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Spots Global Cancer Trial Database for Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

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Trial Identification

Brief Title: Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia

Official Title: Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Study ID: NCT02101853

Study Description

Brief Summary: This randomized phase III trial studies how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Immunotherapy with blinatumomab may allow the body's immune system to attack and destroy some types of leukemia cells. It is not yet known whether blinatumomab is more effective than standard combination chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia.

Detailed Description: PRIMARY OBJECTIVES: I. To compare disease free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapse B-cell acute lymphoblastic leukemia (B-ALL) patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization) as a part of a treatment regimen prior to allogeneic bone marrow transplantation. (Closed to enrollment effective September 18, 2019) II. To compare the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization). (Closed to enrollment effective September 30, 2019) SECONDARY OBJECTIVES: I. To compare overall survival (OS) of HR and IR relapse B-ALL patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization). (Closed to enrollment effective September 18, 2019) II. To compare OS of LR relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization). EXPLORATORY OBJECTIVES: I. To compare the rates of minimal residual disease (MRD) \>= 0.01% at the end of block 2 and block 3 for HR and IR relapse B-ALL patients in HR/IR randomization. II. To estimate, for treatment failure (TF) patients not previously receiving blinatumomab, the hematologic complete remission rate (CR), rate of MRD \< 0.01%, and proportion able to proceed to hematopoietic stem cell transplant (HSCT) in CR after treatment with blinatumomab. III. To assess the feasibility and safety of rapid taper of immune suppression for the subset of HSCT patients with MRD \>= 0.01% pre- and/or post-HSCT with no acute graft versus host disease (aGVHD). IV. To evaluate blinatumomab pharmacokinetics (PK) and explore exposure-response relationships for measures of safety and effectiveness. OUTLINE: All patients receive Block 1 over 4 weeks. BLOCK 1: Patients receive dexamethasone orally (PO) twice daily (BID) or intravenously (IV) on days 1-5 and 15-19; vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22; pegaspargase IV over 1-2 hours on days 3 and 17; mitoxantrone hydrochloride IV over 15-30 minutes on days 1-2, and methotrexate intrathecally (IT) on day 1. Patients with central nervous system (CNS) 1 or CNS2 also receive methotrexate IT on day 8. Patients with CNS3 (including isolated CNS relapse) also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8, 15, and 22. High risk and intermediate risk patients are then assigned to randomization R1. Low risk patients are assigned to randomization R2. RANDOMIZATION R1 (HR and IR patients): Patients are randomized to 1 of 2 treatment arms. Effective 09/18/2019, HR/IR patients not yet randomized are not eligible for post-Induction therapy on AALL1331 and will be removed from protocol therapy. Patients receiving therapy on Arm A prior to Amendment #10A who have not yet received day 22 treatment on Block 3 will be offered the opportunity to cross over to Arm B to receive blinatumomab. ARM A: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the Block 2. ARM B: Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the first block of blinatumomab. RANDOMIZATION R2 (LR patients): LR patients are randomized to 1 of 2 treatment arms. ARM C: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance. CNS3 patients receive chemoradiation post-Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2. ARM D: Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance. CNS3 patients receive chemoradiation post Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2. BLOCK 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; methotrexate IV over 36 hours on day 8; leucovorin calcium IV or PO on days 10-11; pegaspargase IV over 1-2 hours on day 9 or 10; cyclophosphamide IV over 15-30 minutes on days 15-19; and etoposide IV over 1-2 hours on days 15-19. Patients with CNS1 or CNS2 also receive methotrexate IT on day 8. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8 and 22. BLOCK 3: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9; asparaginase intramuscularly (IM) or IV over 1 hour on days 2, 4, 9, 11, and 23; methotrexate IT on day 1and IV over 36 hours on day 22; leucovorin calcium PO or IV on days 24-25. Patients with CNS1 or CNS2 also receive methotrexate IT on day 22. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 22. BLINATUMOMAB BLOCK 1: Patients receive dexamethasone PO or IV on day 1 and blinatumomab IV continuously on days 1-28. Patients with CNS1 or CNS2 also receive methotrexate IT on days 15 and 29. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 15 and 29. BLINATUMOMAB BLOCK 2: Patients receive blinatumomab IV continuously on days 1-28. Patients with CNS1 or CNS2 also receive methotrexate IT on days 8 and 29. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8 and 29. BLINATUMOMAB BLOCK 3: Patients receive blinatumomab IV continuously on days 1-28 and dexamethasone PO or IV on day 1. CONTINUATION 1 \& 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over 1 minute on day 1; mercaptopurine tablet PO on days 1-42; methotrexate PO on days 8, 15, 29, and 36; or; cyclophosphamide IV over 15-30 minutes on days 43 and 50; etoposide IV over 1-2 hours on days 43 and 50; thioguanine PO once daily on days 43-49; and cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 44-47 and 51-54. Patients with CNS1 or CNS2 also receive methotrexate IT on days 1 and 43, methotrexate PO every 6 hours for 4 doses on day 22, leucovorin calcium PO every 6 hours for 2 doses on day 24. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1 and 43 ; methotrexate IV over 36 hours on day 22; and leucovorin calcium IV or PO every 6 hours on days 24-25. MAINTENANCE: Patients receive dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61; vincristine sulfate IV over 1 minute on days 1, 29, and 57; mercaptopurine tablet PO on days 1-84; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Patients with CNS1 or CNS2 also receive methotrexate IT on day 1. Patients with CNS3 receive Triple Intrathecal Therapy (ITT) on day 1. Cycles repeat every 12 weeks for up to 2 years from the beginning of treatment in the absence of disease progression or unacceptable toxicity. MAINTENANCE CHEMORADIATION (LR CNS3 PATIENTS ONLY): Following maintenance cycle 1, patients receive 1800 cGy cranial radiation; dexamethasone PO BID or IV on days 1-7 and 15-21; vincristine sulfate IV over 1 minute on days 1, 8 and 15; and pegaspargase IV over 1-2 hours on day 1. Patients then resume maintenance with cycle 2 and beyond. After completion of study treatment, patients are followed up annually for 10 years.

