethasone, clofarabine, thioguanine, methotrexate.
Prednisone
Given orally (PO).
Vincristine
Given intravenously (IV).
Daunorubicin
Given IV.
Pegaspargase
Given IV or intramuscularly (IM) .
Erwinase®
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV or intramuscularly (IM).
Cyclophosphamide
Given IV.
Cytarabine
Given IV or by subcutaneous injection (SQ).
Mercaptopurine
Given PO.
Dasatinib
Given PO.
Methotrexate
Given IV.
Blinatumomab
Given IV.
Ruxolitinib
Given PO.
Bortezomib
Given IV or subcutaneously (SQ).
Dexamethasone
Given PO.
Etoposide
Given IV.
Clofarabine
Given IV.
Thioguanine
Participants with mercaptopurine-related pancreatitis. Given PO.
Asparaginase Erwinia chrysanthemi (recombinant)-rywn
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given intramuscularly (IM).
Calaspargase Pegol
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV.
T-ALL and T-LLy, Standard-risk
Induction (6 wks), Early Intensification (4 wks), Consolidation (8 wks), and Continuation (120 wks). During Remission Induction therapy, prednisone dose is 60mg/m\^2 and 3 doses daunorubicin are given. Dasatinib is given for patients with Ph+ and those with ABL-class fusion. Ruxolitinib is given for patients with activation of JAK-STAT signaling; ALL patients with Day 15 or Day 22 MRD ≥5% and all patients with ETP and T/M MPAL and LLy patients who don't qualify for complete response at end of Remission Induction. Bortezomib is given to patients without targetable lesions and Day 15 or Day 22 MRD ≥ 5%.
Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, methotrexate, dexamethasone, doxorubicin, nelarabine, thioguanine.
Prednisone
Given orally (PO).
Vincristine
Given intravenously (IV).
Daunorubicin
Given IV.
Pegaspargase
Given IV or intramuscularly (IM) .
Erwinase®
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV or intramuscularly (IM).
Cyclophosphamide
Given IV.
Cytarabine
Given IV or by subcutaneous injection (SQ).
Mercaptopurine
Given PO.
Dasatinib
Given PO.
Methotrexate
Given IV.
Ruxolitinib
Given PO.
Bortezomib
Given IV or subcutaneously (SQ).
Dexamethasone
Given PO.
Doxorubicin
Given IV.
Nelarabine
Given IV.
Thioguanine
Participants with mercaptopurine-related pancreatitis. Given PO.
Asparaginase Erwinia chrysanthemi (recombinant)-rywn
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given intramuscularly (IM).
Calaspargase Pegol
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV.
T-ALL and T-LLy, High-risk
Induction (6 wks), Early Intensification (4 wks), Consolidation (8 wks), and Reintensification. During Remission Induction therapy, prednisone dose is 60mg/m\^2 and 3 doses daunorubicin are given. Dasatinib, ruxolitinib, and bortezomib given as done for patients with standard-risk T-ALL but are discontinued in Reintensification therapy.
Interventions: prednisone, vincristine, daunorubicin, pegaspargase (or Erwinase®, Rylaze™ or Calaspargase pegol), cyclophosphamide, cytarabine, mercaptopurine, dasatinib, bortezomib, ruxolitinib, methotrexate, etoposide, dexamethasone, clofarabine, vorinostat, idarubicin, nelarabine, thioguanine..
Prednisone
Given orally (PO).
Vincristine
Given intravenously (IV).
Daunorubicin
Given IV.
Pegaspargase
Given IV or intramuscularly (IM) .
Erwinase®
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV or intramuscularly (IM).
Cyclophosphamide
Given IV.
Cytarabine
Given IV or by subcutaneous injection (SQ).
Mercaptopurine
Given PO.
Dasatinib
Given PO.
Methotrexate
Given IV.
Ruxolitinib
Given PO.
Bortezomib
Given IV or subcutaneously (SQ).
Dexamethasone
Given PO.
