Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Study Details
Study Description
Brief Summary
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVE:
- To determine if nivolumab + chemo-immunotherapy results in a superior long term progression-free survival (PFS) (events defined as disease progression confirmed by central review or death) when compared with chemo-immunotherapy alone in patients with newly diagnosed primary mediastinal B-cell lymphoma.
SECONDARY OBJECTIVES:
-
To compare the rates of "efficacy-related event-free survival (EFS)" (eEFS) (events defined as progression, change in therapy due to finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, or death) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.
-
To compare the rates of "therapy-related EFS" (tEFS) (events defined as relapse/progression, change in therapy for any reason, biopsy + disease after 6 cycles of therapy, secondary malignancy [SMN] or death) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.
-
To compare the rates of overall survival (OS) between chemo-immunotherapy alone and chemo-immunotherapy + nivolumab in patients with newly diagnosed PMBCL.
-
To establish the rate of a positive positron emission tomography (PET)-computed tomography (CT) (defined as Deauville score 4 or 5) at the completion of 6 cycles of nivolumab + rituximab (R)- cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)/dose-adjusted (DA)-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)-R and R-CHOP/DA-EPOCH-R in patients with newly diagnosed PMBCL and evaluate the prognostic significance of such a finding.
EXPLORATORY OBJECTIVES:
-
To bank radiology images for further studies. II. To bank specimens for future correlative studies. III. Characterize the immune profile of patients treated with nivolumab + chemo-immunotherapy to identify markers predictive of response.
-
Define the rate of complete response at the completion of initial planned therapy.
OUTLINE: Patients are randomly assigned to backbone therapy or backbone therapy + nivolumab within each of 6 strata. The strata are determined by physician's choice of backbone (DA-EPOCH-R vs. R-CHOP vs. R-CHOP + RT) and whether or not the patient had 1 prior cycle of therapy.
ARM A (DA-EPOCH-R): Patients receive prednisone or prednisolone orally (PO) once daily (QD) on days 1-5 and rituximab intravenously (IV) or rituximab and hyaluronidase human subcutaneously (SC) over 5 minutes on day 1 or 5. Patients also receive etoposide phosphate, doxorubicin hydrochloride, and vincristine sulfate IV over 96 hours on days 1-4 and cyclophosphamide IV over 30-60 minutes on day 5. Beginning 24-72 hours after completing cyclophosphamide, patients receive filgrastim or pegylated filgrastim SC daily until absolute neutrophil count (ANC) is >= 500/uL after the expected nadir. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity.
ARM B (DA-EPOCH-R + NIVOLUMAB): Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1.
ARM C (R-CHOP): Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity.
ARM D (R-CHOP + NIVOLUMAB): Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1.
ARM E (R-CHOP + RADIOTHERAPY): Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions.
ARM F (R-CHOP + RADIOTHERAPY + NIVOLUMAB): Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions.
After completion of study treatment, patients are followed up every 3 months for year 1, every 6 months for years 2-3, and annually thereafter.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm A (DA-EPOCH-R) Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive etoposide phosphate, doxorubicin hydrochloride, and vincristine sulfate IV over 96 hours on days 1-4 and cyclophosphamide IV over 30-60 minutes on day 5. Beginning 24-72 hours after completing cyclophosphamide, patients receive filgrastim or pegylated filgrastim SC daily until ANC is >= 500/uL after the expected nadir. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. |
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Drug: Etoposide Phosphate
Given IV
Other Names:
Biological: Filgrastim
Given SC
Other Names:
Biological: Pegfilgrastim
Given SC
Other Names:
Drug: Prednisolone
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
Biological: Rituximab
Given IV
Other Names:
Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
| Experimental: Arm B (DA-EPOCH-R, nivolumab) Patients receive treatment as in Arm A. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. |
Drug: Cyclophosphamide
Given IV
Other Names:
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Drug: Etoposide Phosphate
Given IV
Other Names:
Biological: Filgrastim
Given SC
Other Names:
Biological: Nivolumab
Given IV
Other Names:
Biological: Pegfilgrastim
Given SC
Other Names:
Drug: Prednisolone
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
Biological: Rituximab
Given IV
Other Names:
Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
| Active Comparator: Arm C (R-CHOP) Patients receive prednisone or prednisolone PO QD on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV over 1-15 minutes or up to 60 minutes, and vincristine sulfate IV over 1 or up to 60 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. |
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Drug: Prednisolone
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
Biological: Rituximab
Given IV
Other Names:
Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
| Experimental: Arm D (R-CHOP, nivolumab) Patients receive treatment as in Arm C. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. |
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Biological: Nivolumab
Given IV
Other Names:
Drug: Prednisolone
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
Biological: Rituximab
Given IV
Other Names:
Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
| Active Comparator: Arm E (R-CHOP, radiation therapy) Patients receive treatment as in Arm C. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. |
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Drug: Prednisolone
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
Biological: Rituximab
Given IV
Other Names:
Drug: Vincristine Sulfate
Given IV
Other Names:
|
| Experimental: Arm F (R-CHOP, nivolumab, radiation therapy) Patients receive treatment as in Arm D. Within 6-8 weeks after completion of chemotherapy, patients undergo radiation therapy over 25 fractions. |
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
Biological: Nivolumab
Given IV
Other Names:
Drug: Prednisolone
Given PO
Other Names:
Drug: Prednisone
Given PO
Other Names:
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
Biological: Rituximab
Given IV
Other Names:
Biological: Rituximab and Hyaluronidase Human
Given SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival (PFS) [From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 5 years]
The primary analysis will be a one-sided Log-rank test stratified by choice of backbone and radiation therapy and whether the patient had a cycle of therapy prior to enrolling.
