CClinicalTrials.gg
Active, not recruitingNCT04195555Updated Jul 1, 2026Results posted

Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)

A Phase 2 interventional study of Ivosidenib in Recurrent Ependymoma, Recurrent Ewing Sarcoma and Recurrent Hepatoblastoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 174 sites in 3 countries. Open to participants aged 12 Months to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
12 Months to 21 Years
Sex
All
01

Study summary

This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors, including central nervous system tumors, lymphomas and histiocytic disorders that have not responded to (refractory) or have come back after (recurrent) prior treatment that have IDH (isocitrate dehydrogenase) 1 genetic alterations (mutations). Ivosidenib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway called the IDH pathway.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with AG-120 (ivosidenib) with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the IDH1 pathway.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients treated with AG-120 (ivosidenib) with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating genetic alterations in the IDH1 pathway.

II. To obtain information about the tolerability of AG-120 (ivosidenib) in children and adolescents with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics and pharmacodynamics of AG-120 (ivosidenib) in children and adolescents with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:

I. To evaluate other biomarkers as predictors of response to AG-120 (ivosidenib) and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to AG-120 (ivosidenib) treatment.

II. To explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE:

Patients receive ivosidenib orally (PO) once daily (QD). Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

02

Conditions studied

  • Recurrent Ependymoma
  • Recurrent Ewing Sarcoma
  • Recurrent Hepatoblastoma
  • Recurrent Langerhans Cell Histiocytosis
  • Recurrent Malignant Germ Cell Tumor
  • Recurrent Malignant Glioma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Medulloblastoma
  • Recurrent Neuroblastoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Osteosarcoma
  • Recurrent Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Rhabdoid Tumor
  • Recurrent Rhabdomyosarcoma
  • Recurrent Soft Tissue Sarcoma
  • Recurrent WHO Grade 2 Glioma
  • Refractory Ependymoma
  • Refractory Ewing Sarcoma
  • Refractory Hepatoblastoma
  • Refractory Langerhans Cell Histiocytosis
  • Refractory Malignant Germ Cell Tumor
  • Refractory Malignant Glioma
  • Refractory Malignant Solid Neoplasm
  • Refractory Medulloblastoma
  • Refractory Neuroblastoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Osteosarcoma
  • Refractory Peripheral Primitive Neuroectodermal Tumor
  • Refractory Rhabdoid Tumor
  • Refractory Rhabdomyosarcoma
  • Refractory Soft Tissue Sarcoma
  • Refractory WHO Grade 2 Glioma
  • Wilms Tumor
03

Who can participate

Ages eligible
12 Months to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient must have enrolled onto APEC1621SC (NCT03155620) and must have been given a treatment assignment to MATCH to APEC1621K based on the presence of an actionable mutation as defined in APEC1621SC
  • Patients must be >= than 12 months and =\< 21 years of age at the time of study enrollment
  • Patients must have a body surface area >= 0.78 m\^2 at enrollment
  • Patients must be able to swallow intact tablets
  • Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG)+ evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)

    • Note: The following do not qualify as measurable disease:

      • Malignant fluid collections (e.g., ascites, pleural effusions)
      • Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
      • Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
      • Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
      • Previously radiated lesions that have not demonstrated clear progression post radiation
      • Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =\< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately

    • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
    • Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
    • Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1
    • Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
    • Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator
    • Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
    • Stem cell infusions (with or without total body irradiation [TBI]):

      • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
      • Autologous stem cell infusion including boost infusion: >= 42 days
    • Cellular Therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
    • Radiation therapy (XRT)/external beam Irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation

      • Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
    • Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
    • Patients must not have received prior exposure to AG-120 (ivosidenib) or other IDH1 inhibitors
  • For patients with solid tumors without known bone marrow involvement: Peripheral absolute neutrophil count (ANC) >= 1000/mm\^3 (within 7 days prior to enrollment)
  • For patients with solid tumors without known bone marrow involvement: Platelet count >= 100,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood count (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m\^2 (within 7 days prior to enrollment), or
  • A serum creatinine based on age/gender (within 7 days prior to enrollment)

