Know Cancer

forgot password

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

Phase 3
20 Years
Not Enrolling

Thank you

Trial Information

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


- 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

OUTLINE: This is a randomized, multicenter study.

- Induction therapy: 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 CNS disease
at diagnosis receive additional methotrexate IT on days 15, 29, and 36).

Patients then begin consolidation therapy on day 43.

- Consolidation therapy: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive course-specific regimens.

- 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.

- Arm II: Patients receive course-specific regimens.

- 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

- 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.

Inclusion Criteria


- Newly diagnosed advanced anaplastic large cell lymphoma

- CD30+ disease

- 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)

- AST or ALT less than 2.5 times ULN (unless due to lymphoma)


- Not specified


- Shortening fraction at least 27% by echocardiogram OR

- Ejection fraction at least 50% by radionuclide angiogram


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Event-free survival

Outcome Time Frame:

10 years

Safety Issue:


Principal Investigator

Jacqueline Kraveka, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina


United States: Federal Government

Study ID:




Start Date:

November 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • anaplastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Anaplastic



Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield, Massachusetts  01199
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Sutter Cancer Center Sacramento, California  95816
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
Schneider Children's Hospital New Hyde Park, New York  11042
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Driscoll Children's Hospital Corpus Christi, Texas  78466
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Brooklyn Hospital Center Brooklyn, New York  11201
Children's Medical Center - Dayton Dayton, Ohio  45404
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee, Wisconsin  53226
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Overlook Hospital Summit, New Jersey  07902-0220
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Kaiser Permanente Medical Center - Oakland Sacramento, California  95825
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
Broward General Medical Center Cancer Center Ft. Lauderdale, Florida  33316
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach, Florida  33407
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Advocate Christ Medical Center Oak Lawn, Illinois  60453
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Blank Children's Hospital Des Moines, Iowa  50309
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore, Maryland  21215
Floating Hospital for Children at Tufts - New England Medical Center Boston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Rainbow Babies and Children's Hospital Cleveland, Ohio  44106-5000
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
Memorial Cancer Institute at Memorial Regional Hospital Hollywood, Florida  33021
Rady Children's Hospital - San Diego San Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Children's Hospital Center for Cancer and Blood Disorders Aurora, Colorado  80045
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
M.D. Anderson Cancer Center at Orlando Orlando, Florida  32806
MBCCOP - Medical College of Georgia Cancer Center Augusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise, Idaho  83712-6297
Advocate Lutheran General Cancer Care Center Park Ridge, Illinois  60068-1174
Simmons Cooper Cancer Institute Springfield, Illinois  62794-9677
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota  55404
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Children's Hospital Omaha, Nebraska  68114-4113
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York, New York  10032
Akron Children's Hospital Akron, Ohio  44308-1062
Nationwide Children's Hospital Columbus, Ohio  43205-2696
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health Center and Children's Hospital Portland, Oregon  97227
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Dell Children's Medical Center of Central Texas Austin, Texas  78723
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia  23298-0037
Carilion Medical Center for Children at Roanoke Community Hospital Roanoke, Virginia  24014
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma, Washington  98405
West Virginia University Health Sciences Center - Charleston Charleston, West Virginia  25302
Stanford Cancer Center Stanford, California  94305-5824
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Leo W. Jenkins Cancer Center at ECU Medical School Greenville, North Carolina  27834
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania  18017
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294
Greenville Hospital Cancer Center Greenville, South Carolina  29605
T.C. Thompson Children's Hospital Chattanooga, Tennessee  37403
Oregon Health and Science University Cancer Institute Portland, Oregon  97239-3098