Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia

NCT02143414 | Active Not Recruiting Phase 2 Results

• 4 other identifiers: NCI-2014-01047SWOG-S1318S1318U10CA180888
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 196

Brief Summary

This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, 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. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.

Conditions

Refractory Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia; Recurrent Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Overall Survival Rate (Cohort I)

  To evaluate the 3-year overall survival rate in elderly participants with newly diagnosed Ph-negative ALL treated with blinatumomab followed by POMP maintenance. Overall

  From the day of registration on study until death from any cause, assessed at 3 years

• Incidence of Dose-limiting Toxicity (Cohort II)

  Defined as any grade 4 or higher treatment-related, non-hematologic toxicity in the first cycle of post-remission therapy (blinatumomab/dasatinib) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only participants with Ph-positive ALL or Ph-like DSMKF ALL were evaluated.

  Up to day 42 of post-remission therapy

Secondary Outcomes (7)

• Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs

  Duration of treatment and follow up until death or date of primary analysis (about 7.5 years)

• Complete Response Rate (Cohort I)

  Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)

• Disease-free Survival (Cohort II)

  Duration of treatment and follow up until death or date of primary analysis (about 7.5 years)

• Overall Survival (Cohort II)

  Up to 10 years

• Minimal Residual Disease Negativity

  Participants are assessed after induction treatment and again after re-induction treatment, if re-induction treatment is received (i.e. up to 85 days after registration)

Study Arms (2)

Cohort I (blinatumomab, POMP)

EXPERIMENTAL

See Detailed Description

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Methotrexate Sodium; Drug: Prednisone; Drug: Vincristine; Drug: Vincristine Sulfate; Procedure: X-Ray Imaging

Cohort II (dasatinib, prednisone, blinatumomab)

EXPERIMENTAL

See Detailed Description

Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Biological: Blinatumomab; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Computed Tomography; Drug: Dasatinib; Procedure: Echocardiography Test; Procedure: Lumbar Puncture; Procedure: Magnetic Resonance Imaging; Drug: Prednisone; Procedure: X-Ray Imaging

Interventions

Bone Marrow Aspiration and Biopsy PROCEDURE

Undergo a bone marrow aspiration and biopsy

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Biopsy Procedure PROCEDURE

Undergo a biopsy

Also known as: Biopsy, BIOPSY_TYPE, Bx

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Computed Tomography PROCEDURE

Undergo a CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Mercaptopurine DRUG

Given PO

Also known as: 3H-Purine-6-thiol, 6 MP, 6 Thiohypoxanthine, 6 Thiopurine, 6-Mercaptopurine, 6-Mercaptopurine Monohydrate, 6-MP, 6-Purinethiol, 6-Thiopurine, 6-Thioxopurine, 6H-Purine-6-thione, 1,7-dihydro- (9CI), 7-Mercapto-1,3,4,6-tetrazaindene, Alti-Mercaptopurine, Azathiopurine, Bw 57-323H, Flocofil, Ismipur, Leukerin, Leupurin, Mercaleukim, Mercaleukin, Mercaptina, Mercaptopurinum, Mercapurin, Mern, NCI-C04886, Puri-Nethol, Purimethol, Purine, 6-mercapto-, Purine-6-thiol (8CI), Purine-6-thiol, monohydrate, Purinethiol, Purinethol, U-4748, WR-2785

Cohort I (blinatumomab, POMP)

Methotrexate DRUG

Given PO

Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039

Cohort I (blinatumomab, POMP)

Methotrexate Sodium DRUG

Given PO

Also known as: Sodium Methotrexate, Trexall, Xatmep

Cohort I (blinatumomab, POMP)

Prednisone DRUG

Given PO

Also known as: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Blinatumomab BIOLOGICAL

Given IV

Also known as: AMG 103, AMG-103, AMG103, Anti-CD19 x Anti-CD3 Bispecific Monoclonal Antibody, Anti-CD19/Anti-CD3 Recombinant Bispecific Monoclonal Antibody MT103, Blincyto, MEDI 538, MEDI-538, MEDI538, MT 103, MT-103, MT103

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Dasatinib DRUG

Given PO

Also known as: BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel

Cohort II (dasatinib, prednisone, blinatumomab)