Secondary Outcome Measures
- Efficacy-related event-free survival [Up to 5 years]
Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.
- Therapy-related event-free survival [Up to 5 years]
Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.
- Overall survival [Up to 5 years]
Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as only death.
- Proportion of positive positron emission tomography (PET) scans [Up to 6 cycle (1 cycle = 21 days)]
Will be analyzed descriptively with a point estimate and Clopper-Pearson 95% confidence interval in the trial overall and in each treatment arm separately. The prognostic significance of positive PET after 6 cycles of therapy will be evaluated using a Cox proportional hazards regression on PFS with PET result (positive versus [vs.] negative), choice of backbone (rituximab [R]-cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] + radiation therapy [RT] regardless of end-of-therapy imaging vs. R-CHOP without RT unless biopsy positive at end-of-therapy vs. dose-adjusted [DA]-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin [EPOCH]-R without RT unless biopsy positive at end of therapy), and assignment to nivolumab (yes vs. no) as covariates.
Other Outcome Measures
- Immune profile of patients treated with nivolumab + chemo-immunotherapy [Up to 5 years]
Analysis will be by paired t-test (for pre- vs. post-treatment measurements) or two-sample equal-variance t-test (for comparisons of nivolumab vs. non-nivolumab or responders [complete response/partial response] vs. non-responders [stable disease/progressive disease]).
- Complete response rate [At the completion of initial planned therapy]
Will be described using point estimates and Clopper-Pearson 95% confidence intervals for the complete response rate overall and in each treatment arm separately.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age >= 2 years
-
Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma
-
Children's Oncology Group (COG) Institutions: Use Karnofsky for patients >= 17 and < 18 years of age and Lansky for patients < 17 years of age
-
Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
-
Pediatric Patients (age < 18 years): The following must have been obtained within 14 days prior to registration:
-
Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or
-
Serum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/gender as follows:
-
Age : 2 to < 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female)
-
Age : 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female)
-
Age : 10 to < 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female)
-
Age : 13 to < 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female)
-
Age : >= 16 years to < 18 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female)
-
Patients with abnormal liver function will be eligible to enroll if the lab abnormality is thought to be due to the lymphoma or Gilbert's syndrome
-
Age >= 18 years: Ejection fraction of >= 50% by echocardiogram
-
Age < 18 years: Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by radionuclide angiogram
-
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
-
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
-
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
-
All patients and/or their parents or legal guardians must sign a written informed consent
-
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
-
Administration of prior anti-cancer therapy except as outlined below:
-
A short course (=< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms
-
A single course of COP (cyclophosphamide, vincristine, and prednisone)
-
One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, or a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131) that has not started more than 21 days prior to enrollment
-
Active ischemic heart disease or heart failure
-
Active uncontrolled infection
-
Central nervous system (CNS) involvement of lymphoma
-
Previous cancer that required systemic chemotherapy and/or thoracic radiation. Other cancers will be permitted if in remission x 3 years
-
Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment
-
In patients < 18 years of age hepatitis B serologies consistent with past or current infections
-
Patients with severe hepatic impairment (Child-Pugh class C or serum total bilirubin > 5.0 mg/dL) unless thought to be due to lymphoma or Gilbert's syndrome
-
Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
-
Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of < 1% per year when used consistently and correctly) for the duration of their study participation
-
Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last dose of rituximab
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital of Alabama | Birmingham | Alabama | United States | 35233 |
| 2 | USA Health Strada Patient Care Center | Mobile | Alabama | United States | 36604 |
| 3 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 4 | Banner Children's at Desert | Mesa | Arizona | United States | 85202 |
| 5 | Banner University Medical Center - Tucson | Tucson | Arizona | United States | 85719 |
| 6 | Arkansas Children's Hospital | Little Rock | Arkansas | United States | 72202-3591 |
| 7 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 8 | Children's Hospital Los Angeles | Los Angeles | California | United States | 90027 |
| 9 | Mattel Children's Hospital UCLA | Los Angeles | California | United States | 90095 |
| 10 | Valley Children's Hospital | Madera | California | United States | 93636 |
| 11 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
| 12 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 13 | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 14 | Lucile Packard Children's Hospital Stanford University | Palo Alto | California | United States | 94304 |
| 15 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 16 | Rady Children's Hospital - San Diego | San Diego | California | United States | 92123 |