Keywords

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Children's Hospital of Alabama, Birmingham, Alabama, United States

USA Health Strada Patient Care Center, Mobile, Alabama, United States

Providence Alaska Medical Center, Anchorage, Alaska, United States

Banner Children's at Desert, Mesa, Arizona, United States

Phoenix Childrens Hospital, Phoenix, Arizona, United States

Banner University Medical Center - Tucson, Tucson, Arizona, United States

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Kaiser Permanente Downey Medical Center, Downey, California, United States

City of Hope Comprehensive Cancer Center, Duarte, California, United States

Loma Linda University Medical Center, Loma Linda, California, United States

Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Cedars Sinai Medical Center, Los Angeles, California, United States

Mattel Children's Hospital UCLA, Los Angeles, California, United States

Valley Children's Hospital, Madera, California, United States

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States

Kaiser Permanente-Oakland, Oakland, California, United States

Children's Hospital of Orange County, Orange, California, United States

Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States

Sutter Medical Center Sacramento, Sacramento, California, United States

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Rady Children's Hospital - San Diego, San Diego, California, United States

UCSF Medical Center-Mission Bay, San Francisco, California, United States

Santa Barbara Cottage Hospital, Santa Barbara, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States

Children's Hospital Colorado, Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center, Denver, Colorado, United States

Connecticut Children's Medical Center, Hartford, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Alfred I duPont Hospital for Children, Wilmington, Delaware, United States

Children's National Medical Center, Washington, District of Columbia, United States

Broward Health Medical Center, Fort Lauderdale, Florida, United States

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States

University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States

Palms West Radiation Therapy, Loxahatchee Groves, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States

AdventHealth Orlando, Orlando, Florida, United States

Arnold Palmer Hospital for Children, Orlando, Florida, United States

Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States

Tampa General Hospital, Tampa, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States