    • Age 1 to \< 2 years, maximum serum creatinine (mg/dL) male 0.6, female 0.6
    • Age 2 to \< 6 years, maximum serum creatinine (mg/dL) male 0.8, female 0.8
    • Age 6 to \< 10 years, maximum serum creatinine (mg/dL) male 1, female 1
    • Age 10 to \< 13 years, maximum serum creatinine (mg/dL) male 1.2, female 1.2
    • Age 13 to \< 16 years, maximum serum creatinine (mg/dL) male 1.5, female 1.4
    • Age >= 16 years, maximum serum creatinine (mg/dL) male 1.7, female 1.4
  • Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
  • Serum glutamate-pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =\< 135 U/L. (For the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment)
  • Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
  • Corrected QT (QTc )interval =\< 450 milliseconds (within 7 days prior to enrollment)

    • Note: Patients should avoid concomitant medication known or suspected to prolong QTc interval or cause Torsades de Pointes. Patients who are receiving drugs that prolong the QTc are eligible if the drug is necessary and no alternatives are available
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  • Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0) resulting from prior therapy must be =\< grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible
  • All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breast-feeding women will not be entered on this study due to risks because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective non-hormonal contraceptive method for the duration of study treatment and for at least 1 month after last dose of AG-120 (ivosidenib). Since AG-120 (ivosidenib) may decrease concentrations of hormonal contraceptives, hormonal contraceptives are not considered effective contraception when co-administered with AG-120 (ivosidenib)
  • Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
  • Patients who are currently receiving drugs that are strong inducers or moderate to strong inhibitors of CYP3A4 are not eligible. Strong inducers or moderate to strong inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study. Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed. In addition, patients receiving sensitive or narrow therapeutic range substrates of CYP3A4 are not eligible
  • Patients with a history of progressive multifocal leukoencephalopathy are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Treatment (ivosidenib)

    Patients receive ivosidenib PO QD. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

    Drug: Ivosidenib

Interventions

  • DrugIvosidenib

    Given PO

    Also known as: AG 120, AG-120, AG120, Tibsovo

05

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR; Complete Response + Partial Response) in Pediatric Patients Treated With Ivosidenib

    A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system tumors).

    Time frame: Up to 2 years from study entry

Secondary outcomes

  1. Progression Free Survival (PFS)

    The Kaplan-Meier method will be used to estimate the 6 month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.

    Time frame: Up to 6 months from study entry

  2. Percentage of Patients Experiencing Grade 3 or Higher Adverse Events

    Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Time frame: Up to 2 years from study entry

  3. Preliminary Estimates of the Pharmacokinetics (PK) of Ivosidenib in Children and Adolescents With Relapsed or Refractory Cancer

    A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).

    Time frame: Pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 1; pre-dose on cycle 1, day 2; pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 15; and pre-dose on cycle 2, day 1 and cycle 4, day 1

  4. Preliminary Estimates of the Pharmacodynamics (PD) of Ivosidenib in Children and Adolescents With Relapsed or Refractory Cancer

    Time frame: Pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 1; pre-dose on cycle 1, day 2; pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 15; and pre-dose on cycle 2, day 1 and cycle 4, day 1

Other outcomes

  1. Biomarker Analysis

    Will evaluate other biomarkers as predictors of response to ivosidenib and whether tumors that harbor different missense mutations or fusions will demonstrate differential response to treatment. A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.

    Time frame: Up to 5 years

  2. Profiling Changes in Tumor Genomics

    Will explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. A descriptive analysis will be performed and will be summarized with simple summary statistics.

    Time frame: Baseline up to 5 years

06

Results

Posted Mar 25, 2026

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Ivosidenib)
Started3
Completed0
Not completed3
Withdrew: Progressive disease1
Withdrew: Refusal by patient/parent/guardian1
Withdrew: No treatment1

Outcome measures

PrimaryObjective Response Rate (ORR; Complete Response + Partial Response) in Pediatric Patients Treated With Ivosidenib

A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders. The revised Response Evaluation Criteria in Solid Tumors guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system tumors).

