Back to resultsCombination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Primary Purpose
Leukemia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
filgrastim
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
etoposide
leucovorin calcium
mercaptopurine
methotrexate
pegaspargase
therapeutic hydrocortisone
vincristine sulfate
radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, TdT positive childhood acute lymphoblastic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of acute lymphoblastic leukemia (ALL) B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10) In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis First isolated CNS and/or testicular relapse Isolated CNS relapse, as defined by 1 of the following: WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following: Identifiable blasts AND 1 of the following: B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart) T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10) Isolated testicular relapse, defined as biopsy proven testicular involvement No Down syndrome No T-cell ALL or T-cell non-Hodgkin lymphoma No known optic nerve and/or retinal involvement PATIENT CHARACTERISTICS: Age 18 months to 29 years at relapse Performance status Karnofsky 30-100% (for patients > 16 years of age) OR Lansky 30-100% (for patients ≤ 16 years of age) Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Creatinine adjusted according to age as follows: No greater than 0.4 mg/dL (≤ 5 months) No greater than 0.5 mg/dL (6 months -11 months) No greater than 0.6 mg/dL (1 year-23 months) No greater than 0.8 mg/dL (2 years-5 years) No greater than 1.0 mg/dL (6 years-9 years) No greater than 1.2 mg/dL (10 years-12 years) No greater than 1.4 mg/dL (13 years and over [female]) No greater than 1.5 mg/dL (13 years to 15 years [male]) No greater than 1.7 mg/dL (16 years and over [male]) OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Cardiovascular Shortening fraction ≥ 27% by echocardiogram OR Ejection fraction ≥ 50% by MUGA Other Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy No prior bone marrow transplantation Chemotherapy Prior total anthracycline dosage ≤ 360 mg/m^2 Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No prior systemic therapy for concurrent extramedullary relapse
Sites / Locations
- UAB Comprehensive Cancer Center
- Phoenix Children's Hospital
- Arizona Cancer Center at University of Arizona Health Sciences Center
- 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 and Research Center Oakland
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital at Stanford University Medical Center
- Sutter Cancer Center
- Kaiser Permanente Medical Center - Oakland
- UCSF Helen Diller Family Comprehensive Cancer Center
- Children's Hospital Center for Cancer and Blood Disorders
- Presbyterian - St. Luke's Medical Center
- Connecticut Children's Medical Center
- Alfred I. duPont Hospital for Children
- 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
- Baptist-South Miami Regional Cancer Program
- 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
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
- Cancer Research Center of Hawaii
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- University of Illinois Cancer Center
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
- Advocate Lutheran General Cancer Care Center
- Simmons Cooper Cancer Institute
- Indiana University Melvin and Bren Simon Cancer Center
- St. Vincent Indianapolis Hospital
- Blank Children's Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Lucille P. Markey Cancer Center at University of Kentucky
- Kosair Children's Hospital
- CancerCare of Maine at Eastern Maine Medical Center
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- 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
- Butterworth Hospital at Spectrum Health
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- CCOP - Kalamazoo
- Breslin Cancer Center at Ingham Regional Medical Center
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- Mayo Clinic Cancer Center
- University of Mississippi Cancer Clinic
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Children's Mercy Hospital
- CCOP - Nevada Cancer Research Foundation
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Hackensack University Medical Center Cancer Center
- Overlook Hospital
- Saint Peter's University 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 Center
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Brooklyn Hospital Center
- Maimonides Cancer Center at Maimonides Medical Center
- Roswell Park Cancer Institute
- Winthrop University Hospital
- Schneider Children's Hospital
- NYU Cancer Institute at New York University 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
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Comprehensive Cancer Center
- Wake Forest University Comprehensive Cancer Center
- CCOP - MeritCare Hospital
- Akron Children's Hospital
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Nationwide Children's Hospital
- Dayton Children's - Dayton
- Medical University of Ohio Cancer Center
- Tod Children's Hospital
- Oklahoma University Cancer Institute
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Knight Cancer Institute at Oregon Health and Science University
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Cancer Institute at Geisinger Health
- Penn State Children's Hospital
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh of UPMC
- Rhode Island Hospital Comprehensive Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- Greenville Hospital Cancer Center
- Sanford Cancer Center at Sanford USD Medical Center
- T.C. Thompson Children's Hospital
- East Tennessee Children's Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- 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
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- Primary Children's Medical Center
- Fletcher Allen Health Care - University Health Center Campus
- Inova Fairfax Hospital
- Carilion Medical Center for Children at Roanoke Community Hospital
- Providence Cancer Center at Sacred Heart Medical Center
- West Virginia University Health Sciences Center - Charleston
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- Marshfield Clinic - Marshfield Center
- Midwest Children's Cancer Center at Children's Hospital of Wisconsin
- Princess Margaret Hospital for Children
- University of Alberta 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 Eastern Ontario
- Hopital Sainte Justine
- Allan Blair Cancer Centre at Pasqua Hospital
- Saskatoon Cancer Centre at the University of Saskatchewan
- Centre Hospitalier Universitaire de Quebec
- Starship Children's Health
- Christchurch 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 Type
Experimental
Experimental
Arm Label
CNS Patients-Treatment (combination chemotherapy)
Testicular Relapse Patients (Combination chemotherapy)
Arm Description
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Outcomes
Primary Outcome Measures
Event-free Survival
Monitoring of efficacy results will be performed in comparison with historical results.
