Back to resultsCombination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
doxorubicin hydrochloride
leucovorin calcium
mercaptopurine
methotrexate
prednisone
thioguanine
vincristine sulfate
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma
Eligibility 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 lymphoblastic 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
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- City of Hope Comprehensive Cancer Center
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Childrens Hospital Los Angeles
- Jonsson Comprehensive Cancer Center at UCLA
- Children's Hospital Central California
- Children's Hospital of Orange County
- Sutter Cancer Center
- University of California Davis Cancer Center
- Kaiser Permanente Medical Center - Oakland
- Children's Hospital and Health Center - San Diego
- UCSF Comprehensive Cancer Center
- Stanford Comprehensive Cancer Center - Stanford
- Children's Hospital Cancer Center
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Children's National Medical Center
- Broward General Medical Center Cancer Center
- Lee Cancer Care of Lee Memorial Health System
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Nemours Children's Clinic
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Miami Children's Hospital
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- M.D. Anderson Cancer Center at Orlando
- Nemours Children's Clinic - Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- Winship Cancer Institute of Emory University
- MBCCOP - Medical College of Georgia Cancer Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- St. Luke's Mountain States Tumor Institute - Boise
- University of Illinois Cancer Center
- Children's Memorial Hospital - Chicago
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Indiana University Melvin and Bren Simon Cancer Center
- Blank Children's Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Kosair Children's Hospital
- Tulane Cancer Center
- Children's Hospital of New Orleans
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- CancerCare of Maine at Eastern Maine Medial Center
- Maine Children's Cancer Program at Barbara Bush Children's Hospital
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children at Tufts - New England Medical Center
- C.S. Mott Children's Hospital at University of Michigan Medical Center
- Barbara Ann Karmanos Cancer Institute
- Hurley Medical Center
- Spectrum Health Hospital - Butterworth Campus
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- CCOP - Kalamazoo
- Breslin Cancer Center at Ingham Regional Medical Center
- William Beaumont Hospital - Royal Oak Campus
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota Children's Hospital - Fairview
- Mayo Clinic Cancer Center
- University of Mississippi Cancer Clinic
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital
- Children's Hospital
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
- Hackensack University Medical Center Cancer Center
- St. Barnabas Medical Center Cancer Center
- Overlook Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- University of New Mexico Cancer Research and Treatment Center
- Brooklyn Hospital Center
- Roswell Park Cancer Institute
- Winthrop University Hospital
- Schneider Children's Hospital
- NYU Cancer Institute at New York University Medical Center
- Mount Sinai Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Stony Brook University Cancer Center
- SUNY Upstate Medical University Hospital
- New York Medical College
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Comprehensive Cancer Center
- Leo W. Jenkins Cancer Center at ECU Medical School
- Wake Forest University Comprehensive Cancer Center
- CCOP - MeritCare Hospital
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Columbus Children's Hospital
- Children's Medical Center - Dayton
- Toledo Hospital
- Medical University of Ohio Cancer Center
- Tod Children's Hospital
- Oklahoma University Cancer Institute
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Oregon Health & Science University Cancer Institute
- Geisinger Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Rhode Island Hospital Comprehensive Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- Greenville Hospital System Cancer Center
- Sanford Cancer Center at Sanford USD Medical Center
- T.C. Thompson Children's Hospital
- East Tennessee Children's Hospital
- St. Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Children's Hospital of Austin
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Baylor University Medical Center - Houston
- M. D. Anderson Cancer Center at University of Texas
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- CCOP - Scott and White Hospital
- Primary Children's Medical Center
- Fletcher Allen Health Care - University Health Center Campus
- University of Virginia Cancer Center
- INOVA Fairfax Hospital
- Children's Hospital of The King's Daughters
- Virginia Commonwealth University Massey Cancer Center
- Carilion Cancer Center of Western Virginia
- Children's Hospital and Regional Medical Center - Seattle
- Providence Cancer Center at Sacred Heart Medical Center
- Mary Bridge Children's Hospital and Health Center - Tacoma
- Madigan Army Medical Center - Tacoma
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- St. Vincent Hospital Regional Cancer Center
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
- Marshfield Clinic - Marshfield Center
- Prince of Wales Private Hospital
- Royal Children's Hospital
- Women's and Children's Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Allan Blair Cancer Centre at Pasqua Hospital
- Saskatoon Cancer Centre at the University of Saskatchewan
- Centre Hospitalier Universitaire de Quebec
- San Jorge Children's Hospital
- Swiss Pediatric Oncology Group Bern
- Swiss Pediatric Oncology Group Geneva
- Swiss Pediatric Oncology Group Lausanne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
A0 (localized disease Stg I/II) Modified CCG BFM
A1 (Disseminated, No CNS - CCG mod BFM w/out intens
A2 (Disseminated, No CNS - CCG mod BFM w/ intens
B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Outcomes
Primary Outcome Measures
Event-free Survival
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
Secondary Outcome Measures
Percentage of Patients With Overall Survival as Assessed by Time to Death
Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
Full Information
NCT ID
NCT00004228
First Posted
January 28, 2000
Last Updated
July 24, 2019
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00004228
Brief Title
Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
Official Title
Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
March 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
393 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A0 (localized disease Stg I/II) Modified CCG BFM
Arm Type
Experimental
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
Arm Title
A1 (Disseminated, No CNS - CCG mod BFM w/out intens
Arm Type
Experimental
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
Arm Title
A2 (Disseminated, No CNS - CCG mod BFM w/ intens
Arm Type
Experimental
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Arm Title
B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
Arm Type
Experimental
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Arm Title
B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens
Arm Type
Experimental
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Arm Title
B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
Arm Type
Experimental
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Arm Title
B1 (Disseminated CNS-) NHL/BFM-95 w/out intens
Arm Type
Experimental
Arm Description
Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
Intervention Type
Drug
Intervention Name(s)
asparaginase
Other Intervention Name(s)
E.coli L-asparaginase, EC 3.5.2.2, colaspase, L-asnase, Elspar, Kidrolase, Crasnitin, Leunase, NSC#109229
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan, NSC #26271
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cytarabine
Other Intervention Name(s)