Time frame:
Up to 2 years from study entry
Reported as:
Number · percentage of participants
Objective Response Rate (ORR; Complete Response + Partial Response) in Pediatric Patients Treated With Ivosidenib
percentage of participantsTreatment (Ivosidenib)
Objective Response Rate (ORR; Complete Response + Partial Response) in Pediatric Patients Treated With Ivosidenib0 (0 to 0)
SecondaryProgression Free Survival (PFS)

The Kaplan-Meier method will be used to estimate the 6 month PFS. PFS is defined as time from initiation of protocol treatment to disease progression, recurrence, death from any cause, or date of last contact.

Time frame:
Up to 6 months from study entry

Results for this outcome have not been posted.

SecondaryPercentage of Patients Experiencing Grade 3 or Higher Adverse Events

Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Time frame:
Up to 2 years from study entry

Results for this outcome have not been posted.

SecondaryPreliminary Estimates of the Pharmacokinetics (PK) of Ivosidenib in Children and Adolescents With Relapsed or Refractory Cancer

A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).

Time frame:
Pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 1; pre-dose on cycle 1, day 2; pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 15; and pre-dose on cycle 2, day 1 and cycle 4, day 1

Results for this outcome have not been posted.

SecondaryPreliminary Estimates of the Pharmacodynamics (PD) of Ivosidenib in Children and Adolescents With Relapsed or Refractory Cancer
Time frame:
Pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 1; pre-dose on cycle 1, day 2; pre-dose, 1, 2, 3, 4, and 6-8 hours after dose on cycle 1, day 15; and pre-dose on cycle 2, day 1 and cycle 4, day 1

Results for this outcome have not been posted.

Other pre-specifiedBiomarker Analysis

Will evaluate other biomarkers as predictors of response to ivosidenib and whether tumors that harbor different missense mutations or fusions will demonstrate differential response to treatment. A descriptive analysis will be performed and will be summarized with simple summary statistics. All of these analyses will be descriptive in nature.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedProfiling Changes in Tumor Genomics

Will explore approaches to the profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid. A descriptive analysis will be performed and will be summarized with simple summary statistics.

Time frame:
Baseline up to 5 years

Results for this outcome have not been posted.

Adverse events

Collected over Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Ivosidenib)1/3 (33.3%)1/2 (50%)2/2 (100%)
Most frequent serious events
Most frequent serious events
EventTreatment (Ivosidenib)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTreatment (Ivosidenib)
NauseaGastrointestinal disorders1/2
VomitingGastrointestinal disorders1/2
FatigueGeneral disorders1/2
Blood bicarbonate decreasedInvestigations1/2
Lymphocyte count decreasedInvestigations1/2
Neutrophil count decreasedInvestigations1/2
White blood cell decreasedInvestigations1/2
HyperphosphatemiaMetabolism and nutrition disorders1/2
HeadacheNervous system disorders1/2
SeizureNervous system disorders1/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (Ivosidenib)
<=18 years2
Between 18 and 65 years1
>=65 years0
Age, Continuous
Age, Continuous(years)Treatment (Ivosidenib)
Mean16.7 ± 2.5
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Ivosidenib)
Female1
Male2
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Ivosidenib)
Hispanic or Latino0
Not Hispanic or Latino3
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Ivosidenib)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Ivosidenib)
United States3
07

