Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00096135
Collaborator
National Cancer Institute (NCI) (NIH)
168
153
2
1.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)
Study Start Date :
Nov 1, 2004
Actual Primary Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: CNS Patients-Treatment (combination chemotherapy)

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.

Biological: filgrastim
given subcutaneously (SC)
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC 614629
  • Drug: cyclophosphamide
    IV over 15-30 minutes
    Other Names:
  • CYTOXAN
  • NSC #26271
  • Drug: cytarabine
    IV over 3 hours twice daily
    Other Names:
  • Cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #6387
  • Drug: daunorubicin hydrochloride
    IV over 15 minutes
    Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
  • Drug: dexamethasone
    oral twice daily
    Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
  • Drug: etoposide
    IV over 1 hour
    Other Names:
  • VePesid
  • Etopophos
  • VP-16
  • NSC #141540
  • Drug: leucovorin calcium
    rescue IV over 24 hours
    Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC 03590
  • Drug: mercaptopurine
    oral
    Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
  • Drug: methotrexate
    intramuscularly (IM)
    Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #000740
  • Drug: pegaspargase
    intramuscularly (IM)
    Other Names:
  • PEG-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
  • Drug: therapeutic hydrocortisone

    Drug: vincristine sulfate
    given IV
    Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
  • Radiation: radiation therapy
    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.

    Experimental: Testicular Relapse Patients (Combination chemotherapy)

    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.

    Biological: filgrastim
    given subcutaneously (SC)
    Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC 614629
  • Drug: cyclophosphamide
    IV over 15-30 minutes
    Other Names:
  • CYTOXAN
  • NSC #26271
  • Drug: cytarabine
    IV over 3 hours twice daily
    Other Names:
  • Cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #6387
  • Drug: daunorubicin hydrochloride
    IV over 15 minutes
    Other Names:
  • Daunomycin
  • rubidomycin
  • Cerubidine
  • NSC #82151
  • Drug: dexamethasone
    oral twice daily
    Other Names:
  • Decadron
  • Hexadrol
  • Dexone
  • Dexameth
  • NSC #34521
  • Drug: etoposide
    IV over 1 hour
    Other Names:
  • VePesid
  • Etopophos
  • VP-16
  • NSC #141540
  • Drug: leucovorin calcium
    rescue IV over 24 hours
    Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC 03590
  • Drug: mercaptopurine
    oral
    Other Names:
  • 6-MP
  • Purinethol
  • 6-mercaptopurine
  • NSC #000755
  • Drug: methotrexate
    intramuscularly (IM)
    Other Names:
  • MTX
  • amethopterin
  • Trexall
  • NSC #000740
  • Drug: pegaspargase
    intramuscularly (IM)
    Other Names:
  • PEG-asparaginase
  • PEGLA
  • PEG-L-asparaginase
  • polyethylene glycol-L-asparaginase
  • Oncaspar
  • NSC 624239
  • Drug: therapeutic hydrocortisone

    Drug: vincristine sulfate
    given IV
    Other Names:
  • Oncovin
  • VCR
  • LCR
  • NSC #67574
  • Radiation: radiation therapy
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Event-free Survival [3 years]

