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Could a smart immune therapy beat chemo for relapsed childhood leukemia?

NCT ID NCT02101853

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study compares a targeted immune therapy called blinatumomab to standard chemotherapy in 669 children and young adults (ages 1-30) whose B-cell acute lymphoblastic leukemia has returned after initial treatment. The goal is to see if blinatumomab can keep the cancer away longer and improve survival. Participants are grouped by risk level and randomly assigned to receive either blinatumomab or additional chemo after an initial round of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

669 people

The number who actually took part.

Started

Dec 2014

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 31 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients \>= 1 year and \< 31 years of age at the time of relapse will be eligible * First relapse of B-ALL, allowable sites of disease include isolated bone marrow, combined bone marrow and CNS and/or testicular, and isolated CNS and/or testicular; extramedullary sites are limited to the CNS and testicles * No waiting period for patients who relapse while receiving standard maintenance therapy * Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy, or maintenance chemotherapy, or intrathecal chemotherapy (methotrexate strongly preferred) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status * Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur * Stem cell transplant or rescue: patient has not had a prior stem cell transplant or rescue * Patient has not had prior treatment with blinatumomab * With the exception of intrathecal chemotherapy (methotrexate strongly preferred; cytarabine is permissible) administered at the time of the required diagnostic lumbar puncture to establish baseline CNS status, patient has not received prior relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of first relapse) * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows: * 1 to \< 2 years: =\< 0.6 mg/dL * 2 to \< 6 years: =\< 0.8 mg/dL * 6 to \< 10 years: =\< 1 mg/dL * 10 to \< 13 years: =\< 1.2 mg/dL * 13 to \< 16 years: =\< 1.5 mg/dL (males) and =\< 1.4 mg/dL (females) * \>= 16 years: =\< 1.7 mg/dL (males) and =\< 1.4 mg/dL (females) * Direct bilirubin \< 3.0 mg/dL * Shortening fraction of \>= 27% by echocardiogram, or * Ejection fraction of \>= 50% by radionuclide angiogram * All patients and/or their parent or legal guardian 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: * Patients with Philadelphia chromosome positive/breakpoint cluster region protein (BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL are not eligible * Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible * Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not eligible * Patients with B-lymphoblastic lymphoma (B-LL) are not eligible * Patients with known optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to determine optic nerve or retinal involvement * Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome * Patients with known human immunodeficiency virus (HIV) infection * Patients with known allergy to mitoxantrone, cytarabine, or both etoposide and etoposide phosphate (Etopophos) * Lactating females who plan to breastfeed * 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 an effective contraceptive method for the duration of their study participation * Patients with pre-existing significant central nervous system pathology that would preclude treatment with blinatumomab, including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible; patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved) * Patients with uncontrolled seizure disorder are not eligible; (patients with seizure disorders that do not require antiepileptic drugs, or are well controlled with stable doses of antiepileptic drugs remain eligible)

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent B acute lymphoblastic leukemia

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois, 60453, United States

  • Advocate Children's Hospital-Park Ridge

    Park Ridge, Illinois, 60068, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada, 89135, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591, United States

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260, United States

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605, United States

  • Banner Children's at Desert

    Mesa, Arizona, 85202, United States

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719, United States

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030, United States

  • Baystate Medical Center

    Springfield, Massachusetts, 01199, United States

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4, Canada

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316, United States

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

    Québec, G1V 4G2, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Carilion Children's

    Roanoke, Virginia, 24014, United States

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    Atlanta, Georgia, 30329, United States

  • Children's Hospital

    London, Ontario, N6A 5W9, Canada

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308, United States

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska, 68114, United States

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233, United States

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of San Antonio

    San Antonio, Texas, 78207, United States

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507, United States

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Children's Hospitals and Clinics of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404, United States

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108, United States

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010, United States

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106, United States

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Corewell Health Children's

    Royal Oak, Michigan, 48073, United States

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503, United States

  • Covenant Children's Hospital

    Lubbock, Texas, 79410, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756, United States

  • Dayton Children's Hospital

    Dayton, Ohio, 45404, United States

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723, United States

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • East Tennessee Childrens Hospital

    Knoxville, Tennessee, 37916, United States

  • Eastern Maine Medical Center

    Bangor, Maine, 04401, United States

  • El Paso Children's Hospital

    El Paso, Texas, 79905, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908, United States

  • HIMA San Pablo Oncologic Hospital

    Caguas, 00726, Puerto Rico

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236, United States

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Hurley Medical Center

    Flint, Michigan, 48503, United States

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Janeway Child Health Centre

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242, United States

  • Kaiser Permanente-Oakland

    Oakland, California, 94611, United States

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826, United States

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016, United States

  • Legacy Emanuel Children's Hospital

    Portland, Oregon, 97227, United States

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017, United States

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103, United States

  • Loma Linda University Medical Center

    Loma Linda, California, 92354, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94304, United States

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611, United States

  • Madigan Army Medical Center

    Tacoma, Washington, 98431, United States

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074, United States

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449, United States

  • Mattel Children's Hospital UCLA

    Los Angeles, California, 90095, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5, Canada

  • Medical City Dallas Hospital

    Dallas, Texas, 75230, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021, United States

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141, United States

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229, United States

  • Michigan State University

    East Lansing, Michigan, 48823, United States

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California, 90806, United States

  • Mission Hospital

    Asheville, North Carolina, 28801, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Morristown Medical Center

    Morristown, New Jersey, 07960, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504, United States

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207, United States

  • New York Medical College

    Valhalla, New York, 10595, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • Norton Children's Hospital

    Louisville, Kentucky, 40202, United States

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204, United States

  • OSF Children's Hospital of Illinois

    Peoria, Illinois, 61637, United States

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Palms West Radiation Therapy

    Loxahatchee Groves, Florida, 33470, United States

  • Perth Children's Hospital

    Perth, Western Australia, 6009, Australia

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6008, Australia

  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

    Toledo, Ohio, 43606, United States

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508, United States

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204, United States

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123, United States

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

    Denver, Colorado, 80218, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903, United States

  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134, United States

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    Tampa, Florida, 33607, United States

  • Saint Joseph's Regional Medical Center

    Paterson, New Jersey, 07503, United States

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712, United States

  • Saint Mary's Medical Center

    West Palm Beach, Florida, 33407, United States

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301, United States

  • San Jorge Children's Hospital

    San Juan, 00912, Puerto Rico

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134, United States

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102, United States

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Scott and White Memorial Hospital

    Temple, Texas, 76508, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215, United States

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702, United States

  • Starship Children's Hospital

    Grafton, Auckland, 1145, New Zealand

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794, United States

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada, 89144, United States

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109, United States

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816, United States

  • T C Thompson Children's Hospital

    Chattanooga, Tennessee, 37403, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203, United States

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3, Canada

  • The Steven and Alexandra Cohen Children's Medical Center of New York

    New Hyde Park, New York, 11040, United States

  • Tufts Children's Hospital

    Boston, Massachusetts, 02111, United States

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610, United States

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • USA Health Strada Patient Care Center

    Mobile, Alabama, 36604, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390, United States

  • University Pediatric Hospital

    San Juan, 00926, Puerto Rico

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136, United States

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908, United States

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298, United States

  • Valley Children's Hospital

    Madera, California, 93636, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • West Virginia University Charleston Division

    Charleston, West Virginia, 25304, United States

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

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