| 17 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 18 | Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 19 | Connecticut Children's Medical Center | Hartford | Connecticut | United States | 06106 |
| 20 | Alfred I duPont Hospital for Children | Wilmington | Delaware | United States | 19803 |
| 21 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 22 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 23 | Broward Health Medical Center | Fort Lauderdale | Florida | United States | 33316 |
| 24 | University of Florida Health Science Center - Gainesville | Gainesville | Florida | United States | 32610 |
| 25 | Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | United States | 33021 |
| 26 | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | United States | 32207 |
| 27 | Arnold Palmer Hospital for Children | Orlando | Florida | United States | 32806 |
| 28 | Nemours Children's Hospital | Orlando | Florida | United States | 32827 |
| 29 | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | United States | 33607 |
| 30 | Emory Proton Therapy Center | Atlanta | Georgia | United States | 30308 |
| 31 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
| 32 | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | United States | 30322 |
| 33 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 34 | Emory Saint Joseph's Hospital | Atlanta | Georgia | United States | 30342 |
| 35 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 36 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96826 |
| 37 | Saint Luke's Cancer Institute - Boise | Boise | Idaho | United States | 83712 |
| 38 | Rush - Copley Medical Center | Aurora | Illinois | United States | 60504 |
| 39 | Lurie Children's Hospital-Chicago | Chicago | Illinois | United States | 60611 |
| 40 | University of Illinois | Chicago | Illinois | United States | 60612 |
| 41 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 42 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 43 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 44 | Carle Physician Group-Effingham | Effingham | Illinois | United States | 62401 |
| 45 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 46 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 47 | Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | United States | 60453 |
| 48 | Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | United States | 60068 |
| 49 | Saint Jude Midwest Affiliate | Peoria | Illinois | United States | 61637 |
| 50 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 51 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 52 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 53 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
| 54 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 55 | Norton Children's Hospital | Louisville | Kentucky | United States | 40202 |
| 56 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 57 | Eastern Maine Medical Center | Bangor | Maine | United States | 04401 |
| 58 | Maine Children's Cancer Program | Scarborough | Maine | United States | 04074 |
| 59 | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | United States | 21287 |
| 60 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 61 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 62 | C S Mott Children's Hospital | Ann Arbor | Michigan | United States | 48109 |
| 63 | Michigan State University Clinical Center | East Lansing | Michigan | United States | 48824-7016 |
| 64 | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 65 | Beaumont Children's Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 66 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 67 | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | United States | 55404 |
| 68 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 69 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 70 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 71 | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | United States | 63141 |
| 72 | Children's Mercy Hospitals and Clinics | Kansas City | Missouri | United States | 64108 |
| 73 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 74 | Siteman Cancer Center-South County | Saint Louis | Missouri | United States | 63129 |
| 75 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 76 | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri | United States | 63376 |
| 77 | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | United States | 68114 |
| 78 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 79 | Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas | Nevada | United States | 89135 |
| 80 | Renown Regional Medical Center | Reno | Nevada | United States | 89502 |
| 81 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 82 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 83 | Memorial Sloan Kettering Monmouth | Middletown | New Jersey | United States | 07748 |
| 84 | Memorial Sloan Kettering Bergen | Montvale | New Jersey | United States | 07645 |
| 85 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 86 | Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | United States | 08903 |
| 87 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 88 | Saint Joseph's Regional Medical Center | Paterson | New Jersey | United States | 07503 |
| 89 | Albany Medical Center | Albany | New York | United States | 12208 |
| 90 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 91 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 92 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 93 | The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | United States | 11040 |
| 94 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 95 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 96 | NYP/Weill Cornell Medical Center | New York | New York | United States | 10065 |
| 97 | University of Rochester | Rochester | New York | United States | 14642 |
