RECRUITING

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age \< 18 years).

Official Title

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Quick Facts

Study Start:2016-11-02

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02205762

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Stratum I * Patients must be less than 18 years of age at the time of diagnosis. * Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis according to the criteria described in Section 6.1 * Signed informed consent form * Stratum II * Patients of Stratum I who have: * Progressive disease (AD worse) in non-risk organs after 6 weeks (Initial Course * AD intermediate or worse in non-risk organs or AD better in risk organs after 12 weeks (Initial Course 2) * Disease progression (AD worse) in non-risk organs at any time during continuation treatment * Active disease at the end of Stratum I treatment * Disease reactivation in non-risk organs at any time after completion of Stratum I treatment * Stratum III * Patients from Stratum I who fulfill the following criteria: * AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2). * Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as * Hb \<70 g/L (\<7.0 g/dl) and/or transfusion dependency * PLT \<20 x109/L (20,000/μL) and/or transfusion dependency (both criteria have to be fulfilled) AND/OR * Liver dysfunction (or digestive involvement with protein loss) * Total protein \<55 g/L or substitution dependency * Albumin \<25 g/L or substitution dependency (at least one of the two criteria to be fulfilled) * Stratum IV * Patients from Stratum I or Stratum III who fulfill the following criteria: * AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2) of Stratum I OR * AD worse after the 2nd and 3rd 2-CdA/Ara-C course, and those AD worse or AD intermediate after the 4th 2-CdA/Ara-C course of Stratum III AND * Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as defined in Table XI (see Section 10.3.1). * Informed consent: All patients or their legal guardians (if the patient is \<18 years of age) must sign an Ethics or institutional Review Board approved consent form indicating their awareness of the investigational nature and the risks of this study. When appropriate, younger patients will be included in all discussions in order to obtain assent. * Adequate organ function: Patients should have adequate hepatic, renal, cardiac and pulmonary function to undergo reduced intensity HCT based upon local institutional guidelines, or at a minimum meet requirements noted in eligibility checklist Appendix A-VIII_1. However, significant hepatic and pulmonary dysfunction, if secondary to underlying LCH disease activity, will not exclude patients from protocol enrollment and should be discussed with the National PI Coordinator and the Coordinating Principal Investigator. * Stratum V * All patients with verified diagnosis of LCH and MRI findings consistent with ND-CNSLCH irrespective of previous treatments (also those not registered to other Strata ofLCH-IV). * Patients with isolated tumorous CNS-LCH (including isolated DI with mass lesion in the hypothalamus-pituitary axis). In patients with already established diagnosis of LCH and radiologic finding of CNS lesions compatible with LCH, a biopsy of the lesion is not obligatory. In all other cases a biopsy of the lesion is needed for inclusion into the study * Stratum VI * Stratum VII -- All patients registered in LCH IV (regardless of treatment) as long as consent for longterm follow-up has not been withheld.	* Stratum I * Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy) * LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease * Prior systemic therapy * Stratum II * Patients with progressive disease in risk organs * Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations * No written consent of the patient or his/her parents or legal guardian * Stratum III * The presence of any of the following criteria will exclude the patient from the study: * Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of risk organ involvement. * Inadequate renal function as defined by serum creatinine \> 3x normal for age * Stratum IV * Pulmonary failure (requiring mechanical ventilation) not due to active LCH. * Isolated liver sclerosis or pulmonary fibrosis, without active LCH. * Uncontrolled active life-threatening infection. * Decreased renal function with a GFR of less than 50ml/1.73m2/min. * Pregnancy or active breast feeding * Failure to provide signed informed consent * Stratum VI * Patients with SS-LCH who have an isolated tumorous CNS lesion (they are eligible for Stratum V), * Patients with isolated "CNS-risk" or multifocal bone lesions (they are eligible for Stratum I, Group 2)