Lumbar Puncture PROCEDURE

Undergo a lumbar puncture

Also known as: LP, Spinal Tap

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Vincristine DRUG

Given IV

Also known as: LCR, Leurocristine, VCR, Vincrystine

Cohort I (blinatumomab, POMP)

Vincristine Sulfate DRUG

Given IV

Also known as: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate

Cohort I (blinatumomab, POMP)

X-Ray Imaging PROCEDURE

Undergo an x-ray

Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiographic imaging procedure (procedure), Radiography, RG, Static X-Ray, X-Ray

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Biospecimen Collection PROCEDURE

Undergo a blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Echocardiography Test PROCEDURE

Undergo ECHO

Also known as: EC, Echocardiography

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Cohort I (blinatumomab, POMP); Cohort II (dasatinib, prednisone, blinatumomab)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Registration Step 1 - Induction/Re-Induction:
• Patients must have a new morphologic diagnosis of precursor B cell acute lymphoblastic leukemia (ALL) (non T cell) based on World Health Organization (WHO) criteria; patients with Burkitt's (L3) are excluded; patients with Ph-positive or Ph-like ALL with dasatinib-sensitive mutations or kinase fusions may have relapsed or refractory diagnoses
• NOTE: Relapsed/refractory Ph-positive patients or Ph-like patients with dasatinib-sensitive mutations or kinase fusions who have previous exposure to either dasatinib or another 2nd or 3rd generation tyrosine kinase inhibitor (TKI) will begin protocol therapy with Cohort 2: re-induction cycle 1
• Patients must have a diagnosis of Philadelphia chromosome negative ALL or Ph chromosome positive ALL by cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR); patients will be registered to receive treatment in either Cohort 1 (Ph-) or Cohort 2 (Ph+ or Ph-like DSMKF) based on these results; diagnostic specimens must be submitted to the site's local Clinical Laboratory Improvement Amendments (CLIA)-approved cytogenetics laboratory and results of tests (cytogenetics, FISH or PCR) must confirm Ph status prior to registration; if not already known, breakpoint cluster region- abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) status (p190 or p210) must be evaluated in Ph-positive patients by PCR
• For Cohort 2, Ph-like testing is not required specifically for this study; however, to be registered to Cohort 2 under the Ph-like DSMKF criterion, the patient must have a known or presumed activating Ph-like signature and dasatinib-sensitive mutation or kinase fusion, such as: ABL1, ABL2, colony stimulating factor 1 receptor (CSF1R), platelet derived growth factor receptor beta (PDGFRB), platelet derived growth factor receptor alpha (PDGFRA), or fibroblast growth factor receptor (FGFR)s that was otherwise identified as part of normal standard of care; prior to registering any patients with a known or presumed activating Ph-like signature and dasatinib-sensitive mutations or kinase fusions (DSMKF) treating physicians must confirm eligibility with the study chairs via email; the study chairs must respond via email with confirmation of patient eligibility prior to patient registration
• All newly diagnosed patients must have evidence of ALL in their marrow or peripheral blood with at least 20% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration; all relapsed/refractory patients (Cohort 2) must have at least 5% lymphoblasts present in blood or bone marrow collected within 28 days prior to registration; for relapsed/refractory patients, pathology and cytogenetics reports (both from time of original diagnosis) must be submitted at time of registration; if a bone marrow aspirate cannot be obtained despite an attempt (dry tap), appropriate immunohistochemistry (IHC) testing, including cluster of differentiation (CD)19, must be performed on the bone marrow biopsy to determine lineage; for ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T cell or mixed B/T cell); appropriate marker studies including CD19 (B cell), must be performed; co-expression of myeloid antigens (CD13 and CD33) will not exclude patients; if possible, the lineage specific markers (myeloid cells) should be determined; the blood/bone marrow sample for these assays must be obtained within 28 days prior to registration; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible
• Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, active ALL in the CNS confirmed by cerebrospinal fluid (CSF) analysis, or other significant CNS abnormalities
• Patients must have a lumbar puncture to determine CNS involvement of ALL within 14 days prior to registration; patients with CNS3 are excluded from the trial; patients with CNS1 or CNS2 will be eligible, but will be monitored for CNS involvement; note that intrathecal methotrexate administered during the pre-study lumbar puncture may count as the first dose of intrathecal therapy required as part of the study
• Cohort I, Ph-negative Patients Only: Patients must not have received any prior chemotherapy, radiation therapy, or other therapy for the treatment of ALL (other than those noted below) and must not be receiving any immunosuppressive therapy; patients may not have received any prior investigational therapy within 28 days prior to registration; patients must not have received any monoclonal antibody therapy within 42 days of registration; patients may have received the following within any time prior to registration: low dose chemotherapy-including: cyclophosphamide 1 g/m\^2, oral 6-mercaptopurine, or oral methotrexate (other low dose chemotherapy may be allowable, however any other options not listed here should be confirmed with the study chairs), TKI therapy, steroids, hydroxyurea, leukapheresis, intrathecal chemotherapy or vincristine
• Cohort I, Ph-negative Patients Only: In the event that the patient's bone marrow blast count is \>= 50% blasts, patients may be registered but should receive steroids for 3-5 days in order to reduce tumor burden prior to blinatumomab administration, as follows
• Prephase treatment with dexamethasone (10-20 mg/m\^2) for 3-5 days is required for patients with bone marrow blasts \>= 50%, peripheral blood blasts 15,000/uL or higher, or elevated lactate dehydrogenase (LDH) suggesting rapidly progressive disease per investigator opinion
• Pre-treatment should conclude at least 24 hours prior to the first dose of blinatumomab (although additional dexamethasone is automatically given as a pre-med prior to the first dose); at the time of first infusion of blinatumomab, the absolute peripheral blast count should be \< 25,000/uL
• Note: For the purposes of the study, day 1 of the cycle will be the first day of blinatumomab administration
• Cohort I, Ph-negative Patients Only: It is preferred, but not required, that corticosteroids and hydroxyurea should start only after all diagnostic samples have been obtained; however, if the patient was previously on corticosteroids and/or hydroxyurea, this is allowable provided that the patient still has measurable disease at time of the bone marrow aspirate
• Corticosteroids and/or hydroxyurea, as well as any of the other therapies mentioned (with the exception of IV cyclophosphamide), may continue to be administered, at physician discretion, until 1 day prior to blinatumomab administration