      Monitoring of efficacy results will be performed in comparison with historical results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Months to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UAB Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 Phoenix Children's Hospital Phoenix Arizona United States 85016-7710
    3 Arizona Cancer Center at University of Arizona Health Sciences Center Tucson Arizona United States 85724-5024
    4 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    5 Southern California Permanente Medical Group Downey California United States 90027
    6 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    7 Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda California United States 92354
    8 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach California United States 90801
    9 Childrens Hospital Los Angeles Los Angeles California United States 90027
    10 Jonsson Comprehensive Cancer Center at UCLA Los Angeles California United States 90095-1781
    11 Children's Hospital Central California Madera California United States 93638-8762
    12 Children's Hospital and Research Center Oakland Oakland California United States 94609
    13 Children's Hospital of Orange County Orange California United States 92868
    14 Lucile Packard Children's Hospital at Stanford University Medical Center Palo Alto California United States 95798
    15 Sutter Cancer Center Sacramento California United States 95816
    16 Kaiser Permanente Medical Center - Oakland Sacramento California United States 95825
    17 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94115
    18 Children's Hospital Center for Cancer and Blood Disorders Aurora Colorado United States 80045
    19 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
    20 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    21 Alfred I. duPont Hospital for Children Wilmington Delaware United States 19803
    22 Children's National Medical Center Washington District of Columbia United States 20010-2970
    23 Broward General Medical Center Cancer Center Fort Lauderdale Florida United States 33316
    24 Lee Cancer Care of Lee Memorial Health System Fort Myers Florida United States 33901
    25 University of Florida Shands Cancer Center Gainesville Florida United States 32610-0232
    26 Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida United States 33021
    27 Nemours Children's Clinic Jacksonville Florida United States 32207
    28 University of Miami Sylvester Comprehensive Cancer Center - Miami Miami Florida United States 33136
    29 Miami Children's Hospital Miami Florida United States 33155
    30 Baptist-South Miami Regional Cancer Program Miami Florida United States 33176
    31 Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida United States 32803-1273
    32 M.D. Anderson Cancer Center at Orlando Orlando Florida United States 32806
    33 Nemours Children's Clinic - Orlando Orlando Florida United States 32806
    34 Sacred Heart Cancer Center at Sacred Heart Hospital Pensacola Florida United States 32504
    35 All Children's Hospital Saint Petersburg Florida United States 33701
    36 St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa Florida United States 33607
    37 Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach Florida United States 33407
    38 AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta Georgia United States 30322
    39 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    40 Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho United States 83712-6297
    41 University of Illinois Cancer Center Chicago Illinois United States 60612-7243
    42 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153
    43 Keyser Family Cancer Center at Advocate Hope Children's Hospital Oak Lawn Illinois United States 60453
    44 Advocate Lutheran General Cancer Care Center Park Ridge Illinois United States 60068-1174
    45 Simmons Cooper Cancer Institute Springfield Illinois United States 62794-9677
    46 Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202-5289
    47 St. Vincent Indianapolis Hospital Indianapolis Indiana United States 46260
    48 Blank Children's Hospital Des Moines Iowa United States 50309
    49 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242-1002
    50 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    51 Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky United States 40536-0093
    52 Kosair Children's Hospital Louisville Kentucky United States 40232
    53 CancerCare of Maine at Eastern Maine Medical Center Bangor Maine United States 04401
    54 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital Baltimore Maryland United States 21215
    55 Floating Hospital for Children at Tufts - New England Medical Center Boston Massachusetts United States 02111
    56 C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor Michigan United States 48109-0286
    57 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    58 Hurley Medical Center Flint Michigan United States 48503
    59 Butterworth Hospital at Spectrum Health Grand Rapids Michigan United States 49503-2560
    60 Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan United States 48236
    61 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-5381
    62 Breslin Cancer Center at Ingham Regional Medical Center Lansing Michigan United States 48910
    63 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    64 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    65 University of Mississippi Cancer Clinic Jackson Mississippi United States 39216-4505
    66 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
    67 Children's Mercy Hospital Kansas City Missouri United States 64108
    68 CCOP - Nevada Cancer Research Foundation Las Vegas Nevada United States 89109-2306
    69 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
    70 Hackensack University Medical Center Cancer Center Hackensack New Jersey United States 07601
    71 Overlook Hospital Morristown New Jersey United States 07962
    72 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    73 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
    74 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    75 St. Joseph's Hospital and Medical Center Paterson New Jersey United States 07503
