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Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01817075
Collaborator
National Cancer Institute (NCI) (NIH)
177
Enrollment
59
Locations
2
Arms
76.8
Actual Duration (Months)
3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it works compared to control cleansing in preventing central line associated bloodstream infection and acquisition of multi-drug resistant organisms in younger patients with cancer or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream infections and bacterial infections associated with the central line.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Chlorhexidine Gluconate Skin Cleanser
  • Other: Laboratory Biomarker Analysis
  • Procedure: Mild Soap Skin Cleanser
  • Other: Questionnaire Administration
 Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine whether chlorhexidine gluconate (CHG) cleansing decreases central line associated bloodstream infection (CLABSI) in children with cancer or those receiving an allogeneic hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVES:

  1. To determine whether CHG cleansing decreases acquisition of multi-drug resistant organisms (MDRO: vancomycin resistant enterococci [VRE], methicillin resistant Staphylococcus aureus [MRSA], etc.) in children with cancer or those receiving allogeneic HCT.

  2. To determine whether CHG cleansing in children with cancer or those receiving allogeneic HCT is associated with cutaneous bacterial isolates with reduced susceptibility to CHG.

  3. To determine whether CHG cleansing decreases positive blood cultures in children with cancer or those receiving allogeneic HCT.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD) for 90 days.

ARM II: Patients receive control cleansing with topical skin wipes QD for 90 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
177 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Impact of Cleansing With Chlorhexidine Gluconate (CHG) on Reducing Central Line Associated Bloodstream Infection (CLABSI) and Acquisition of Multi-drug Resistant Organisms (MDRO) in Children With Cancer or Those Receiving Allogeneic Hematopoietic Cell Transplantation (HCT)
Actual Study Start Date :
Nov 4, 2013
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (CHG cleansing wipe)

Patients receive CHG cleansing with topical skin wipes QD for 90 days.

Procedure: Chlorhexidine Gluconate Skin Cleanser
Given CHG cleansing
Other Names:
  • Skin Cleanser with Chlorhexidine Gluconate

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Other: Questionnaire Administration
    Ancillary studies
    Active Comparator: Arm II (control)

    Patients receive control cleansing with topical skin wipes QD for 90 days.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Procedure: Mild Soap Skin Cleanser
    Given control cleansing
    Other Names:
  • Skin Cleanser with Mild Soap

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days [Up to 90 days post enrollment date]

      Rate of CLABSI per 1000 at-risk days. CLABSI outcome is defined according to the January 2015 Centers for Disease Control and Prevention (CDC) criteria. At risk days are defined as days with eligible central lines in place.

    Secondary Outcome Measures

    1. Percentage of Patients With Multi-drug Resistant Organisms (MDRO) [Up to 90 days post enrollment date]

      MDROs are defined as Staphylococcus aureus resistant to oxacillin, Enterococcus spp. resistant to vancomycin, Klebsiella pneumoniae or Escherichia coli non-susceptible (intermediate or resistant) to ceftriaxone, ceftazidime, cefepime or any carbapenem, and Pseudomonas aeruginosa or Acinetobacter baumannii resistant to any carbapenem or ceftazidime, and either an aminoglycoside or fluoroquinolone. Clostridium difficile infection (CDI) is included as an MDRO and is defined as a positive lab test for C. difficile and > 3 unformed stools in < 24 hours.

    2. Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG) [Up to 90 days post enrollment date]

      Susceptibility to CHG is defined by MIC cutoff that is cutaneous staphylococcal isolate isolated from a follow-up swab with CHG MIC > 4 ug/mL in patient without a resistant staphylococcal isolate isolated from a baseline swab.

