Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia
NCT ID: NCT03150693
Last Updated: 2025-09-05
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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SUSPENDED
PHASE3
310 participants
INTERVENTIONAL
2017-09-20
2026-08-31
Brief Summary
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Detailed Description
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I. To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403.
II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III)
SECONDARY OBJECTIVES:
I. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response.
II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, with censoring for transplant.
III. To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.
IV. To determine the prognosis based on patients' low-density array (LDA) gene signature in terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to the C10403 backbone regimen.
V. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403.
TERTIARY OBJECTIVES:
I. To assess both the correlation of MRD post-induction and at sequential timepoints with LDA signature.
II. To evaluate the influence of MRD status (detectable vs. not and as a continuous measure) in relation to EFS both in the univariate setting as well as adjusting for other clinical features including initial white blood cell (WBC), ethnicity, gender and age at diagnosis.
III. To evaluate the impact of inotuzumab ozogamicin (inotuzumab) on the kinetics of MRD during treatment with inotuzumab in patients randomized to the experimental treatment arm.
IV. To perform genomic analyses to identify and evaluate the incidence and clinical significance of recurring novel fusion genes including those associated with the BCR-ABL1-like signature and to correlate with MRD status, CR rate, EFS and OS.
V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population.
VI. To assess the incidence of inherited genetic variants in the GR1A1, CEP72, CPA2, TPMT, NUDT15, GRIN3A, GRIK1, and other genes (which can be found using a whole genome association study \[GWAS\]), are correlated with increased rates of target toxicities including peripheral neuropathy, hepatotoxicity, pancreatitis, myelosuppression, neurotoxicity, thrombosis, and osteonecrosis, and correlate with treatment discontinuation and other clinical response parameters including complete response (CR) rate, EFS, and OS.
VII. To evaluate asparaginase pharmacokinetics in adolescents and young adults, and investigate its correlation with toxicities and treatment outcomes.
VIII. To investigate the effect of anti-polyethylene glycol (PEG) and anti-agouti signaling protein (ASP) antibodies (PEG-ASP) on ASP enzyme activity.
IX. To measure adherence to oral 6 mercaptopurine (MP) and methotrexate in AYAs with acute lymphoblastic leukemia (ALL) and to examine sociodemographic and behavioral determinants of adherence.
X. To determine the impact of adherence on risk of relapse among AYAs with ALL.
OUTLINE:
COURSE I (REMISSION INDUCTION THERAPY): All patients receive allopurinol orally (PO) once daily until peripheral blasts and extramedullary disease are reduced and cytarabine intrathecally (IT) over 1 minute on day 1. Patients also receive daunorubicin hydrochloride intravenously (IV) and vincristine sulfate IV on days 1, 8, 15 and 22, dexamethasone PO or IV twice daily (BID) on days 1-7 and 15-21, pegylated L-aspiraginase IV on day 4, 5, or 6, and methotrexate IT over 1 minute on days 8 and 29. Patients with central nervous system (CNS) 3 disease receive methotrexate IT over 1 minute also on days 15 and 22. All patients then undergo bone marrow aspirate and biopsy on day 29.
Patients with response to remission induction therapy are randomized to 1 of 2 arms. Patients with no response are omitted from the study.
ARM I:
COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV on days 15, 22, 43, and 50. Patients also receive pegylated L-aspiraginase IV on days 15 and 43, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20 positive (+) patients receive rituximab IV on days 1, 8, 29, and 36. Patients then undergo bone marrow aspirate and biopsy on day 56.
COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV on days 1, 11, 21, 31, and 41, methotrexate IV and IT on days 1, 11, 21, 31, and 41, and pegylated L-aspiraginase IV on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11.
COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV on days 1, 8, and 15, and pegylated L-aspiraginase IV on day 4, 5, or 6 and day 43. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy on day 50.
COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT or PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I.