    76 University of New Mexico Cancer Center Albuquerque New Mexico United States 87131-5636
    77 Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx New York United States 10461
    78 Brooklyn Hospital Center Brooklyn New York United States 11201-5493
    79 Maimonides Cancer Center at Maimonides Medical Center Brooklyn New York United States 11219
    80 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    81 Winthrop University Hospital Mineola New York United States 11501
    82 Schneider Children's Hospital New Hyde Park New York United States 11040
    83 NYU Cancer Institute at New York University Medical Center New York New York United States 10016
    84 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York New York United States 10032
    85 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
    86 Stony Brook University Cancer Center Stony Brook New York United States 11794-9446
    87 SUNY Upstate Medical University Hospital Syracuse New York United States 13210
    88 New York Medical College Valhalla New York United States 10595
    89 Blumenthal Cancer Center at Carolinas Medical Center Charlotte North Carolina United States 28232-2861
    90 Presbyterian Cancer Center at Presbyterian Hospital Charlotte North Carolina United States 28233-3549
    91 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    92 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
    93 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
    94 Akron Children's Hospital Akron Ohio United States 44308-1062
    95 Rainbow Babies and Children's Hospital Cleveland Ohio United States 44106-5000
    96 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    97 Nationwide Children's Hospital Columbus Ohio United States 43205-2696
    98 Dayton Children's - Dayton Dayton Ohio United States 45404-1815
    99 Medical University of Ohio Cancer Center Toledo Ohio United States 43614
    100 Tod Children's Hospital Youngstown Ohio United States 44501
    101 Oklahoma University Cancer Institute Oklahoma City Oklahoma United States 73104
    102 Legacy Emanuel Hospital and Health Center and Children's Hospital Portland Oregon United States 97227
    103 Knight Cancer Institute at Oregon Health and Science University Portland Oregon United States 97239-3098
    104 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
    105 Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania United States 17822-0001
    106 Penn State Children's Hospital Hershey Pennsylvania United States 17033-0850
    107 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104-9786
    108 St. Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134-1095
    109 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15213
    110 Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island United States 02903
    111 Hollings Cancer Center at Medical University of South Carolina Charleston South Carolina United States 29425
    112 Greenville Hospital Cancer Center Greenville South Carolina United States 29605
    113 Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota United States 57117-5039
    114 T.C. Thompson Children's Hospital Chattanooga Tennessee United States 37403
    115 East Tennessee Children's Hospital Knoxville Tennessee United States 37901
    116 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    117 Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo Texas United States 79106
    118 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    119 Medical City Dallas Hospital Dallas Texas United States 75230
    120 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas United States 75390
    121 Cook Children's Medical Center - Fort Worth Fort Worth Texas United States 76104
    122 Baylor University Medical Center - Houston Houston Texas United States 77030-2399
    123 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78207
    124 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229-3993
    125 Primary Children's Medical Center Salt Lake City Utah United States 84113-1100
    126 Fletcher Allen Health Care - University Health Center Campus Burlington Vermont United States 05401
    127 Inova Fairfax Hospital Falls Church Virginia United States 22042-3300
    128 Carilion Medical Center for Children at Roanoke Community Hospital Roanoke Virginia United States 24014
    129 Providence Cancer Center at Sacred Heart Medical Center Spokane Washington United States 99220-2555
    130 West Virginia University Health Sciences Center - Charleston Charleston West Virginia United States 25302
    131 Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown West Virginia United States 26506
    132 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
    133 Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin United States 54601
    134 Marshfield Clinic - Marshfield Center Marshfield Wisconsin United States 54449
    135 Midwest Children's Cancer Center at Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
    136 Princess Margaret Hospital for Children Perth Western Australia Australia 6001
    137 University of Alberta Hospital Edmonton Alberta Canada T6G 1Z2
    138 Children's & Women's Hospital of British Columbia Vancouver British Columbia Canada V6H 3V4
    139 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    140 Janeway Children's Health and Rehabilitation Centre St. John's Newfoundland and Labrador Canada A1B 3V6
    141 IWK Health Centre Halifax Nova Scotia Canada B3J 3G9
    142 McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario Canada L8N 3Z5
    143 Cancer Centre of Southeastern Ontario at Kingston General Hospital Kingston Ontario Canada K7L 2V7
    144 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    145 Hopital Sainte Justine Montreal Quebec Canada H3T 1C5
    146 Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan Canada S4T 7T1
    147 Saskatoon Cancer Centre at the University of Saskatchewan Saskatoon Saskatchewan Canada S7N 4H4
    148 Centre Hospitalier Universitaire de Quebec Quebec Canada G1V 4G2
    149 Starship Children's Health Auckland New Zealand 1
    150 Christchurch Hospital Christchurch New Zealand 8140
    151 Swiss Pediatric Oncology Group Bern Bern Switzerland 3010
    152 Swiss Pediatric Oncology Group Geneva Geneva Switzerland 1205
    153 Swiss Pediatric Oncology Group Lausanne Lausanne Switzerland 1011