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (196)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

Location

John L McClellan Memorial Veterans Hospital

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States

Location

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Rush-Copley Medical Center

Aurora, Illinois, 60504, United States

Location

OSF Saint Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States

Location

Illinois CancerCare-Canton

Canton, Illinois, 61520, United States

Location

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902, United States

Location

Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States

Location

Centralia Oncology Clinic

Centralia, Illinois, 62801, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Carle at The Riverfront

Danville, Illinois, 61832, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States

Location

Crossroads Cancer Center

Effingham, Illinois, 62401, United States

Location

Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States

Location

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States

Location

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401, United States

Location

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States

Location

Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States

Location

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States

Location

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States

Location

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States

Location

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States

Location

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States

Location

Radiation Oncology of Northern Illinois

Ottawa, Illinois, 61350, United States

Location

Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States

Location

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554, United States

Location

Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States

Location

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois CancerCare-Peru

Peru, Illinois, 61354, United States

Location

Valley Radiation Oncology

Peru, Illinois, 61354, United States

Location

Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62702, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Springfield Clinic

Springfield, Illinois, 62702, United States

Location

Springfield Memorial Hospital

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

The Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560, United States

Location

Franciscan Health Indianapolis

Indianapolis, Indiana, 46237, United States

Location

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, 46360, United States

Location

Woodland Cancer Care Center

Michigan City, Indiana, 46360, United States

Location

Reid Health

Richmond, Indiana, 47374, United States

Location

McFarland Clinic - Ames

Ames, Iowa, 50010, United States

Location

McFarland Clinic - Boone

Boone, Iowa, 50036, United States

Location

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501, United States

Location

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129, United States

Location

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158, United States

Location

Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States

Location

Cancer Center of Kansas - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

Cancer Center of Kansas-Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas-Liberal

Liberal, Kansas, 67905, United States

Location

Cancer Center of Kansas - McPherson

McPherson, Kansas, 67460, United States

Location

Cancer Center of Kansas - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas - Salina