After completion of study treatment, patients are followed up every month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months for the fourth through tenth year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (frontline chemotherapy)
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Allopurinol
Given PO
Cytarabine
Given IT, IV, SC
Daunorubicin Hydrochloride
Given IV
Vincristine Sulfate
Given IV
Dexamethasone
Given PO or IV
Pegylated L-Asparaginase
Given IV
Methotrexate
Given IT, IV, PO
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Cyclophosphamide
Given IV
Mercaptopurine
Given PO
Rituximab
Given IV
Thioguanine
Given PO
Laboratory Biomarker Analysis
Correlative studies
Arm II (frontline chemotherapy, inotuzumab ozogamicin)
Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I.
Allopurinol
Given PO
Cytarabine
Given IT, IV, SC
Daunorubicin Hydrochloride
Given IV
Vincristine Sulfate
Given IV
Dexamethasone
Given PO or IV
Pegylated L-Asparaginase
Given IV
Methotrexate
Given IT, IV, PO
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Cyclophosphamide
Given IV
Mercaptopurine
Given PO
Rituximab
Given IV
Doxorubicin
Given IV
Thioguanine
Given PO
Inotuzumab Ozogamicin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Allopurinol
Given PO
Cytarabine
Given IT, IV, SC
Daunorubicin Hydrochloride
Given IV
Vincristine Sulfate
Given IV
Dexamethasone
Given PO or IV
Pegylated L-Asparaginase
Given IV
Methotrexate
Given IT, IV, PO
Bone Marrow Aspiration and Biopsy
Undergo bone marrow aspiration and biopsy
Cyclophosphamide
Given IV
Mercaptopurine
Given PO
Rituximab
Given IV
Doxorubicin
Given IV
Thioguanine
Given PO
Inotuzumab Ozogamicin
Given IV
Laboratory Biomarker Analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible
* Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: flow cytometry is to be performed at the local reference lab and must include assessment of CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity
* No prior therapy except for limited treatment (\< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine
* No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC
* Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; systemic chemotherapy must begin within 72 hours of this intrathecal therapy
* Patients receiving prior steroid therapy are eligible for study; the dose and duration of previous steroid therapy should be carefully documented on case report forms
* Not pregnant and not nursing; for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patients with down syndrome are excluded from this study
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
* Direct bilirubin =\< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver
* Calculated (calc.) creatinine clearance \>= 50 mL/min by Cockcroft-Gault
RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)
* Completion of remission induction therapy
* Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized
* Rating: M0, M1; Blast Cells (%): 0-5.0
* Rating: M2; Blast Cells (%): 5.1-25.0
* Rating: M3; Blast Cells (%): \> 25-50
* Rating: M4; Blast Cells (%): \> 50.0
* The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells
* No ascites, effusions or significant edema
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Total bilirubin =\< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome
* Aspartate aminotransferase (AST) =\< 8 x upper limit of normal (ULN)
* Completion of first 12 weeks (12+ weeks) of maintenance therapy (Course V)
* Patient has at least 24 weeks (24+ weeks) remaining before end of maintenance therapy (Course V)
* Patient is in complete continuous first remission at entry into A041501-HO1
* Patient is receiving oral anti-metabolite chemotherapy during the maintenance phase of therapy; treatment plan must call for the following doses of antimetabolites: 6MP 75 mg/m2/day orally; methotrexate (MTX) 20 mg/m2/week orally (modification of 6 MP or MTX dosing based on laboratory or clinical parameters is acceptable)
* Patient is able and willing to use the Medication Event Monitoring System (MEMS) TrackCap (e.g. not using a pillbox)
18 Years
39 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States
PCR Oncology
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Community Cancer Institute
Clovis, California, United States
University Oncology Associates
Clovis, California, United States
UC Irvine Health Cancer Center-Newport
Costa Mesa, California, United States
Kaiser Permanente Dublin
Dublin, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Fresno Cancer Center
Fresno, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, United States
Kaiser Permanente-Redwood City
Redwood City, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
Rohnert Park Cancer Center
Rohnert Park, California, United States
Kaiser Permanente-Roseville
Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, United States
Kaiser Permanente Downtown Commons
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente-South Sacramento
Sacramento, California, United States
South Sacramento Cancer Center
Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States
Kaiser Permanente San Leandro
San Leandro, California, United States
Kaiser Permanente-San Rafael
San Rafael, California, United States
Kaiser San Rafael-Gallinas
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, United States
National Jewish Health-Main Campus
Denver, Colorado, United States
The Women's Imaging Center
Denver, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western Surgical Care
