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Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma

Information source: Children's Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: doxorubicin hydrochloride (Drug); mercaptopurine (Drug); methotrexate (Drug); prednisone (Drug); vinblastine sulfate (Drug); vincristine sulfate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Children's Oncology Group

Official(s) and/or principal investigator(s):
Jacqueline Kraveka, DO, Study Chair, Affiliation: Medical University of South Carolina


RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.

Clinical Details

Official title: A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) With Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation With a Regimen Including Vinblastine

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Event-free Survival (EFS)

Detailed description: OBJECTIVES:

- Compare the efficacy of a consolidation chemotherapy regimen comprising doxorubicin and

prednisone in combination with vincristine vs vinblastine, in terms of event-free survival, in patients with advanced anaplastic large cell lymphoma.

- Compare overall survival of patients treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

- Correlate biological tumor characteristics and outcome in patients treated with these

regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized at enrollment to receive either Standard APO regimen or a consolidation regimen including vinblastine (VBL).

- Induction therapy: All Patients receive doxorubicin IV over 15 minutes on days 1 and

22; vincristine IV on days 1, 8, 15, 22, and 29; oral prednisone 3 times daily on days 1-28; and intrathecal (IT) methotrexate on days 1, 8, and 22 (patients with central nervous system (CNS) disease at diagnosis receive additional methotrexate IT on days 15, 29, and 36). Patients undergo restaging after Induction such that consolidation therapy is started on day 43. All patients with complete response (CR), complete response unconfirmed (CRu) or partial response (PR) proceed to Consolidation based on CT or MRI scans at the end of induction (week 6). All other patients will be removed from protocol therapy and will be followed until they meet the criteria for off study. Follow-up data will be required unless consent is withdrawn.

- Standard APO (Arm I): Patients receive course-specific regimens without vinblastine.

- Courses 1-3: Patients receive doxorubicin IV over 15 minutes, vincristine IV, and

methotrexate IT on day 1 and oral prednisone three times daily and oral mercaptopurine once daily on days 1-5.

- Courses 4-5: Patients receive doxorubicin, vincristine, prednisone, and

mercaptopurine as in courses 1-3.

- Courses 6-15: Patients receive vincristine, prednisone, and mercaptopurine as in

courses 1-3 and methotrexate IV on day 1.

- Consolidation with vinblastine (Arm II): Patients receive course-specific regimens

including vinblastine.

- Courses 1-3: Patients receive doxorubicin, methotrexate IT, prednisone, and

mercaptopurine as in arm I and vinblastine IV over 1 minute on days 1, 8, and 15.

- Courses 4-5: Patients receive doxorubicin, prednisone, and mercaptopurine as in

arm I and vinblastine as in arm II (courses 1-3).

- Courses 6-15: Patients receive prednisone and mercaptopurine as in arm I,

vinblastine as in arm II (courses 1-3), and methotrexate IV on day 1. In both arms and all courses, treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 200-250 patients (100-125 per treatment arm) will be accrued for this study within 5 years.


Minimum age: N/A. Maximum age: 20 Years. Gender(s): Both.



- Newly diagnosed advanced anaplastic large cell lymphoma

- Cluster of differentiation antigen 30 (CD30+)

- Murphy stage III or IV

- No B-cell large cell lymphoma

- No disease limited to the skin (regardless of how wide-spread)


- Under 21

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Bilirubin no greater than 1. 5 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST) or alanine transaminase (ALT) less than 2. 5 times

ULN (unless due to lymphoma) Renal

- Not specified


- Shortening fraction (SF) at least 27% by echocardiogram OR

- Ejection fraction (EF) at least 50% by radionuclide angiogram


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


- Not specified


- Not specified

Endocrine therapy

- Prior steroids for management of a mediastinal mass allowed


- Prior limited-dose radiotherapy for a mediastinal mass allowed


- Not specified

Locations and Contacts

Centre Hospitalier Universitaire de Quebec, Quebec G1V 4G2, Canada

San Jorge Children's Hospital, Santurce 00912, Puerto Rico

Swiss Pediatric Oncology Group Bern, Bern 3010, Switzerland

Swiss Pediatric Oncology Group Geneva, Geneva 1205, Switzerland

Swiss Pediatric Oncology Group Lausanne, Lausanne 1011, Switzerland

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama 35294, United States

Alberta Children's Hospital, Calgary, Alberta T3B 6A8, Canada

University of Alberta Hospital, Edmonton, Alberta T6G 1Z2, Canada

Phoenix Children's Hospital, Phoenix, Arizona 85016-7710, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Children's & Women's Hospital of British Columbia, Vancouver, British Columbia V6H 3V4, Canada

Southern California Permanente Medical Group, Downey, California 90027, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California 92354, United States

Children's Hospital Central California, Madera, California 93638-8762, United States

Children's Hospital of Orange County, Orange, California 92868, United States

Kaiser Permanente Medical Center - Oakland, Sacramento, California 95825, United States

Sutter Cancer Center, Sacramento, California 95816, United States

Rady Children's Hospital - San Diego, San Diego, California 92123-4282, United States

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States

Stanford Cancer Center, Stanford, California 94305-5824, United States

Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado 80045, United States

Presbyterian - St. Luke's Medical Center, Denver, Colorado 80218, United States

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut 06360-2875, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware 19803, United States

Children's National Medical Center, Washington, District of Columbia 20010-2970, United States

Broward General Medical Center Cancer Center, Fort Lauderdale, Florida 33316, United States