    3. Rate of Bacteremia Per 1000 At-risk Days [Up to 90 days post enrollment date]

      A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • TRANSPLANT PATIENTS: all patients undergoing planned allogeneic transplant (both malignant and non-malignant diagnoses)

    • ONCOLOGY PATIENTS: patients with an oncology diagnosis that are or will be on a chemotherapy regimen that will last for an additional >= 3 months or are on or will be on a chemotherapy regimen for < 3 months and then proceed to transplant (allogeneic or autologous stem cell rescue) during the 3-month study period

    • Patients undergoing allogeneic transplant must have, or be scheduled to have, an external tunneled central venous catheter (CVC) (Broviacs, Hickmans, tunneled percutaneously inserted central catheter [PICCs], etc.) and/or non-tunneled percutaneously inserted central catheter (PICC) that is expected to remain in place for an additional >= 3 months

    • Patients with acute myelogenous leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL) that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) and/or non-tunneled PICC that is expected to remain in place for an additional >= 3 months

    • All other oncology patients that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) that is expected to remain in place for an additional >= 3 months

    • All patients and/or their parents or legal guardians must sign a written informed consent

    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

    Exclusion Criteria:

    • Patients with a previous or current line infection are ineligible until 14 days after the completion of antibiotics

    • Patients with only totally implanted CVCs or ports are ineligible

    • Patients with a known allergy or hypersensitivity to CHG are ineligible

    • Patients with chronic, severe, generalized skin breakdown (such as generalized blistering, burns, severe graft versus host disease [GVHD] with open sores, etc.) are ineligible

    • Patients currently enrolled on Children's Oncology Group (COG) study ACCL0934 are not eligible until they have completed the infection observation period of that study

    • Patients scheduled to receive broad-spectrum prophylactic antibacterial therapy are ineligible; patients only receiving prophylaxis for Pneumocystis pneumonia (PCP) (trimethoprim [TMP]/sulfamethoxazole [SMX]) or encapsulated organisms (penicillin) are eligible

    • Patients receiving sorafenib at the time of enrollment and those who are scheduled to receive sorafenib as part of a treatment plan are ineligible

    • Patients using prophylactic antimicrobial locks in the CVC at the time of enrollment and those who are scheduled to receive antimicrobial locks in the CVC as part of a treatment plan are ineligible

    • Patients previously enrolled on this trial are ineligible

    • Females who are pregnant or breastfeeding are ineligible

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    2 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    3 Children's Hospital Los Angeles Los Angeles California United States 90027
    4 Valley Children's Hospital Madera California United States 93636
    5 Children's Hospital and Research Center at Oakland Oakland California United States 94609-1809
    6 Children's Hospital of Orange County Orange California United States 92868
    7 UCSF Medical Center-Parnassus San Francisco California United States 94143
    8 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    9 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
    10 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    11 Yale University New Haven Connecticut United States 06520
    12 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    13 Children's National Medical Center Washington District of Columbia United States 20010
    14 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    15 Nemours Children's Hospital Orlando Florida United States 32827
    16 Nemours Children's Clinic - Pensacola Pensacola Florida United States 32504
    17 Johns Hopkins All Children's Hospital Saint Petersburg Florida United States 33701
    18 Tampa General Hospital Tampa Florida United States 33606
    19 Children's Healthcare of Atlanta - Egleston Atlanta Georgia United States 30322
    20 University of Illinois Chicago Illinois United States 60612
    21 Children's Hospital New Orleans New Orleans Louisiana United States 70118
    22 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    23 Eastern Maine Medical Center Bangor Maine United States 04401
    24 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    25 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    26 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    27 Wayne State University/Karmanos Cancer Institute Detroit Michigan United States 48201
    28 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
    29 Washington University School of Medicine Saint Louis Missouri United States 63110
    30 Hackensack University Medical Center Hackensack New Jersey United States 07601
    31 Montefiore Medical Center - Moses Campus Bronx New York United States 10467
    32 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    33 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    34 New York Medical College Valhalla New York United States 10595
    35 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    36 The Toledo Hospital/Toledo Children's Hospital Toledo Ohio United States 43606
    37 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    38 Oregon Health and Science University Portland Oregon United States 97239
    39 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    40 T C Thompson Children's Hospital Chattanooga Tennessee United States 37403
    41 St. Jude Children's Research Hospital Memphis Tennessee United States 38105
    42 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    43 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    44 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    45 Cook Children's Medical Center Fort Worth Texas United States 76104
    46 Children's Hospital of San Antonio San Antonio Texas United States 78207
    47 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    48 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    49 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    50 Seattle Children's Hospital Seattle Washington United States 98105
    51 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    52 Madigan Army Medical Center Tacoma Washington United States 98431
    53 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    54 Children's Hospital London Ontario Canada N6A 5W9
    55 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    56 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    57 The Montreal Children's Hospital of the MUHC Montreal Quebec Canada H3H 1P3
    58 San Jorge Children's Hospital San Juan Puerto Rico 00912
    59 University Pediatric Hospital San Juan Puerto Rico 00926