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Julio C. Barredo, MD, University of Miami Miller School of Medicine-Sylvester Cancer Center
    • Study Chair: Caroline A. Hastings, MD, UCSF Benioff Children's Hospital Oakland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00096135
    Other Study ID Numbers:
    • AALL02P2
    • COG-AALL02P2
    • NCI-2011-01623
    First Posted:
    Nov 9, 2004
    Last Update Posted:
    Mar 21, 2017
    Last Verified:
    Feb 1, 2017

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
    Arm/Group Description All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
    Period Title: Overall Study
    STARTED 126 42
    COMPLETED 63 27
    NOT COMPLETED 63 15

    Baseline Characteristics

    Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy) Total
    Arm/Group Description All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. Total of all reporting groups
    Overall Participants 124 42 166
    Age (Count of Participants)
    <=18 years
    118
    95.2%
    42
    100%
    160
    96.4%
    Between 18 and 65 years
    6
    4.8%
    0
    0%
    6
    3.6%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    8.2
    (4.8)
    9.2
    (3.2)
    8.5
    (4.2)
    Sex: Female, Male (Count of Participants)
    Female
    36
    29%
    0
    0%
    36
    21.7%
    Male
    88
    71%
    42
    100%
    130
    78.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    33
    26.6%
    10
    23.8%
    43
    25.9%
    Not Hispanic or Latino
    87
    70.2%
    30
    71.4%
    117
    70.5%
    Unknown or Not Reported
    4
    3.2%
    2
    4.8%
    6
    3.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    8
    6.5%
    1
    2.4%
    9
    5.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    10
    8.1%
    2
    4.8%
    12
    7.2%
    White
    91
    73.4%
    33
    78.6%
    124
    74.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    15
    12.1%
    6
    14.3%
    21
    12.7%

