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Combination Chemotherapy in Treating Children or Adolescents With Newly Diagnosed Stage III or Stage IV Lymphoblastic Lymphoma
This study has been completed.
First Received: January 28, 2000   Last Updated: July 10, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004228
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.

PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.


Condition Intervention Phase
Lymphoma
 Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Dexamethasone Cyclophosphamide 6-Mercaptopurine Prednisone Vincristine Leucovorin Methotrexate Cytarabine hydrochloride Daunorubicin Doxorubicin Daunorubicin hydrochloride Doxorubicin hydrochloride Citrovorum factor Dexamethasone acetate Doxiproct plus Myocet Cytarabine Thioguanine Leucovorin Calcium Dexamethasone Sodium Phosphate Vincristine sulfate Folinic acid calcium salt pentahydrate Mercaptopurine L-Asparaginase
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival as assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival as assessed by time to death [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2000
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma*

    • Less than 25% tumor cells in the bone marrow
    • Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
    • Stage III or IV disease
  • NOTE: *Localized lymphblastic lymphoma is closed to accrual as of 10/2005

PATIENT CHARACTERISTICS:

Age:

  • 1 to 30

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • Adequate cardiac function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy

Radiotherapy:

  • Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy

Surgery:

  • Not specified

Other:

  • No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004228

  Hide Study Locations
Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
Children's Hospital Central California
Madera, California, United States, 93638-8762
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
Children's Hospital of Orange County
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Southern California Permanente Medical Group
Downey, California, United States, 90242-2814
Stanford Comprehensive Cancer Center - Stanford
Stanford, California, United States, 94305
Sutter Cancer Center
Sacramento, California, United States, 95816
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
Children's Hospital Cancer Center
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Broward General Medical Center Cancer Center
Ft. Lauderdale, Florida, United States, 33316
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Miami Children's Hospital
Miami, Florida, United States, 33155
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-3730
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712-6297
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Tulane Cancer Center
Alexandria, Louisiana, United States, 71315-3198
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program at Barbara Bush Children's Hospital
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0238
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-5341
Hurley Medical Center
Flint, Michigan, United States, 48503
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Children's Hospital - Fairview
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68114-4113
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109-2306
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Overlook Hospital
Morristown, New Jersey, United States, 07962
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Medical College
Valhalla, New York, United States, 10595
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-8174
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27835-6028
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404-1815
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-5217
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-9786
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States, 29605
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Children's Hospital of Austin
Austin, Texas, United States, 78701
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104-9958
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States, 79106
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05405
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507-1971
INOVA Fairfax Hospital
Fairfax, Virginia, United States, 22031
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24029
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States, 98405
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99220-2555
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Australia, New South Wales
Prince of Wales Private Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Royal Children's Hospital
Herston, Brisbane, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada
Centre Hospitalier Universitaire de Quebec
Quebec, Canada, G1V 4G2
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 3N6
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Children's Hospital of Western Ontario
London, Ontario, Canada, N6A 4G5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Puerto Rico
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, 3010
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, 1205
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Minnie Abromowitch, MD Children's Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Coustan-Smith E, Sandlund JT, Perkins SL, Chen H, Chang M, Abromowitch M, Campana D. Minimal Disseminated Disease in Childhood T-Cell Lymphoblastic Lymphoma: A Report From the Children's Oncology Group. J Clin Oncol. 2009 Jun 22; [Epub ahead of print]
Abromowitch M, Termuhlen A, Chang M, et al.: High-dose methotrexate and early intensification of therapy do not improve 3 year EFS in children and adolescents with disseminated lymphoblastic lymphoma: results of the randomized arms of COG A5971. [Abstract] Blood 112 (11): A-3610, 2008.
Smock KJ, Nelson M, Tripp SR, Sanger WG, Abromowitch M, Cairo MS, Perkins SL. Characterization of childhood precursor T-lymphoblastic lymphoma by immunophenotyping and fluorescent in situ hybridization: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2008 Jul 10; [Epub ahead of print]
Coustan-Smith E, Abromowitz M, Sandlund JT, et al.: A novel approach for minimal residual disease detection in childhood T-cell lymphoblastic lymphoma (T-LL): a Children's Oncology Group report. [Abstract] Blood 110 (11): A-3564, 2007.

Study ID Numbers: CDR0000067470, COG-A5971, CCG-59701, CCG-59701C, CCG-A5971, POG-A5971
Study First Received: January 28, 2000
Last Updated: July 10, 2009
ClinicalTrials.gov Identifier: NCT00004228     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Prednisone
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
6-Mercaptopurine
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
 Nucleic Acid Synthesis Inhibitors
Asparaginase
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Immune System Diseases
Thioguanine
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites

ClinicalTrials.gov processed this record on November 27, 2009



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