Secondary Outcome Measures
Full Information
NCT ID
NCT00096135
First Posted
November 9, 2004
Last Updated
February 14, 2017
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00096135
Brief Title
Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
Official Title
Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)
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 work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.
Detailed Description
OBJECTIVES:
Primary
Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS relapse.
Determine the efficacy of intensive systemic chemotherapy without testicular radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular relapse.
Determine the toxicity of these regimens in these patients.
Secondary
Determine whether bone marrow involvement is present at the time of extramedullary relapse in patients treated with these regimens.
Correlate pretreatment minimal residual disease with outcomes in patients treated with these regimens.
Correlate the role of host gene polymorphisms with toxicity of these regimens and incidence and outcome in these patients.
Determine the neuropsychological sequelae associated with isolated CNS relapse and these treatment regimens in these patients.
OUTLINE: This is a pilot, multicenter study. All patients receive common induction, consolidation, re-induction, and intensification chemotherapy. Patients are stratified to maintenance therapy according to site of extramedullary relapse (CNS vs testicular).
Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate, hydrocortisone, and cytarabine on days 1, 8, 15, and 22.
NOTE: *The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose is reached, all subsequent doses of daunorubicin are omitted.
NOTE: **Patients with isolated testicular relapse receive ITT on day 1 only.
In addition to the above, patients with isolated testicular relapse also receive high-dose methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of disease at the end of induction undergo testicular biopsy.
Patients with CNS disease who do not achieve CNS remission after induction therapy receive additional ITT as above on days 29 and 36.
Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2 and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days 3 and 24 and continuing until blood counts recover.
Patients with isolated testicular relapse with positive biopsy results at the end of induction undergo testicular radiotherapy once daily for a total of 12 fractions during consolidation therapy.
Intensification I (weeks 11-22): Patients receive high-dose methotrexate with leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50, and 71. Patients receive ITT* on days 15, 36, 57, and 78.
NOTE: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.
Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15, and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over 15 minutes on days 1, 8, and 15.
Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86, and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over 24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76, 114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days 3, 45, 87, and 129 and continuing until blood counts recover.
NOTE: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.
Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM on days 1 and 15.
Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a week, for a total of 12 fractions.
Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days 1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10 weeks for 5 courses.
Maintenance therapy for isolated testicular relapse:
(Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine, methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.
(Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1, 8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also receive ITT on day 1 every 12 weeks for 3 doses.
Patients with combined testicular and CNS relapse receive high-dose methotrexate IV continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy administered during the induction, consolidation, intensification I, reinduction, intensification II, and maintenance phases of therapy as isolated CNS relapse patients.
All patients undergo neuropsychological assessment within 3 months after completion of induction therapy (before cranial radiotherapy) and at 2 years after completion of treatment.