cytosine arabinoside, Ara-C, Cytosar, NSC #63878
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Other Intervention Name(s)
daunomycin, rubidomycin, Cerubidine, NSC #82151
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Decadron, Hexadrol, Dexone, Dexameth, NSC #34521
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Other Intervention Name(s)
Adriamycin, NSC #123127
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Other Intervention Name(s)
LCV, Wellcovorin, citrovorum factor, folinic acid, NSC #003590
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
mercaptopurine
Other Intervention Name(s)
6-MP, Purinethol, 6-mercaptopurine, NSC #000755
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
methotrexate
Other Intervention Name(s)
MTX, amethopterin, Trexall, NSC #000740
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
prednisone
Other Intervention Name(s)
Deltasone, Meticorten, Orasone, Liquid Pred, Pediapred, Sterapred, NSC #010023
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
thioguanine
Other Intervention Name(s)
6-thioguanine, 2-amino-1,7-dihydro-6H-purine-6-thione, WR-1141, Tabloid, Lanvis, NSC # 751
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Other Intervention Name(s)
Oncovin, VCR, LCR, NSC #67574
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Event-free Survival
Description
Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Percentage of Patients With Overall Survival as Assessed by Time to Death
Description
Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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 lymphoblastic 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minnie Abromowitch, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242-2814
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Children's Hospital and Health Center - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Comprehensive Cancer Center - Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Children's Hospital Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1088
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-2875
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Broward General Medical Center Cancer Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Florida Hospital Cancer Institute at Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1273
Country
United States
Facility Name
M.D. Anderson Cancer Center at Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Nemours Children's Clinic - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Cancer Center at Sacred Heart Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
MBCCOP - Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3730
Country
United States
Facility Name
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
St. Luke's Mountain States Tumor Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712-6297
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
Tulane Cancer Center
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71315-3198
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Ochsner Cancer Institute at Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
CancerCare of Maine at Eastern Maine Medial Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Children's Cancer Program at Barbara Bush Children's Hospital
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Floating Hospital for Children at Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
C.S. Mott Children's Hospital at University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0238
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Spectrum Health Hospital - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5341
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Children's Hospital - Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4113
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
St. Barnabas Medical Center Cancer Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Overlook Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201-5493
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8174
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Leo W. Jenkins Cancer Center at ECU Medical School
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27835-6028
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-5217
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Medical University of Ohio Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Tod Children's Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel Hospital and Health Center & Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Science University Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-9786
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital Comprehensive Cancer Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Greenville Hospital System Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
T.C. Thompson Children's Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
East Tennessee Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine - Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Children's Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-9958
Country
United States
Facility Name
Baylor University Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3993
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113-1100
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
INOVA Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1971
Country
United States
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States
Facility Name
Carilion Cancer Center of Western Virginia
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24029
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-2555
Country
United States
Facility Name
Mary Bridge Children's Hospital and Health Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Madigan Army Medical Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Prince of Wales Private Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal Children's Hospital
City
Herston, Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Women's and Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Royal Children's Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Children's & Women's Hospital of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Janeway Children's Health and Rehabilitation Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Allan Blair Cancer Centre at Pasqua Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Swiss Pediatric Oncology Group Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Swiss Pediatric Oncology Group Geneva
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Swiss Pediatric Oncology Group Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22994934
Citation
Patel JL, Smith LM, Anderson J, Abromowitch M, Campana D, Jacobsen J, Lones MA, Gross TG, Cairo MS, Perkins SL. The immunophenotype of T-lymphoblastic lymphoma in children and adolescents: a Children's Oncology Group report. Br J Haematol. 2012 Nov;159(4):454-61. doi: 10.1111/bjh.12042. Epub 2012 Sep 21.
Results Reference
result
PubMed Identifier
22488718
Citation
Termuhlen AM, Smith LM, Perkins SL, Lones M, Finlay JL, Weinstein H, Gross TG, Abromowitch M. Outcome of newly diagnosed children and adolescents with localized lymphoblastic lymphoma treated on Children's Oncology Group trial A5971: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2012 Dec 15;59(7):1229-33. doi: 10.1002/pbc.24149. Epub 2012 Apr 5.
Results Reference
result
PubMed Identifier
19546402
Citation
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 Jul 20;27(21):3533-9. doi: 10.1200/JCO.2008.21.1318. Epub 2009 Jun 22.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
18618503
Citation
Smock KJ, Nelson M, Tripp SR, Sanger WG, Abromowitch M, Cairo MS, Perkins SL; Children's Oncology Group. 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 Oct;51(4):489-94. doi: 10.1002/pbc.21666.
Results Reference
result
Citation
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.
Results Reference
result
Learn more about this trial
Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma
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