Etoposide
Given IV.
Clofarabine
Given IV.
Vorinostat
Given PO.
Idarubicin
Given IV.
Nelarabine
Given IV.
Thioguanine
Participants with mercaptopurine-related pancreatitis. Given PO.
Asparaginase Erwinia chrysanthemi (recombinant)-rywn
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given intramuscularly (IM).
Calaspargase Pegol
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV.
ALL, CEP72 T/T, Vincristine
Patients with the CEP72 rs904627T/T genotype (\~16% of patients) will be randomized (unblinded design, only those who evaluate neuropathy are blinded) to receive either 1.5 mg/m\^2 or 1 mg/m\^2 of vincristine after Continuation Week 1. Patients in low- risk will complete vincristine in Week 49 and those in standard/high-risk will complete in Week 101.
Intervention: vincristine.
Vincristine
Given intravenously (IV).
ALL, CEP72 C/T or C/C, Vincristine
Patients with either a CEP72 rs904627 C/T or C/C genotype (\~84% of patients) will be randomized (unblinded design, only those who evaluate neuropathy are blinded) to receive vincristine (2 mg/m\^2 per dose except during Reinduction I and Reinduction II when 3 weekly doses of 1.5 mg/m\^2 will be given) and dexamethasone pulses through Week 49 of Continuation Treatment or through Week 101 of Continuation Treatment. Patients at low-risk will complete vincristine in Week 49.
Interventions: vincristine, dexamethasone, methotrexate, mercaptopurine.
Vincristine
Given intravenously (IV).
Mercaptopurine
Given PO.
Methotrexate
Given IV.
Dexamethasone
Given PO.
Interventions
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Prednisone
Given orally (PO).
Vincristine
Given intravenously (IV).
Daunorubicin
Given IV.
Pegaspargase
Given IV or intramuscularly (IM) .
Erwinase®
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV or intramuscularly (IM).
Cyclophosphamide
Given IV.
Cytarabine
Given IV or by subcutaneous injection (SQ).
Mercaptopurine
Given PO.
Dasatinib
Given PO.
Methotrexate
Given IV.
Blinatumomab
Given IV.
Ruxolitinib
Given PO.
Bortezomib
Given IV or subcutaneously (SQ).
Dexamethasone
Given PO.
Doxorubicin
Given IV.
Etoposide
Given IV.
Clofarabine
Given IV.
Vorinostat
Given PO.
Idarubicin
Given IV.
Nelarabine
Given IV.
Thioguanine
Participants with mercaptopurine-related pancreatitis. Given PO.
Asparaginase Erwinia chrysanthemi (recombinant)-rywn
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given intramuscularly (IM).
Calaspargase Pegol
To be used in case of hypersensitivity or intolerance to Pegaspargase or if Pegaspargase is not available. Given IV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* LLy participants must have \< 25% tumor cells in bone marrow and peripheral blood by morphology and flow cytometry. If any of these show ≥25% blasts, patient will be considered to have leukemia. Patients with MPAL are eligible.
* Age 1-18 years (inclusive).
* No prior therapy, or limited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy (e.g., to the mediastinum, head and neck, orbit, etc.) and one dose of intrathecal chemotherapy.
* Written, informed consent and assent following Institutional Review Board (IRB), National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) Guidelines.
Exclusion Criteria
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
1 Year
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Amgen
INDUSTRY
Servier
INDUSTRY
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Hiroto Inaba, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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Lucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Children's Hospital of Illinois at OSF-Saint Francis Medical Center (St. Jude Midwest Affiliate - Peoria)
Peoria, Illinois, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital
Charlotte, North Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
The Royal Children's Hospital Melbourne
Parkville, Victoria, Australia
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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St. Jude Children's Research Hospital
ClinicalTrials Open at St. Jude
Other Identifiers
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NCI-2017-00582
Identifier Type: REGISTRY
Identifier Source: secondary_id
TOT17
Identifier Type: -
Identifier Source: org_study_id
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