Denver, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Banner McKee Medical Center
Loveland, Colorado, United States
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Augusta University Medical Center
Augusta, Georgia, United States
Island Urology-Hilo
Hilo, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Island Urology
Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, United States
Kuakini Medical Center
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
Emmett, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Loyola Medicine Homer Glen
Homer Glen, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Rush Cancer Care in Lisle
Lisle, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Saint Anthony Regional Hospital
Carroll, Iowa, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
Broadlawns Medical Center
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States
Medical Center of Baton Rouge
Baton Rouge, Louisiana, United States
Ochsner High Grove
Baton Rouge, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Caro Cancer Center
Caro, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
Henry Ford River District Hospital
East China Township, Michigan, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, United States
Henry Ford Saint John Hospital - Breast
Grosse Pointe Woods, Michigan, United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, United States
Beacon Kalamazoo
Kalamazoo, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Hope Cancer Clinic
Livonia, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, United States
Henry Ford Warren Hospital - Breast Macomb
Macomb, Michigan, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States
Hope Cancer Center
Pontiac, Michigan, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Corewell Health Reed City Hospital
Reed City, Michigan, United States
Henry Ford Rochester Hospital
Rochester Hills, Michigan, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Advanced Breast Care Center PLLC
Warren, Michigan, United States
Henry Ford Health Warren Hospital
Warren, Michigan, United States
Henry Ford Madison Heights Hospital - Breast
Warren, Michigan, United States
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, United States
Macomb Hematology Oncology PC
Warren, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, United States
University of Michigan Health - West
Wyoming, Michigan, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Riverwood Healthcare Center
Aitkin, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States
Cambridge Medical Center
Cambridge, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States
Essentia Health - Fosston
Fosston, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
Monticello Cancer Center
Monticello, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Cox Cancer Center Branson
Branson, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Center
Missoula, Montana, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, United States
GenesisCare USA - Henderson
Henderson, Nevada, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pebble
Henderson, Nevada, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, United States
Desert West Surgery
Las Vegas, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, United States
GenesisCare USA - Las Vegas
Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, United States
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
GenesisCare USA - Fort Apache
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
University Cancer Center
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Saint Mary's Regional Medical Center
Reno, Nevada, United States
Radiation Oncology Associates
Reno, Nevada, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Mount Sinai Hospital
New York, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Upstate Cancer Center at Verona
Verona, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Saint Charles Health System-Redmond
Redmond, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Miriam Hospital
Providence, Rhode Island, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
Covenant Medical Center-Lakeside
Lubbock, Texas, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States
Logan Regional Hospital
Logan, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Riverton Hospital
Riverton, Utah, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Saint George Regional Medical Center
St. George, Utah, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
Overlake Medical Center
Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Jefferson Healthcare
Port Townsend, Washington, United States
Valley Medical Center
Renton, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
Duluth Clinic Ashland
Ashland, Wisconsin, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
QEII Health Sciences Centre/Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Countries
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References
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Seftel MD. Hyper-CVAD: a regimen for all seasons. Lancet Haematol. 2020 Jul;7(7):e501-e502. doi: 10.1016/S2352-3026(20)30179-4. No abstract available.
Other Identifiers
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NCI-2016-01981
Identifier Type: REGISTRY
Identifier Source: secondary_id
A041501
Identifier Type: -
Identifier Source: org_study_id
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