    Outcome Measures

    1. Primary Outcome
    Title Event-free Survival
    Description Monitoring of efficacy results will be performed in comparison with historical results.
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.
    Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
    Arm/Group Description All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
    Measure Participants 120 40
    Number [percentage of participants]
    64.9
    52.3%
    70
    166.7%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. The 2 ineligible patients in the CNS group are not included in the adverse event reporting.
    Arm/Group Title CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
    Arm/Group Description All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT. All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
    All Cause Mortality
    CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/124 (5.6%) 1/42 (2.4%)
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation 1/124 (0.8%) 1 0/42 (0%) 0
    Cardiac disorders
    Cardiac disorders - Other 1/124 (0.8%) 1 0/42 (0%) 0
    General disorders
    Death NOS 1/124 (0.8%) 1 0/42 (0%) 0
    Hepatobiliary disorders
    Hepatic failure 1/124 (0.8%) 1 0/42 (0%) 0
    Infections and infestations
    Infections and infestations - Other 6/124 (4.8%) 7 1/42 (2.4%) 1
    Lung infection 1/124 (0.8%) 1 0/42 (0%) 0
    Investigations
    Activated partial thromboplastin time prolonged 1/124 (0.8%) 1 0/42 (0%) 0
    Alanine aminotransferase increased 1/124 (0.8%) 1 0/42 (0%) 0
    Aspartate aminotransferase increased 1/124 (0.8%) 1 0/42 (0%) 0
    Blood bilirubin increased 1/124 (0.8%) 1 0/42 (0%) 0
    Fibrinogen decreased 1/124 (0.8%) 1 0/42 (0%) 0
    GGT increased 1/124 (0.8%) 1 0/42 (0%) 0
    INR increased 1/124 (0.8%) 1 0/42 (0%) 0
    Platelet count decreased 1/124 (0.8%) 1 0/42 (0%) 0
    White blood cell decreased 1/124 (0.8%) 1 0/42 (0%) 0
    Metabolism and nutrition disorders
    Acidosis 1/124 (0.8%) 1 0/42 (0%) 0
    Hyperglycemia 1/124 (0.8%) 1 0/42 (0%) 0
    Hyponatremia 1/124 (0.8%) 1 0/42 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Adult respiratory distress syndrome 2/124 (1.6%) 2 0/42 (0%) 0
    Pneumonitis 2/124 (1.6%) 2 1/42 (2.4%) 1
    Vascular disorders
    Thromboembolic event 1/124 (0.8%) 1 0/42 (0%) 0
    Other (Not Including Serious) Adverse Events
    CNS Patients - Treatment (Combination Chemotherapy) Testicular Relapse Patients (Combination Chemotherapy)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 119/124 (96%) 41/42 (97.6%)
    Blood and lymphatic system disorders
    Anemia 52/124 (41.9%) 65 12/42 (28.6%) 15
    Blood and lymphatic system disorders - Other 2/124 (1.6%) 2 0/42 (0%) 0
    Disseminated intravascular coagulation 1/124 (0.8%) 1 0/42 (0%) 0
    Febrile neutropenia 81/124 (65.3%) 86 27/42 (64.3%) 30
    Cardiac disorders
    Sinus tachycardia 0/124 (0%) 0 1/42 (2.4%) 1
    Ear and labyrinth disorders
    Middle ear inflammation 3/124 (2.4%) 3 0/42 (0%) 0