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida 33901, United States

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida 33021, United States

Nemours Children's Clinic, Jacksonville, Florida 32207, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida 33176, United States

Miami Children's Hospital, Miami, Florida 33155, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida 33136, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida 32803-1273, United States

M.D. Anderson Cancer Center at Orlando, Orlando, Florida 32806, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida 32504, United States

All Children's Hospital, St. Petersburg, Florida 33701, United States

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida 33607, United States

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida 33407, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia 30322, United States

MBCCOP - Medical College of Georgia Cancer Center, Augusta, Georgia 30912-3730, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia 31403-3089, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii 96813, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center, Boise, Idaho 83712-6297, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois 60614, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Advocate Christ Medical Center, Oak Lawn, Illinois 60453, United States

Advocate Lutheran General Cancer Care Center, Park Ridge, Illinois 60068-1174, United States

Saint Jude Midwest Affiliate, Peoria, Illinois 61637, United States

Simmons Cooper Cancer Institute, Springfield, Illinois 62794-9677, United States

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202-5289, United States

St. Vincent Indianapolis Hospital, Indianapolis, Indiana 46260, United States

Blank Children's Hospital, Des Moines, Iowa 50309, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1002, United States

Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky 40536-0093, United States

Kosair Children's Hospital, Louisville, Kentucky 40232, United States

Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana 71315-3198, United States

CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland 21215, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts 02111, United States

Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts 01199-0001, United States

C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan 48109-0286, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

Hurley Medical Center, Flint, Michigan 48503, United States

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan 49503-2560, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan 48236, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-5381, United States

Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan 48910, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota 55404, United States

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota 55455, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

University of Mississippi Cancer Clinic, Jackson, Mississippi 39216-4505, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Children's Mercy Hospital, Kansas City, Missouri 64108, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St. Louis, Missouri 63110, United States

Children's Hospital, Omaha, Nebraska 68114-4113, United States

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-6805, United States

CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89109-2306, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756-0002, United States

Hackensack University Medical Center Cancer Center, Hackensack, New Jersey 07601, United States

Overlook Hospital, Morristown, New Jersey 07962, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

St. Joseph's Hospital and Medical Center, Paterson, New Jersey 07503, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico 87131-5636, United States

Westmead Institute for Cancer Research at Westmead Hospital, Westmead, New South Wales 2145, Australia

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York 10461, United States

Brooklyn Hospital Center, Brooklyn, New York 11201-5493, United States

Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States

Schneider Children's Hospital, New Hyde Park, New York 11040, United States

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, New York 10032, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

SUNY Upstate Medical University Hospital, Syracuse, New York 13210, United States

New York Medical College, Valhalla, New York 10595, United States

Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador A1B 3V6, Canada

Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina 28233-3549, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina 27835-6028, United States

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina 27157-1096, United States

CCOP - MeritCare Hospital, Fargo, North Dakota 58122, United States

IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada

Akron Children's Hospital, Akron, Ohio 44308-1062, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States

Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106-5000, United States

Nationwide Children's Hospital, Columbus, Ohio 43205-2696, United States

Children's Medical Center - Dayton, Dayton, Ohio 45404-1815, United States

Medical University of Ohio Cancer Center, Toledo, Ohio 43614, United States

Toledo Hospital, Toledo, Ohio 43606, United States

Oklahoma University Cancer Institute, Oklahoma City, Oklahoma 73104, United States

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario L8N 3Z5, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario K7L 2V7, Canada

Children's Hospital of Western Ontario, London, Ontario N6A 5W9, Canada

Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

Legacy Emanuel Hospital and Health Center and Children's Hospital, Portland, Oregon 97227, United States

Oregon Health and Science University Cancer Institute, Portland, Oregon 97239-3098, United States

Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania 18017, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania 17822-0001, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania 19134-1095, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Hopital Sainte Justine, Montreal, Quebec H3T 1C5, Canada

Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec H3H 1P3, Canada

Royal Children's Hospital, Brisbane, Queensland 4029, Australia

Rhode Island Hospital Comprehensive Cancer Center, Providence, Rhode Island 02903, United States

Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan S4T 7T1, Canada

Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan S7N 4H4, Canada

Greenville Hospital Cancer Center, Greenville, South Carolina 29605, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States

T.C. Thompson Children's Hospital, Chattanooga, Tennessee 37403, United States

East Tennessee Children's Hospital, Knoxville, Tennessee 37901, United States

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas 79106, 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

Medical City Dallas Hospital, Dallas, Texas 75230, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States

Cook Children's Medical Center - Fort Worth, Fort Worth, Texas 76104, United States

Baylor University Medical Center - Houston, Houston, Texas 77030-2399, United States

M. D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States

Covenant Children's Hospital, Lubbock, Texas 79410, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas 78229-3993, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78207, United States

Primary Children's Medical Center, Salt Lake City, Utah 84113-1100, United States

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont 05401, United States

Children's Hospital of The King's Daughters, Norfolk, Virginia 23507-1971, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Carilion Medical Center for Children at Roanoke Community Hospital, Roanoke, Virginia 24014, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington 98105, United States

Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington 99220-2555, United States

Mary Bridge Children's Hospital and Health Center - Tacoma, Tacoma, Washington 98405, United States

West Virginia University Health Sciences Center - Charleston, Charleston, West Virginia 25302, United States

Princess Margaret Hospital for Children, Perth, Western Australia 6001, Australia

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States

Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin 54449, United States

Midwest Children's Cancer Center at Children's Hospital of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: November 2003
Last updated: September 10, 2014

Page last updated: August 23, 2015

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