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Danielle M Zerr, Children's Oncology Group

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01817075
    Other Study ID Numbers:
    • ACCL1034
    • NCI-2013-00595
    • ACCL1034
    • COG-ACCL1034
    • ACCL1034
    • R01CA163394
    • U10CA095861
    • UG1CA189955
    First Posted:
    Mar 22, 2013
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    Mar 1, 2020
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Bacterial Infections
    Sepsis
    Staphylococcal Infections
    Leukemia
    Neoplasms
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Recurrence
    Chlorhexidine
    Chlorhexidine gluconate

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm I (CHG Cleansing Wipe) Arm II (Control)
    Arm/Group Description Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
    Period Title: Overall Study
    STARTED 88 89
    COMPLETED 41 54
    NOT COMPLETED 47 35

    Baseline Characteristics

    Arm/Group Title Arm I (CHG Cleansing Wipe) Arm II (Control) Total
    Arm/Group Description Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies Total of all reporting groups
    Overall Participants 88 89 177
    Age (Count of Participants)
    <=18 years
    83
    94.3%
    88
    98.9%
    171
    96.6%
    Between 18 and 65 years
    5
    5.7%
    1
    1.1%
    6
    3.4%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    7.4
    (5.8)
    5
    (4.8)
    6.2
    (5.4)
    Sex: Female, Male (Count of Participants)
    Female
    35
    39.8%
    36
    40.4%
    71
    40.1%
    Male
    53
    60.2%
    53
    59.6%
    106
    59.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    16
    18.2%
    20
    22.5%
    36
    20.3%
    Not Hispanic or Latino
    69
    78.4%
    63
    70.8%
    132
    74.6%
    Unknown or Not Reported
    3
    3.4%
    6
    6.7%
    9
    5.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    6
    6.8%
    5
    5.6%
    11
    6.2%
    Native Hawaiian or Other Pacific Islander
    2
    2.3%
    0
    0%
    2
    1.1%
    Black or African American
    14
    15.9%
    9
    10.1%
    23
    13%
    White
    51
    58%
    54
    60.7%
    105
    59.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    15
    17%
    21
    23.6%
    36
    20.3%
    Region of Enrollment (participants) [Number]
    United States
    77
    87.5%
    82
    92.1%
    159
    89.8%
    Canada
    11
    12.5%
    7
    7.9%
    18
    10.2%

    Outcome Measures

    1. Primary Outcome
    Title Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days
    Description Rate of CLABSI per 1000 at-risk days. CLABSI outcome is defined according to the January 2015 Centers for Disease Control and Prevention (CDC) criteria. At risk days are defined as days with eligible central lines in place.
    Time Frame Up to 90 days post enrollment date

    Outcome Measure Data

    Analysis Population Description
    3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.
    Arm/Group Title Arm I (CHG Cleansing Wipe) Arm II (Control)
    Arm/Group Description Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
    Measure Participants 88 86
    Number (95% Confidence Interval) [CLABSI per 1000 at-risk days.]
    5.44
    3.1
    2. Secondary Outcome
    Title Percentage of Patients With Multi-drug Resistant Organisms (MDRO)
    Description MDROs are defined as Staphylococcus aureus resistant to oxacillin, Enterococcus spp. resistant to vancomycin, Klebsiella pneumoniae or Escherichia coli non-susceptible (intermediate or resistant) to ceftriaxone, ceftazidime, cefepime or any carbapenem, and Pseudomonas aeruginosa or Acinetobacter baumannii resistant to any carbapenem or ceftazidime, and either an aminoglycoside or fluoroquinolone. Clostridium difficile infection (CDI) is included as an MDRO and is defined as a positive lab test for C. difficile and > 3 unformed stools in < 24 hours.
    Time Frame Up to 90 days post enrollment date