    Eye disorders
    Extraocular muscle paresis 1/124 (0.8%) 1 0/42 (0%) 0
    Eye disorders - Other 1/124 (0.8%) 1 1/42 (2.4%) 1
    Photophobia 1/124 (0.8%) 1 0/42 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 7/124 (5.6%) 7 0/42 (0%) 0
    Anal mucositis 2/124 (1.6%) 2 0/42 (0%) 0
    Anal pain 1/124 (0.8%) 1 0/42 (0%) 0
    Colitis 2/124 (1.6%) 2 0/42 (0%) 0
    Constipation 1/124 (0.8%) 1 0/42 (0%) 0
    Diarrhea 12/124 (9.7%) 12 5/42 (11.9%) 5
    Dyspepsia 1/124 (0.8%) 1 0/42 (0%) 0
    Esophagitis 1/124 (0.8%) 1 0/42 (0%) 0
    Gastrointestinal disorders - Other 1/124 (0.8%) 1 0/42 (0%) 0
    Ileus 1/124 (0.8%) 1 0/42 (0%) 0
    Mucositis oral 15/124 (12.1%) 15 4/42 (9.5%) 4
    Nausea 7/124 (5.6%) 7 2/42 (4.8%) 2
    Oral pain 5/124 (4%) 5 1/42 (2.4%) 1
    Pancreatitis 4/124 (3.2%) 4 2/42 (4.8%) 3
    Rectal mucositis 0/124 (0%) 0 1/42 (2.4%) 1
    Rectal pain 3/124 (2.4%) 3 0/42 (0%) 0
    Stomach pain 1/124 (0.8%) 1 0/42 (0%) 0
    Typhlitis 0/124 (0%) 0 1/42 (2.4%) 1
    Vomiting 8/124 (6.5%) 8 0/42 (0%) 0
    General disorders
    Death NOS 0/124 (0%) 0 1/42 (2.4%) 1
    Fatigue 3/124 (2.4%) 3 0/42 (0%) 0
    Fever 13/124 (10.5%) 13 6/42 (14.3%) 6
    Flu like symptoms 2/124 (1.6%) 2 0/42 (0%) 0
    General disorders and administration site conditions - Other 3/124 (2.4%) 3 0/42 (0%) 0
    Multi-organ failure 1/124 (0.8%) 1 0/42 (0%) 0
    Pain 6/124 (4.8%) 6 1/42 (2.4%) 1
    Sudden death NOS 1/124 (0.8%) 1 0/42 (0%) 0
    Hepatobiliary disorders
    Hepatic failure 1/124 (0.8%) 1 0/42 (0%) 0
    Immune system disorders
    Allergic reaction 1/124 (0.8%) 1 1/42 (2.4%) 1
    Anaphylaxis 11/124 (8.9%) 11 7/42 (16.7%) 7
    Cytokine release syndrome 1/124 (0.8%) 1 1/42 (2.4%) 1
    Immune system disorders - Other 1/124 (0.8%) 1 0/42 (0%) 0
    Serum sickness 0/124 (0%) 0 1/42 (2.4%) 1
    Infections and infestations
    Abdominal infection 1/124 (0.8%) 1 0/42 (0%) 0
    Anorectal infection 2/124 (1.6%) 2 0/42 (0%) 0
    Arteritis infective 1/124 (0.8%) 1 0/42 (0%) 0
    Bladder infection 1/124 (0.8%) 1 0/42 (0%) 0
    Bronchial infection 0/124 (0%) 0 1/42 (2.4%) 1
    Catheter related infection 10/124 (8.1%) 10 3/42 (7.1%) 3
    Enterocolitis infectious 6/124 (4.8%) 6 0/42 (0%) 0
    Eye infection 1/124 (0.8%) 1 0/42 (0%) 0
    Gum infection 1/124 (0.8%) 1 0/42 (0%) 0
    Infections and infestations - Other 82/124 (66.1%) 90 23/42 (54.8%) 25
    Joint infection 1/124 (0.8%) 1 0/42 (0%) 0
    Lung infection 10/124 (8.1%) 10 2/42 (4.8%) 2
    Meningitis 2/124 (1.6%) 2 0/42 (0%) 0
    Mucosal infection 2/124 (1.6%) 2 0/42 (0%) 0
    Otitis externa 4/124 (3.2%) 4 0/42 (0%) 0
    Otitis media 1/124 (0.8%) 1 0/42 (0%) 0
    Penile infection 1/124 (0.8%) 1 0/42 (0%) 0
    Pharyngitis 2/124 (1.6%) 2 0/42 (0%) 0
    Salivary gland infection 1/124 (0.8%) 1 0/42 (0%) 0
    Sepsis 4/124 (3.2%) 4 1/42 (2.4%) 1
    Sinusitis 2/124 (1.6%) 2 1/42 (2.4%) 1
    Skin infection 4/124 (3.2%) 4 2/42 (4.8%) 2
    Small intestine infection 1/124 (0.8%) 1 1/42 (2.4%) 1