Saint Mary's Hospital, West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States

Memorial Health University Medical Center, Savannah, Georgia, United States

Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States

Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States

Lurie Children's Hospital-Chicago, Chicago, Illinois, United States

University of Illinois, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Loyola University Medical Center, Maywood, Illinois, United States

Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois, United States

Advocate Children's Hospital-Park Ridge, Park Ridge, Illinois, United States

Saint Jude Midwest Affiliate, Peoria, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Riley Hospital for Children, Indianapolis, Indiana, United States

Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, United States

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Norton Children's Hospital, Louisville, Kentucky, United States

Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States

Eastern Maine Medical Center, Bangor, Maine, United States

Maine Children's Cancer Program, Scarborough, Maine, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Sinai Hospital of Baltimore, Baltimore, Maryland, United States

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

Walter Reed National Military Medical Center, Bethesda, Maryland, United States

Tufts Children's Hospital, Boston, Massachusetts, United States

Baystate Medical Center, Springfield, Massachusetts, United States

UMass Memorial Medical Center - University Campus, Worcester, Massachusetts, United States

C S Mott Children's Hospital, Ann Arbor, Michigan, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Ascension Saint John Hospital, Detroit, Michigan, United States

Michigan State University Clinical Center, East Lansing, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States

Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

Mayo Clinic in Rochester, Rochester, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital Saint Louis, Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States

Summerlin Hospital Medical Center, Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Morristown Medical Center, Morristown, New Jersey, United States

Saint Peter's University Hospital, New Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center, Newark, New Jersey, United States

Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States

Albany Medical Center, Albany, New York, United States

Montefiore Medical Center - Moses Campus, Bronx, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

NYU Winthrop Hospital, Mineola, New York, United States

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States

Mount Sinai Hospital, New York, New York, United States

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

New York Medical College, Valhalla, New York, United States

Mission Hospital, Asheville, North Carolina, United States

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States

Novant Health Presbyterian Medical Center, Charlotte, 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

Children's Hospital Medical Center of Akron, Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Nationwide Children's Hospital, Columbus, Ohio, United States

Dayton Children's Hospital, Dayton, Ohio, United States

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Legacy Emanuel Children's Hospital, Portland, Oregon, United States

Oregon Health and Science University, Portland, Oregon, United States

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania, United States

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States

T C Thompson Children's Hospital, Chattanooga, Tennessee, United States

East Tennessee Childrens Hospital, Knoxville, Tennessee, United States

The Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

Dell Children's Medical Center of Central Texas, Austin, Texas, United States

Driscoll Children's Hospital, Corpus Christi, Texas, United States

Medical City Dallas Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

El Paso Children's Hospital, El Paso, Texas, United States

Cook Children's Medical Center, Fort Worth, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

Covenant Children's Hospital, Lubbock, Texas, United States

Children's Hospital of San Antonio, San Antonio, Texas, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas, United States

Scott and White Memorial Hospital, Temple, Texas, United States

Primary Children's Hospital, Salt Lake City, Utah, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Inova Fairfax Hospital, Falls Church, Virginia, United States

Children's Hospital of The King's Daughters, Norfolk, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Carilion Children's, Roanoke, Virginia, United States

Seattle Children's Hospital, Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

West Virginia University Charleston Division, Charleston, West Virginia, United States

West Virginia University Healthcare, Morgantown, West Virginia, United States

Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Perth Children's Hospital, Perth, Western Australia, Australia

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada

IWK Health Centre, Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Children's Hospital, London, Ontario, Canada

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada

Hospital for Sick Children, Toronto, Ontario, Canada

The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada

Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

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

Starship Children's Hospital, Grafton, Auckland, New Zealand

Christchurch Hospital, Christchurch, , New Zealand

HIMA San Pablo Oncologic Hospital, Caguas, , Puerto Rico

San Jorge Children's Hospital, San Juan, , Puerto Rico

University Pediatric Hospital, San Juan, , Puerto Rico

Contact Details

Name: Patrick A Brown

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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