Study locations

174 sites
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • Banner Children's at Desert
    Mesa, Arizona 85202, United States
  • Phoenix Childrens Hospital
    Phoenix, Arizona 85016, United States
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202-3591, United States
  • Kaiser Permanente Downey Medical Center
    Downey, California 90242, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Miller Children's and Women's Hospital Long Beach
    Long Beach, California 90806, United States
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Mattel Children's Hospital UCLA
    Los Angeles, California 90095, United States
  • Valley Children's Hospital
    Madera, California 93636, United States
  • UCSF Benioff Children's Hospital Oakland
    Oakland, California 94609, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • Lucile Packard Children's Hospital Stanford University
    Palo Alto, California 94304, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Rady Children's Hospital - San Diego
    San Diego, California 92123, United States
  • Naval Medical Center -San Diego
    San Diego, California 92134, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    Torrance, California 90502, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
    Denver, Colorado 80218, United States
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06106, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Alfred I duPont Hospital for Children
    Wilmington, Delaware 19803, United States
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
  • Broward Health Medical Center
    Fort Lauderdale, Florida 33316, United States
  • Golisano Children's Hospital of Southwest Florida
    Fort Myers, Florida 33908, United States
  • UF Health Cancer Institute - Gainesville
    Gainesville, Florida 32610, United States
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
    Hollywood, Florida 33021, United States
  • Nemours Children's Clinic-Jacksonville
    Jacksonville, Florida 32207, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Miami, Florida 33136, United States
  • Nicklaus Children's Hospital
    Miami, Florida 33155, United States
  • Miami Cancer Institute
    Miami, Florida 33176, United States
  • AdventHealth Orlando
    Orlando, Florida 32803, United States
  • Arnold Palmer Hospital for Children
    Orlando, Florida 32806, United States
  • Nemours Children's Hospital
    Orlando, Florida 32827, United States
  • Sacred Heart Hospital
    Pensacola, Florida 32504, United States
  • Johns Hopkins All Children's Hospital
    St. Petersburg, Florida 33701, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • Saint Joseph's Hospital/Children's Hospital-Tampa
    Tampa, Florida 33607, United States
  • Saint Mary's Medical Center
    West Palm Beach, Florida 33407, United States
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital
    Atlanta, Georgia 30329, United States
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois 60611, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • OSF Children's Hospital of Illinois
    Peoria, Illinois 61637, United States
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • Ascension Saint Vincent Indianapolis Hospital
    Indianapolis, Indiana 46260, United States
  • Blank Children's Hospital
    Des Moines, Iowa 50309, United States
  • University of Iowa/Holden Comprehensive Cancer Center
    Iowa City, Iowa 52242, United States
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
  • Norton Children's Hospital
    Louisville, Kentucky 40202, United States
  • Children's Hospital New Orleans
    New Orleans, Louisiana 70118, United States
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • Eastern Maine Medical Center
    Bangor, Maine 04401, United States
  • Maine Children's Cancer Program
    Scarborough, Maine 04074, United States
  • University of Maryland/Greenebaum Cancer Center
    Baltimore, Maryland 21201, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • UMass Memorial Medical Center - University Campus
    Worcester, Massachusetts 01655, United States
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
  • Children's Hospital of Michigan
    Detroit, Michigan 48201, United States
  • Wayne State University/Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Michigan State University
    East Lansing, Michigan 48823, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
    Grand Rapids, Michigan 49503, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • Corewell Health Children's
    Royal Oak, Michigan 48073, United States
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
    Minneapolis, Minnesota 55404, United States
  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Children's Mercy Hospitals and Clinics
    Kansas City, Missouri 64108, United States
  • Cardinal Glennon Children's Medical Center
    St Louis, Missouri 63104, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Mercy Hospital Saint Louis
    St Louis, Missouri 63141, United States
  • Children's Hospital and Medical Center of Omaha
    Omaha, Nebraska 68114, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • University Medical Center of Southern Nevada
    Las Vegas, Nevada 89102, United States
  • Sunrise Hospital and Medical Center
    Las Vegas, Nevada 89109, United States
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
    Las Vegas, Nevada 89135, United States
  • Summerlin Hospital Medical Center
    Las Vegas, Nevada 89144, United States
  • Renown Regional Medical Center
    Reno, Nevada 89502, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
    Lebanon, New Hampshire 03756, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Morristown Medical Center
    Morristown, New Jersey 07960, United States
  • Saint Peter's University Hospital
    New Brunswick, New Jersey 08901, United States
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
    New Brunswick, New Jersey 08903, United States
  • Albany Medical Center
    Albany, New York 12208, United States

Showing the first 100 of 174 sites across 3 countries.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 28, 2022
  • Informed consent form · Oct 28, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

09

Registry details

Key details

Study ID
NCT04195555
Lead sponsor
National Cancer Institute (NCI)
Collaborators
Children's Oncology Group
Responsible party
Sponsor
First posted
Dec 12, 2019
Start date
Jul 20, 2020
Primary completion
Mar 31, 2025
Completion
May 9, 2027 (estimated)
Results posted
Mar 25, 2026
Last update
Jul 1, 2026

Study contacts

Elizabeth D Alva
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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