| 98 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 99 | State University of New York Upstate Medical University | Syracuse | New York | United States | 13210 |
| 100 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
| 101 | New York Medical College | Valhalla | New York | United States | 10595 |
| 102 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 103 | East Carolina University | Greenville | North Carolina | United States | 27834 |
| 104 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
| 105 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 106 | Children's Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
| 107 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 108 | Rainbow Babies and Childrens Hospital | Cleveland | Ohio | United States | 44106 |
| 109 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 110 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 111 | Dayton Children's Hospital | Dayton | Ohio | United States | 45404 |
| 112 | ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | United States | 43606 |
| 113 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 114 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 115 | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | United States | 18103 |
| 116 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 117 | Penn State Children's Hospital | Hershey | Pennsylvania | United States | 17033 |
| 118 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 119 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
| 120 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
| 121 | Prisma Health Richland Hospital | Columbia | South Carolina | United States | 29203 |
| 122 | Saint Francis Hospital | Greenville | South Carolina | United States | 29601 |
| 123 | BI-LO Charities Children's Cancer Center | Greenville | South Carolina | United States | 29605 |
| 124 | Saint Francis Cancer Center | Greenville | South Carolina | United States | 29607 |
| 125 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 126 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 127 | East Tennessee Childrens Hospital | Knoxville | Tennessee | United States | 37916 |
| 128 | Saint Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
| 129 | The Children's Hospital at TriStar Centennial | Nashville | Tennessee | United States | 37203 |
| 130 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 131 | Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | United States | 79106 |
| 132 | Dell Children's Medical Center of Central Texas | Austin | Texas | United States | 78723 |
| 133 | Driscoll Children's Hospital | Corpus Christi | Texas | United States | 78411 |
| 134 | Medical City Dallas Hospital | Dallas | Texas | United States | 75230 |
| 135 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 136 | El Paso Children's Hospital | El Paso | Texas | United States | 79905 |
| 137 | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | United States | 77030 |
| 138 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 139 | Covenant Children's Hospital | Lubbock | Texas | United States | 79410 |
| 140 | UMC Cancer Center / UMC Health System | Lubbock | Texas | United States | 79415 |
| 141 | Children's Hospital of San Antonio | San Antonio | Texas | United States | 78207 |
| 142 | Methodist Children's Hospital of South Texas | San Antonio | Texas | United States | 78229 |
| 143 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 144 | Primary Children's Hospital | Salt Lake City | Utah | United States | 84113 |
| 145 | Inova Fairfax Hospital | Falls Church | Virginia | United States | 22042 |
| 146 | Children's Hospital of The King's Daughters | Norfolk | Virginia | United States | 23507 |
| 147 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 148 | Carilion Children's | Roanoke | Virginia | United States | 24014 |
| 149 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
| 150 | Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | United States | 99204 |
| 151 | Mary Bridge Children's Hospital and Health Center | Tacoma | Washington | United States | 98405 |
| 152 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431 |
| 153 | West Virginia University Charleston Division | Charleston | West Virginia | United States | 25304 |
| 154 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53792 |
| 155 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
| 156 | John Hunter Children's Hospital | Hunter Regional Mail Centre | New South Wales | Australia | 2310 |
| 157 | The Children's Hospital at Westmead | Westmead | New South Wales | Australia | 2145 |
| 158 | Queensland Children's Hospital | South Brisbane | Queensland | Australia | 4101 |
| 159 | Perth Children's Hospital | Perth | Western Australia | Australia | 6009 |
| 160 | University of Alberta Hospital | Edmonton | Alberta | Canada | T6G 2B7 |
| 161 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 162 | Janeway Child Health Centre | Saint John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 163 | IWK Health Centre | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 164 | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8N 3Z5 |
| 165 | Children's Hospital | London | Ontario | Canada | N6A 5W9 |
| 166 | Children's Hospital of Eastern Ontario | Ottawa | Ontario | Canada | K1H 8L1 |
| 167 | Hospital for Sick Children | Toronto | Ontario | Canada | M5G 1X8 |
| 168 | The Montreal Children's Hospital of the MUHC | Montreal | Quebec | Canada | H3H 1P3 |
| 169 | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 170 | Centre Hospitalier Universitaire de Quebec | Quebec | Canada | G1V 4G2 | |
| 171 | HIMA San Pablo Oncologic Hospital | Caguas | Puerto Rico | 00726 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Lisa G Roth, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2021-01071
- NCI-2021-01071
- ANHL1931
- ANHL1931
- U10CA180886