Patients are followed for survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, TdT positive childhood acute lymphoblastic leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CNS Patients-Treatment (combination chemotherapy)
Arm Type
Experimental
Arm Description
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Arm Title
Testicular Relapse Patients (Combination chemotherapy)
Arm Type
Experimental
Arm Description
All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: MTX, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (MTX, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC 614629
Intervention Description
given subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
CYTOXAN, NSC #26271
Intervention Description
IV over 15-30 minutes
Intervention Type
Drug
Intervention Name(s)
cytarabine
Other Intervention Name(s)
Cytosine arabinoside, Ara-C, Cytosar, NSC #6387
Intervention Description
IV over 3 hours twice daily
Intervention Type
Drug
Intervention Name(s)
daunorubicin hydrochloride
Other Intervention Name(s)
Daunomycin, rubidomycin, Cerubidine, NSC #82151
Intervention Description
IV over 15 minutes
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Decadron, Hexadrol, Dexone, Dexameth, NSC #34521
Intervention Description
oral twice daily
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
VePesid, Etopophos, VP-16, NSC #141540
Intervention Description
IV over 1 hour
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Other Intervention Name(s)
LCV, Wellcovorin, citrovorum factor, folinic acid, NSC 03590
Intervention Description
rescue IV over 24 hours
Intervention Type
Drug
Intervention Name(s)
mercaptopurine
Other Intervention Name(s)
6-MP, Purinethol, 6-mercaptopurine, NSC #000755
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
methotrexate
Other Intervention Name(s)
MTX, amethopterin, Trexall, NSC #000740
Intervention Description
intramuscularly (IM)
Intervention Type
Drug
Intervention Name(s)
pegaspargase
Other Intervention Name(s)
PEG-asparaginase, PEGLA, PEG-L-asparaginase, polyethylene glycol-L-asparaginase, Oncaspar, NSC 624239
Intervention Description
intramuscularly (IM)
Intervention Type
Drug
Intervention Name(s)
therapeutic hydrocortisone
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
Intervention Description
Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.
Primary Outcome Measure Information:
Title
Event-free Survival
Description
Monitoring of efficacy results will be performed in comparison with historical results.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of acute lymphoblastic leukemia (ALL)
B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)
In first bone marrow remission (M1 by morphology) AND duration of first complete remission ≥ 18 months from time of initial diagnosis
First isolated CNS and/or testicular relapse
Isolated CNS relapse, as defined by 1 of the following:
WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin
Any number of WBC in CSF with immunophenotypic proof of leukemic relapse, defined by the following:
Identifiable blasts AND 1 of the following:
B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples obtained 4 weeks apart)
T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive CSF samples obtained 4 weeks apart) (Closed to accrual as of 05/20/10)
Isolated testicular relapse, defined as biopsy proven testicular involvement
No Down syndrome
No T-cell ALL or T-cell non-Hodgkin lymphoma
No known optic nerve and/or retinal involvement
PATIENT CHARACTERISTICS:
Age
18 months to 29 years at relapse
Performance status
Karnofsky 30-100% (for patients > 16 years of age) OR
Lansky 30-100% (for patients ≤ 16 years of age)
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Not specified
Renal
Creatinine adjusted according to age as follows:
No greater than 0.4 mg/dL (≤ 5 months)
No greater than 0.5 mg/dL (6 months -11 months)
No greater than 0.6 mg/dL (1 year-23 months)
No greater than 0.8 mg/dL (2 years-5 years)
No greater than 1.0 mg/dL (6 years-9 years)
No greater than 1.2 mg/dL (10 years-12 years)
No greater than 1.4 mg/dL (13 years and over [female])
No greater than 1.5 mg/dL (13 years to 15 years [male])
No greater than 1.7 mg/dL (16 years and over [male]) OR
Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular
Shortening fraction ≥ 27% by echocardiogram OR
Ejection fraction ≥ 50% by MUGA
Other
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior bone marrow transplantation
Chemotherapy
Prior total anthracycline dosage ≤ 360 mg/m^2
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Other
No prior systemic therapy for concurrent extramedullary relapse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio C. Barredo, MD
Organizational Affiliation
University of Miami Miller School of Medicine-Sylvester Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Caroline A. Hastings, MD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland
Official's Role
Study Chair
Facility Information:
Facility Name
UAB Comprehensive Cancer Center
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
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
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
90027
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 and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
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
Lucile Packard Children's Hospital at Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
95798
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Children's Hospital Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
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
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
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
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
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
Cardinal Bernardin Cancer Center at Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Keyser Family Cancer Center at Advocate Hope Children's Hospital
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Advocate Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
Facility Name
Simmons Cooper Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9677
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
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
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
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
CancerCare of Maine at Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
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
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
48109-0286
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
Butterworth Hospital at Spectrum Health
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
49007-5381
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
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
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
CCOP - Nevada Cancer Research Foundation
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
Overlook Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
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 Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Brooklyn Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201-5493
Country
United States
Facility Name
Maimonides Cancer Center at Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
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
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
11794-9446
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
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
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
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
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
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Dayton Children's - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
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 and Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Penn State Children's Hospital
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
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
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 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
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
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
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
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
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
05401
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States
Facility Name
Carilion Medical Center for Children at Roanoke Community Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
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
West Virginia University Health Sciences Center - Charleston
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
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
Gundersen Lutheran Center for Cancer and Blood
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
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
B3J 3G9
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 2V7
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
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
Starship Children's Health
City
Auckland
ZIP/Postal Code
1
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
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
Learn more about this trial
Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes
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