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Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma


Phase 3
1 Year
30 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma


OBJECTIVES:

- Compare the event-free survival and overall survival of children or adolescents with
newly diagnosed disseminated stage III or IV lymphoblastic lymphoma treated with 4
chemotherapy regimens*.

- Determine whether treatment with a regimen without methotrexate maintains the same
disease-free survival as NHL/BFM 90 in these patients.

- Determine whether intensification with anthracycline and cyclophosphamide improves
disease-free survival in these patients.

- Collect outcome data on uniformly treated patients with localized disease or
CNS-positive disease.

- Determine whether rapid reduction in tumor volume by chest radiography and CT scan is
predictive of improved outcome in patients treated with these regimens.

- Determine the prevalence of bone marrow involvement at presentation in these patients.

- Determine whether peripheral blood can replace bone marrow in the initial staging of
these patients.

- Determine the clinical significance of bone marrow and peripheral blood involvement in
these patients.

NOTE: *All patients as of 4/2006 receive treatment on Arm III regimen only

OUTLINE: Patients are stratified by disease characteristics (disseminated lymphoblastic
lymphoma vs localized lymphoblastic lymphoma [localized lymphoblastic lymphoma is closed to
accrual as of 10/2005]) and age. Patients with CNS negative disseminated lymphoblastic
lymphoma are randomized to 1 of 4 treatment arms*. Patients with testicular involvement at
diagnosis are nonrandomly assigned to arm IV and do not receive testicular radiotherapy.
Patients with localized lymphoblastic lymphoma (closed to accrual as of 10/2005) are not
randomized.

NOTE: *All patients as of 4/2006 receive treatment on Arm III only

- Localized lymphoblastic lymphoma (closed to accrual as of 10/2005):

- Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over 15
minutes to 2 hours on days 0, 7, 14, and 21; oral prednisone on days 0-27; and
asparaginase intramuscularly (IM) on days 3, 5, and 7 and then 3 times a week for
9 doses (during days 8-21). Patients also receive methotrexate intrathecally (IT)
on days 7 and 28 and cytarabine IT on day 0.

- Consolidation (5 weeks): Patients receive methotrexate IT on days 0, 7, 14, and 21
followed by cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV on
days 0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral
prednisone over 10 days.

- Interim maintenance (8 weeks): Patients receive methotrexate IT on days 0 and 28;
oral mercaptopurine on days 0-41; and oral methotrexate on days 7, 14, 21, and 35.

- Delayed intensification (7 weeks): Patients receive vincristine IV and doxorubicin
IV over 15 minutes to 2 hours on days 0, 7, and 14; asparaginase IM on day 3 and
then 3 times a week for 6 doses; oral dexamethasone on days 0-30; cyclophosphamide
IV over 1 hour on day 28; and cytarabine IV or SC on days 28-31 and 35-38.
Patients also receive oral thioguanine on days 28-41 and methotrexate IT on days
28 and 35.

- Maintenance (84 day course): Patients receive vincristine IV on days 0, 28, and
56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on days 7,
14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; oral mercaptopurine on days 0-83; and
methotrexate IT on day 0.

- Disseminated lymphoblastic lymphoma:

- Arm I (closed to accrual as of 4/2006): Patients receive same induction,
consolidation, and interim maintenance therapy schedule as localized lymphoblastic
lymphoma patients.

- Delayed intensification (7 weeks): Patients receive vincristine IV and
doxorubicin IV over 15 minutes to 2 hours on days 0, 7, 14, and 21;
asparaginase IM on day 3 and then 3 times a week for 6 doses; and oral
dexamethasone on days 0-28. Patients also receive cyclophosphamide IV over 1
hour on day 35; cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine
on days 35-48; and methotrexate IT on days 35 and 42.

- Maintenance (84 day course): Patients receive same therapy as localized
lymphoblastic lymphoma patients, except methotrexate IT is administered on
day 0 and 28 (for first 4 courses).

- Arm II (closed to accrual as of 4/2006): Patients receive consolidation, interim
maintenance, and maintenance therapy as in arm I.

- Induction (5 weeks): Patients receive vincristine IV on days 0, 7, 14, and
21; daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-27;
and asparaginase IM on days 3, 5, and 7 and then 3 times a week for 9 doses
(during days 8-21). Patients also receive methotrexate IT on days 7 and 28;
cyclophosphamide IV over 1 hour on day 2; and cytarabine IT on day 0.