Salina, Kansas, 67401, United States

Location

Cancer Center of Kansas - Wellington

Wellington, Kansas, 67152, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

Associates In Womens Health

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas - Winfield

Winfield, Kansas, 67156, United States

Location

Oncology Hematology Care Inc-Crestview

Crestview Hills, Kentucky, 41017, United States

Location

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States

Location

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Hickman Cancer Center

Adrian, Michigan, 49221, United States

Location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

Location

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, 48336, United States

Location

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503, United States

Location

William Beaumont Hospital-Grosse Pointe

Grosse Pointe, Michigan, 48230, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Beacon Kalamazoo

Kalamazoo, Michigan, 49048, United States

Location

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, 48162, United States

Location

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444, United States

Location

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120, United States

Location

Corewell Health Reed City Hospital

Reed City, Michigan, 49677, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085, United States

Location

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States

Location

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613, United States

Location

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, 63628, United States

Location

Cox Cancer Center Branson

Branson, Missouri, 65616, United States

Location

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Mercy Hospital Joplin

Joplin, Missouri, 64804, United States

Location

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States

Location

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States

Location

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127, United States

Location

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123, United States

Location

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

ECU Health Oncology Kenansville

Kenansville, North Carolina, 28349, United States

Location

ECU Health Oncology Kinston

Kinston, North Carolina, 28501, United States

Location

ECU Health Oncology Richlands

Richlands, North Carolina, 28574, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States

Location

Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States

Location

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

Location

Oncology Hematology Care Inc-Eden Park

Cincinnati, Ohio, 45202, United States

Location

Oncology Hematology Care Inc-Mercy West

Cincinnati, Ohio, 45211, United States

Location

Oncology Hematology Care Inc-Anderson

Cincinnati, Ohio, 45230, United States

Location

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, 45236, United States

Location

Oncology Hematology Care Inc-Blue Ash

Cincinnati, Ohio, 45242, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Miami Valley Hospital North

Dayton, Ohio, 45415, United States

Location

Oncology Hematology Care Inc-Healthplex

Fairfield, Ohio, 45014, United States

Location

Blanchard Valley Hospital

Findlay, Ohio, 45840, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, 43537, United States

Location

Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

Maumee, Ohio, 43537, United States

Location

Saint Charles Hospital

Oregon, Ohio, 43616, United States

Location

Springfield Regional Cancer Center

Springfield, Ohio, 45504, United States

Location

Springfield Regional Medical Center

Springfield, Ohio, 45504, United States

Location

Mercy Health - Saint Anne Hospital

Toledo, Ohio, 43623, United States

Location

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, 43623, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

Wright-Patterson Medical Center

Wright-Patterson Air Force Base, Ohio, 45433, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States

Location

Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States

Location

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, 29601, United States

Location

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States

Location

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States

Location

Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States

Location

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Advani AS, Moseley A, O'Dwyer KM, Wood BL, Park J, Wieduwilt M, Jeyakumar D, Yaghmour G, Atallah EL, Gerds AT, O'Brien SM, Liesveld JL, Othus M, Litzow M, Stone RM, Sharon E, Erba HP. Dasatinib/prednisone induction followed by blinatumomab/dasatinib in Ph+ acute lymphoblastic leukemia. Blood Adv. 2023 Apr 11;7(7):1279-1285. doi: 10.1182/bloodadvances.2022008216.

  PMID: 36322825 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma

Interventions

Biopsy; Specimen Handling; blinatumomab; N,N-dicyclohexyl-isoborneol-10-sulfonamide; Dasatinib; Spinal Puncture; Magnetic Resonance Spectroscopy; Mercaptopurine; azathiopurine; Methotrexate; merphos; Prednisone; deltacortene; prednylidene; Vincristine; X-Rays; Phantoms, Imaging

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Sulfhydryl Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Equipment and Supplies

Results Point of Contact

• Title: Leukemia Committee Statistician
• Organization: SWOG Statistics and Data Management Center

amoseley@fredhutch.org

2066674623

Study Officials

• Anjali S Advani

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: June 30, 2015
• Primary Completion: June 1, 2022
• Study Completion (Estimated): January 26, 2027
• Last Updated: April 13, 2026
• Results First Posted: January 25, 2023

Record last verified: 2026-02

Locations

US (196)