Hybrid Immunotherapy for Hemophagocytic LymphoHistiocytosis

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT01104025
Collaborator
(none)
31
15
1
72
2.1
0

Study Details

Study Description

Brief Summary

Despite good progress during the last decade, hemophagocytic lymphohistiocytosis (HLH) remains difficult to treat. Two different treatment regimens have been used successfully. The first one, a treatment regimen based on two drugs called etoposide and dexamethasone, has been used worldwide. The second regimen, based on two drugs called Anti-thymocyte globulin (ATG) and prednisone, has been used mostly at one hospital in Paris, for over 15 years. With either regimen, about three quarters of treated children survive the most difficult time, the first two months after diagnosis. These two different regimens appear to work somewhat differently, and we suspect that combining them may give better results than either regimen alone. We are conducting this clinical trial to test the combination of ATG, dexamethasone, and etoposide for the treatment of HLH.

The purpose of this research study is to find out what effects (good and bad) this drug combination has on you and your HLH.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Hemophagocytic lymphohistiocytosis (HLH) is a rare immunological disorder first recognized almost 70 years ago.(1) Genetic and animal studies have indicated that the familial form of HLH is clearly due to a deficiency of cytotoxic killing. Patients with HLH present with a potentially fatal syndrome of 'hyperimmunity.' These patients have severe inflammation, associated with cytopenias and variably severe bone marrow, liver, or CNS damage. Tissue damage and mortality appear to be due to hypercytokinemia related to persistent immune hyperactivation. An animal model of HLH and correlative human studies all suggest that excessive and abnormal activation of T cells drives the pathophysiology of this disorder, and that suppressing this excessive activation is critical for successful therapy of HLH. It is believed a combination of the two proven induction regimens for hemophagocytic lymphohistiocytosis (HLH) (anti-thymocyte globulin (ATG)- and etoposide-based) will result in response rates and overall survival rates at eight weeks which are comparable or better than the current standard of care (induction therapy per the HLH-94 protocol).

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Phase II Pilot Study of Hybrid ImmunoTherapy(ATG/Dexamethasone/Etoposide) for Hemophagocytic LymphoHistiocytosis:HIT-HLH
Study Start Date :
Apr 1, 2010
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Induction Therapy

ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42

Drug: ATG, rabbit
ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours).
Other Names:
  • Thymoglobulin
  • Drug: Etoposide
    Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses.
    Other Names:
  • Etopophos
  • Toposar
  • VePesid
  • Drug: Methotrexate
    Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients (CNS+ patients are those patients which have any of the following: elevated CSF (cerebral spinal fluid) protein or white count, seizures, focal or global neurologic deficit, MRI abnormalities consistent with CNS involvement by HLH.) in the following doses: age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg. It will be administered (+/- 3 days) on day 7, 14, 21 and 42.

    Drug: hydrocortisone
    Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients (CNS+ patients are those patients which have any of the following: elevated CSF (cerebral spinal fluid) protein or white count, seizures, focal or global neurologic deficit, MRI abnormalities consistent with CNS involvement by HLH.) in the following doses: age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg. It will be administered (+/- 3 days) on day 7, 14, 21 and 42.

    Drug: Dexamethasone
    will be started with the ATG. It will be divided BID, given IV for at least 1 week before switching to PO. Dosing: 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [8 Weeks]

      To determine the overall survival of patients with hemophagocytic lymphohistiocytosis at 8 weeks after an ATG/etoposide-based induction regimen and to determine the feasibility of this approach in the context of a multicenter clinical trial.

    Secondary Outcome Measures

    1. Time to Response [8 Weeks]

      To determine the median time to complete response during 8 weeks of therapy

    2. Overall Survival [up to day 180]

      To determine overall survival prior to the initiation of BMT (bone marrow transplant) preparative regimen (or day 180, if BMT preparative regimen not yet begun)

    3. Number of Participants Who Experienced Reactivation [up to 180 days]

      To determine the frequency of disease reactivation prior to initiation of BMT preparative regimen (or day 180, if BMT preparative regimen not yet begun)

    4. Overall Survival to Day +100 [up to day 280]

      To determine overall survival to day +100 after BMT, for patients who have undergone BMT within 6 months of study entry

    5. Disease Status at BMT [up to day 180]

      To determine the rate of complete response at the time of BMT preparative regimen initiation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • diagnosis of hemophagocytic lymphohistiocytosis

    • Patients <18 years of age

    • The patient must have active disease at the time of enrollment

    • Patient's legal guardians must sign an Institutional Review Board approved consent form indicating their awareness of the investigational nature and the risks of this study.

    • Eligible subjects must be enrolled with the protocol coordinating center

    Exclusion Criteria:
    • Recent treatment, within 3 months, with another therapeutic regimen for HLH

    • Known active malignancy

    • Known rheumatologic diagnosis which may be the underlying cause of HLH

    • Pregnancy (as determined by serum or urine test) or active breast feeding

    • Failure to provide signed informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Children's Hospital Phoenix Arizona United States 85254
    2 University of California, San Francisco Department of Pediatrics San Francisco California United States 94143
    3 Stanford University Stanford California United States 94305
    4 University of Colorado Aurora Colorado United States 80045
    5 Nemours Wilmington Delaware United States 19803
    6 Children's National Medical Center Washington District of Columbia United States 20010
    7 Nemours Jacksonville Florida United States 32827
    8 Florida All Children's Hospital Saint Petersburg Florida United States 33701
    9 Tulane University Medical Center New Orleans Louisiana United States 70118
    10 Children's Hospital Boston Boston Massachusetts United States 02115
    11 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    12 Oregon Health and Science University Portland Oregon United States 21703
    13 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19145
    14 Texas Children's Cancer Center/Baylor College of Medicine Houston Texas United States 77030
    15 The Hospital for Sick Children Toronto Ontario Canada