    Upper respiratory infection 4/124 (3.2%) 4 2/42 (4.8%) 2
    Urinary tract infection 7/124 (5.6%) 7 1/42 (2.4%) 1
    Wound infection 3/124 (2.4%) 3 0/42 (0%) 0
    Injury, poisoning and procedural complications
    Dermatitis radiation 0/124 (0%) 0 2/42 (4.8%) 2
    Fracture 1/124 (0.8%) 1 0/42 (0%) 0
    Intraoperative venous injury 1/124 (0.8%) 1 0/42 (0%) 0
    Investigations
    Activated partial thromboplastin time prolonged 4/124 (3.2%) 4 0/42 (0%) 0
    Alanine aminotransferase increased 64/124 (51.6%) 71 12/42 (28.6%) 14
    Alkaline phosphatase increased 1/124 (0.8%) 1 0/42 (0%) 0
    Aspartate aminotransferase increased 35/124 (28.2%) 35 4/42 (9.5%) 5
    Blood bilirubin increased 7/124 (5.6%) 7 1/42 (2.4%) 1
    Cholesterol high 2/124 (1.6%) 2 0/42 (0%) 0
    Creatinine increased 2/124 (1.6%) 2 0/42 (0%) 0
    Electrocardiogram QT corrected interval prolonged 0/124 (0%) 0 1/42 (2.4%) 1
    Fibrinogen decreased 1/124 (0.8%) 1 1/42 (2.4%) 1
    GGT increased 6/124 (4.8%) 6 0/42 (0%) 0
    Investigations - Other 1/124 (0.8%) 1 0/42 (0%) 0
    Lipase increased 9/124 (7.3%) 10 1/42 (2.4%) 1
    Lymphocyte count decreased 3/124 (2.4%) 5 1/42 (2.4%) 2
    Neutrophil count decreased 98/124 (79%) 130 33/42 (78.6%) 42
    Platelet count decreased 73/124 (58.9%) 97 16/42 (38.1%) 23
    Serum amylase increased 4/124 (3.2%) 4 0/42 (0%) 0
    Weight gain 2/124 (1.6%) 2 1/42 (2.4%) 1
    White blood cell decreased 63/124 (50.8%) 93 14/42 (33.3%) 19
    Metabolism and nutrition disorders
    Anorexia 5/124 (4%) 5 3/42 (7.1%) 3
    Dehydration 8/124 (6.5%) 8 6/42 (14.3%) 6
    Glucose intolerance 1/124 (0.8%) 1 0/42 (0%) 0
    Hyperglycemia 9/124 (7.3%) 9 5/42 (11.9%) 7
    Hyperkalemia 1/124 (0.8%) 1 0/42 (0%) 0
    Hypertriglyceridemia 2/124 (1.6%) 2 1/42 (2.4%) 1
    Hypoalbuminemia 3/124 (2.4%) 3 0/42 (0%) 0
    Hypocalcemia 6/124 (4.8%) 6 0/42 (0%) 0
    Hypoglycemia 1/124 (0.8%) 1 0/42 (0%) 0
    Hypokalemia 30/124 (24.2%) 35 9/42 (21.4%) 9
    Hypomagnesemia 1/124 (0.8%) 1 0/42 (0%) 0
    Hyponatremia 12/124 (9.7%) 12 3/42 (7.1%) 3
    Hypophosphatemia 4/124 (3.2%) 4 1/42 (2.4%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/124 (0.8%) 1 0/42 (0%) 0
    Avascular necrosis 3/124 (2.4%) 3 0/42 (0%) 0
    Back pain 6/124 (4.8%) 6 0/42 (0%) 0
    Bone pain 3/124 (2.4%) 3 1/42 (2.4%) 1
    Muscle weakness lower limb 1/124 (0.8%) 1 0/42 (0%) 0
    Musculoskeletal and connective tissue disorder - Other 1/124 (0.8%) 1 0/42 (0%) 0
    Myalgia 2/124 (1.6%) 2 0/42 (0%) 0
    Myositis 1/124 (0.8%) 1 0/42 (0%) 0
    Neck pain 0/124 (0%) 0 1/42 (2.4%) 1
    Pain in extremity 5/124 (4%) 5 3/42 (7.1%) 3
    Nervous system disorders
    Ataxia 1/124 (0.8%) 1 0/42 (0%) 0
    Cognitive disturbance 1/124 (0.8%) 1 0/42 (0%) 0
    Depressed level of consciousness 1/124 (0.8%) 1 0/42 (0%) 0
    Dizziness 1/124 (0.8%) 1 1/42 (2.4%) 1
    Dysphasia 1/124 (0.8%) 1 0/42 (0%) 0
    Headache 7/124 (5.6%) 7 0/42 (0%) 0
    Memory impairment 1/124 (0.8%) 1 0/42 (0%) 0
    Neuralgia 1/124 (0.8%) 1 0/42 (0%) 0