    Outcome Measure Data

    Analysis Population Description
    3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.
    Arm/Group Title Arm I (CHG Cleansing Wipe) Arm II (Control)
    Arm/Group Description Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
    Measure Participants 88 86
    Number [Percentage of patients]
    15
    12
    3. Secondary Outcome
    Title Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG)
    Description Susceptibility to CHG is defined by MIC cutoff that is cutaneous staphylococcal isolate isolated from a follow-up swab with CHG MIC > 4 ug/mL in patient without a resistant staphylococcal isolate isolated from a baseline swab.
    Time Frame Up to 90 days post enrollment date

    Outcome Measure Data

    Analysis Population Description
    135 participants contributed a baseline and at least one follow-up swab and were included in this analysis
    Arm/Group Title Arm I (CHG Cleansing Wipe) Arm II (Control)
    Arm/Group Description Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
    Measure Participants 62 73
    Number [percentage of patients]
    17.7
    5.5
    4. Secondary Outcome
    Title Rate of Bacteremia Per 1000 At-risk Days
    Description A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.
    Time Frame Up to 90 days post enrollment date

    Outcome Measure Data

    Analysis Population Description
    3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analysis.
    Arm/Group Title Arm I (CHG Cleansing Wipe) Arm II (Control)
    Arm/Group Description Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
    Measure Participants 88 86
    Number (95% Confidence Interval) [bacteremia per 1000 at-risk days]
    7.24
    4.93

    Adverse Events

    Time Frame Collected Adverse Events within the 90 day observation period
    Adverse Event Reporting Description Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible and unevaluable (withdraw of consent) patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    Arm/Group Title Arm I (CHG Cleansing Wipe) Arm II (Control)
    Arm/Group Description Patients receive CHG cleansing with topical skin wipes QD for 90 days. Chlorhexidine Gluconate Skin Cleanser: Given CHG cleansing Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Patients receive control cleansing with topical skin wipes QD for 90 days. Laboratory Biomarker Analysis: Correlative studies Mild Soap Skin Cleanser: Given control cleansing Questionnaire Administration: Ancillary studies
    All Cause Mortality
    Arm I (CHG Cleansing Wipe) Arm II (Control)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/88 (1.1%) 3/86 (3.5%)
    Serious Adverse Events
    Arm I (CHG Cleansing Wipe) Arm II (Control)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/88 (0%) 2/86 (2.3%)
    Cardiac disorders
    Cardiac arrest 0/88 (0%) 1/86 (1.2%)
    General disorders
    Multi-organ failure 0/88 (0%) 1/86 (1.2%)
    Other (Not Including Serious) Adverse Events
    Arm I (CHG Cleansing Wipe) Arm II (Control)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 22/88 (25%) 14/86 (16.3%)
    Gastrointestinal disorders
    Mucositis oral 1/88 (1.1%) 0/86 (0%)
    Infections and infestations
    Sepsis 1/88 (1.1%) 0/86 (0%)
    Metabolism and nutrition disorders
    Hypercalcemia 0/88 (0%) 1/86 (1.2%)
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 11/88 (12.5%) 7/86 (8.1%)
    Skin and subcutaneous tissue disorders - Other, specify 9/88 (10.2%) 4/86 (4.7%)
    Skin ulceration 1/88 (1.1%) 0/86 (0%)
    Urticaria 1/88 (1.1%) 3/86 (3.5%)

    Limitations/Caveats

    [Not Specified]

    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:
    NCT01817075
    Other Study ID Numbers:
    • ACCL1034
    • NCI-2013-00595
    • ACCL1034
    • COG-ACCL1034
    • ACCL1034
    • R01CA163394
    • U10CA095861
    • UG1CA189955
    First Posted:
    Mar 22, 2013
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    Mar 1, 2020