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Principal Investigator: Michael Jordan, MD, Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01104025
    Other Study ID Numbers:
    • HIT-HLH
    First Posted:
    Apr 15, 2010
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2020

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients.
    Period Title: Treatment Period
    STARTED 31
    COMPLETED 25
    NOT COMPLETED 6
    Period Title: Treatment Period
    STARTED 25
    COMPLETED 22
    NOT COMPLETED 3
    Period Title: Treatment Period
    STARTED 11
    COMPLETED 9
    NOT COMPLETED 2

    Baseline Characteristics

    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    Overall Participants 31
    Age (Count of Participants)
    <=18 years
    31
    100%
    Between 18 and 65 years
    0
    0%
    >=65 years
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    13
    41.9%
    Male
    18
    58.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    6.5%
    Asian
    3
    9.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    1
    3.2%
    White
    25
    80.6%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    Canada
    1
    3.2%
    United States
    30
    96.8%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival
    Description To determine the overall survival of patients with hemophagocytic lymphohistiocytosis at 8 weeks after an ATG/etoposide-based induction regimen and to determine the feasibility of this approach in the context of a multicenter clinical trial.
    Time Frame 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    Measure Participants 31
    Count of Participants [Participants]
    25
    80.6%
    2. Secondary Outcome
    Title Time to Response
    Description To determine the median time to complete response during 8 weeks of therapy
    Time Frame 8 Weeks

    Outcome Measure Data

    Analysis Population Description
    Patients assessed for disease features and classified each week per definition of complete response in order to determine the time at which they achieved complete response.
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    Measure Participants 11
    Median (Full Range) [weeks]
    4
    3. Secondary Outcome
    Title Overall Survival
    Description To determine overall survival prior to the initiation of BMT (bone marrow transplant) preparative regimen (or day 180, if BMT preparative regimen not yet begun)
    Time Frame up to day 180

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    Measure Participants 31
    Count of Participants [Participants]
    22
    71%
    4. Secondary Outcome
    Title Number of Participants Who Experienced Reactivation
    Description To determine the frequency of disease reactivation prior to initiation of BMT preparative regimen (or day 180, if BMT preparative regimen not yet begun)
    Time Frame up to 180 days

    Outcome Measure Data

    Analysis Population Description
    all patients surviving to BMT or day 180 and achieving complete or partial response
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    Measure Participants 21
    Count of Participants [Participants]
    4
    12.9%
    5. Secondary Outcome
    Title Overall Survival to Day +100
    Description To determine overall survival to day +100 after BMT, for patients who have undergone BMT within 6 months of study entry
    Time Frame up to day 280

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    Measure Participants 11
    Count of Participants [Participants]
    9
    29%
    6. Secondary Outcome
    Title Disease Status at BMT
    Description To determine the rate of complete response at the time of BMT preparative regimen initiation
    Time Frame up to day 180

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    Measure Participants 11
    Count of Participants [Participants]
    8
    25.8%

    Adverse Events

    Time Frame Adverse event data were collected over the 8 weeks of the treatment period. All cause mortality was assessed up to day +100 after BMT, if participant proceeded to BMT by day 180. If participant did not proceed to BMT by day 180, all cause mortality was only assessed until day 180.
    Adverse Event Reporting Description
    Arm/Group Title Induction Therapy
    Arm/Group Description ATG, rabbit: intravenous, 5 mg/kg/dose, 5 consecutive days Dexamethasone: intravenous, 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days Etoposide: intravenous, 150 mg/m2 weekly, starting 7 days after first dose of Thymoglobulin Methotrexate and hydrocortisone: intrathecal to patients with central nervous system involvement, age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg, on day 7, 14, 21 and 42 ATG, rabbit: ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours). Etoposide: Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses. Methotrexate: Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients
    All Cause Mortality
    Induction Therapy
    Affected / at Risk (%) # Events
    Total 11/31 (35.5%)
    Serious Adverse Events
    Induction Therapy
    Affected / at Risk (%) # Events
    Total 22/31 (71%)
    Blood and lymphatic system disorders
    hospitalization 7/31 (22.6%) 8
    Eye disorders
    herpetic keratitis 1/31 (3.2%) 1
    Nervous system disorders
    status epilepticus 1/31 (3.2%) 1
    Renal and urinary disorders
    acute kidney injury 3/31 (9.7%) 3
    Respiratory, thoracic and mediastinal disorders
    respiratory failure 4/31 (12.9%) 4
    Vascular disorders
    multiple organ failure 4/31 (12.9%) 4
    hypotension 3/31 (9.7%) 3
    Other (Not Including Serious) Adverse Events
    Induction Therapy
    Affected / at Risk (%) # Events
    Total 31/31 (100%)
    Blood and lymphatic system disorders
    anemia 31/31 (100%) 31
    hemorrhage 5/31 (16.1%) 5
    thrombosis 2/31 (6.5%) 2
    Immune system disorders
    fever 30/31 (96.8%) 40
    Vascular disorders
    hypertension 3/31 (9.7%) 3

    Limitations/Caveats

    This is a single arm study.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Michael Jordan, MD
    Organization Cincinnati Children's Hospital Medical Center
    Phone 513-803-9063
    Email Michael.Jordan@cchmc.org
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01104025
    Other Study ID Numbers:
    • HIT-HLH
    First Posted:
    Apr 15, 2010
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2020