    Peripheral motor neuropathy 9/124 (7.3%) 9 2/42 (4.8%) 2
    Peripheral sensory neuropathy 8/124 (6.5%) 8 3/42 (7.1%) 3
    Seizure 2/124 (1.6%) 2 0/42 (0%) 0
    Sinus pain 1/124 (0.8%) 1 0/42 (0%) 0
    Syncope 1/124 (0.8%) 1 0/42 (0%) 0
    Psychiatric disorders
    Agitation 1/124 (0.8%) 1 1/42 (2.4%) 1
    Anxiety 1/124 (0.8%) 1 0/42 (0%) 0
    Confusion 1/124 (0.8%) 1 0/42 (0%) 0
    Depression 2/124 (1.6%) 2 0/42 (0%) 0
    Insomnia 1/124 (0.8%) 1 0/42 (0%) 0
    Personality change 2/124 (1.6%) 2 1/42 (2.4%) 1
    Psychosis 1/124 (0.8%) 1 0/42 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 2/124 (1.6%) 2 0/42 (0%) 0
    Proteinuria 1/124 (0.8%) 1 0/42 (0%) 0
    Renal calculi 0/124 (0%) 0 1/42 (2.4%) 1
    Urinary tract obstruction 1/124 (0.8%) 1 0/42 (0%) 0
    Urinary tract pain 1/124 (0.8%) 1 0/42 (0%) 0
    Reproductive system and breast disorders
    Penile pain 1/124 (0.8%) 1 0/42 (0%) 0
    Perineal pain 1/124 (0.8%) 1 0/42 (0%) 0
    Vaginal inflammation 1/124 (0.8%) 1 0/42 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Apnea 0/124 (0%) 0 1/42 (2.4%) 1
    Bronchopulmonary hemorrhage 1/124 (0.8%) 1 0/42 (0%) 0
    Cough 4/124 (3.2%) 4 0/42 (0%) 0
    Dyspnea 0/124 (0%) 0 1/42 (2.4%) 1
    Epistaxis 3/124 (2.4%) 3 0/42 (0%) 0
    Hiccups 1/124 (0.8%) 1 0/42 (0%) 0
    Hypoxia 4/124 (3.2%) 4 1/42 (2.4%) 1
    Pharyngeal mucositis 1/124 (0.8%) 1 0/42 (0%) 0
    Pharyngolaryngeal pain 1/124 (0.8%) 1 0/42 (0%) 0
    Pneumonitis 7/124 (5.6%) 7 2/42 (4.8%) 2
    Respiratory, thoracic and mediastinal disorders - Other 3/124 (2.4%) 3 0/42 (0%) 0
    Skin and subcutaneous tissue disorders
    Pain of skin 1/124 (0.8%) 1 1/42 (2.4%) 1
    Purpura 1/124 (0.8%) 1 0/42 (0%) 0
    Rash acneiform 1/124 (0.8%) 1 0/42 (0%) 0
    Rash maculo-papular 1/124 (0.8%) 1 0/42 (0%) 0
    Skin and subcutaneous tissue disorders - Other 2/124 (1.6%) 2 0/42 (0%) 0
    Vascular disorders
    Capillary leak syndrome 0/124 (0%) 0 1/42 (2.4%) 1
    Hypertension 2/124 (1.6%) 2 0/42 (0%) 0
    Hypotension 4/124 (3.2%) 4 3/42 (7.1%) 3
    Thromboembolic event 1/124 (0.8%) 1 3/42 (7.1%) 3
    Vascular disorders - Other 1/124 (0.8%) 1 0/42 (0%) 0

    Limitations/Caveats

    The COG SDC reviewed the NLM notification related to ct.gov AE/SAE reporting. The information in 'Additional Description' is accurate with respect to data supplied to ct.gov.COG plans to submit data AE/SAE data consistent with the text in this field.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Must obtain prior sponsor approval.

    Results Point of Contact

    Name/Title Results Reporting Coordinator
    Organization Children's Oncology Group
    Phone 626-447-0064
    Email resultsreportingcoordinator@childrensoncologygroup.org
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00096135
    Other Study ID Numbers:
    • AALL02P2
    • COG-AALL02P2
    • NCI-2011-01623
    First Posted:
    Nov 9, 2004
    Last Update Posted:
    Mar 21, 2017
    Last Verified:
    Feb 1, 2017