- Delayed intensification (7 weeks): Patients receive vincristine IV on days 0,
7, 14, 21; daunorubicin IV over 48 hours on days 0-2; asparaginase IM on day
3 and then 3 times a week for 6 doses; and oral dexamethasone on days 0-28.
Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35;
cytarabine IV or SC on days 35-38 and 42-45; oral thioguanine on days 35-48;
and methotrexate IT on days 35 and 42.

- Arm III:

- Induction (5 weeks): Patients receive vincristine IV and daunorubicin IV over
1 hour on days 0, 7, 14, and 21 and oral prednisone on days 0-37. Patients
also receive asparaginase IM on day 11 and then 3 times a week for 9 doses;
methotrexate IT on days 7 and 28; and cytarabine IT on day 0.

- Consolidation (5 weeks): Patients receive methotrexate IT and
cyclophosphamide IV over 1 hour on days 0 and 14; cytarabine IV or SC on days
0-3, 7-10, 14-17, and 21-24; oral mercaptopurine on days 0-27; and oral
prednisone over 10 days.

- Interim maintenance (9 weeks): Patients receive methotrexate IT and IV on
days 7, 21, 35, and 49; oral mercaptopurine on days 0-55; and leucovorin
calcium IV at 42, 48, and 54 hours after methotrexate IV.

- Delayed intensification (10 weeks): Patients receive vincristine IV and
doxorubicin IV over 1 hour on days 0, 7, 14, and 21; asparaginase IM on day 3
and then 3 times a week for 6 doses; and oral dexamethasone on days 0-29.
Patients also receive cyclophosphamide IV over 1 hour on day 35; cytarabine
IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and methotrexate
IT on days 35 and 42.

- Maintenance (84 day courses): Patients receive vincristine IV on days 0, 28,
and 56; oral prednisone on days 0-4, 28-32, and 56-60; oral methotrexate on
days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, and 77; and oral mercaptopurine
on days 0-83.

- Arm IV (closed to accrual as of 4/2006): Patients receive consolidation and
interim maintenance therapy as in arm III.

- Induction: Patients receive vincristine IV on days 0, 7, 14, and 21;
daunorubicin IV over 48 hours on days 0-2; oral prednisone on days 0-37;
asparaginase IM on day 11 and then 3 times a week for 9 doses; methotrexate
IT on days 7, 14, 21, and 28; cyclophosphamide IV on day 2; and cytarabine IT
on day 0.

- Delayed intensification (10 weeks): Patients receive vincristine IV on days
7, 14, 21, and 28; daunorubicin IV over 48 hours on days 0-2; asparaginase IM
on day 3 and then 3 times a week for 6 doses; and oral dexamethasone on days
0-29. Patients also receive cyclophosphamide IV over 1 hour on days 2 and 35;
cytarabine IV on days 35-38 and 42-45; oral thioguanine on days 35-48; and
methotrexate IT on days 35 and 42.

- Maintenance (84 day courses): Patients receive therapy as in arm III.
Patients who are over 1 year of age and have CNS disease at diagnosis undergo
cranial radiotherapy once daily 5 days a week beginning on day 0. Patients
over 2 years of age undergo radiotherapy over 11-14 days (6-9 days for 1-2
years of age).

Patients are followed monthly for one year, every 3 months for 1 year, every 6 months for
1.5 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 250-400 patients will be accrued for this study within 5
years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Event-free survival as assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause

Safety Issue:

No

Principal Investigator

Minnie Abromowitch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati

Authority:

United States: Federal Government

Study ID:

CDR0000067470

NCT ID:

NCT00004228

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
CCOP - MeritCare HospitalFargo, North Dakota  58122
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sutter Cancer CenterSacramento, California  95816
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
University of California Davis Cancer CenterSacramento, California  95817
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Children's Hospital of AustinAustin, Texas  78701
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
Winthrop University HospitalMineola, New York  11501
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Blank Children's HospitalDes Moines, Iowa  50309
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Mount Sinai Medical CenterNew York, New York  10029
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Carilion Cancer Center of Western VirginiaRoanoke, Virginia  24029
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Childrens Hospital Los AngelesLos Angeles, California  90027
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Maine Children's Cancer Program at Barbara Bush Children's HospitalScarborough, Maine  04074-9308
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Children's HospitalOmaha, Nebraska  68114-4113
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Tod Children's HospitalYoungstown, Ohio  44501
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - TacomaTacoma, Washington  98405
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Children's Hospital Cancer CenterDenver, Colorado  80218
Columbus Children's HospitalColumbus, Ohio  43205-2696
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Tulane Cancer CenterNew Orleans, Louisiana  70112
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305
University of Minnesota Children's Hospital - FairviewMinneapolis, Minnesota  55455
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
T.C. Thompson Children's HospitalChattanooga, Tennessee  37403