Inclusion Criteria

Exclusion Criteria

* Stratum I
* Patients must be less than 18 years of age at the time of diagnosis.
* Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis according to the criteria described in Section 6.1
* Signed informed consent form
* Stratum II
* Patients of Stratum I who have:
* Progressive disease (AD worse) in non-risk organs after 6 weeks (Initial Course
* AD intermediate or worse in non-risk organs or AD better in risk organs after 12 weeks (Initial Course 2)
* Disease progression (AD worse) in non-risk organs at any time during continuation treatment
* Active disease at the end of Stratum I treatment
* Disease reactivation in non-risk organs at any time after completion of Stratum I treatment
* Stratum III
* Patients from Stratum I who fulfill the following criteria:
* AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2).
* Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as
* Hb \<70 g/L (\<7.0 g/dl) and/or transfusion dependency
* PLT \<20 x109/L (20,000/μL) and/or transfusion dependency (both criteria have to be fulfilled) AND/OR
* Liver dysfunction (or digestive involvement with protein loss)
* Total protein \<55 g/L or substitution dependency
* Albumin \<25 g/L or substitution dependency (at least one of the two criteria to be fulfilled)
* Stratum IV
* Patients from Stratum I or Stratum III who fulfill the following criteria:
* AD worse in risk organs after week 6 (after Initial Course 1), or AD worse or AD intermediate in risk organs after week 12 (after Initial Course 2) of Stratum I OR
* AD worse after the 2nd and 3rd 2-CdA/Ara-C course, and those AD worse or AD intermediate after the 4th 2-CdA/Ara-C course of Stratum III AND
* Presence of unequivocally severe organ dysfunction at the above mentioned evaluation points (hematological dysfunction, liver dysfunction, or both of them) as defined in Table XI (see Section 10.3.1).
* Informed consent: All patients or their legal guardians (if the patient is \<18 years of age) must sign an Ethics or institutional Review Board approved consent form indicating their awareness of the investigational nature and the risks of this study. When appropriate, younger patients will be included in all discussions in order to obtain assent.
* Adequate organ function: Patients should have adequate hepatic, renal, cardiac and pulmonary function to undergo reduced intensity HCT based upon local institutional guidelines, or at a minimum meet requirements noted in eligibility checklist Appendix A-VIII_1. However, significant hepatic and pulmonary dysfunction, if secondary to underlying LCH disease activity, will not exclude patients from protocol enrollment and should be discussed with the National PI Coordinator and the Coordinating Principal Investigator.
* Stratum V
* All patients with verified diagnosis of LCH and MRI findings consistent with ND-CNSLCH irrespective of previous treatments (also those not registered to other Strata ofLCH-IV).
* Patients with isolated tumorous CNS-LCH (including isolated DI with mass lesion in the hypothalamus-pituitary axis). In patients with already established diagnosis of LCH and radiologic finding of CNS lesions compatible with LCH, a biopsy of the lesion is not obligatory. In all other cases a biopsy of the lesion is needed for inclusion into the study
* Stratum VI
* Stratum VII -- All patients registered in LCH IV (regardless of treatment) as long as consent for longterm follow-up has not been withheld.

* Stratum I
* Pregnancy (patients of child-bearing age must be appropriately tested before chemotherapy)
* LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease
* Prior systemic therapy
* Stratum II
* Patients with progressive disease in risk organs
* Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations
* No written consent of the patient or his/her parents or legal guardian
* Stratum III
* The presence of any of the following criteria will exclude the patient from the study:
* Isolated sclerosing cholangitis without evidence of active hepatic LCH as the only evidence of risk organ involvement.
* Inadequate renal function as defined by serum creatinine \> 3x normal for age
* Stratum IV
* Pulmonary failure (requiring mechanical ventilation) not due to active LCH.
* Isolated liver sclerosis or pulmonary fibrosis, without active LCH.
* Uncontrolled active life-threatening infection.
* Decreased renal function with a GFR of less than 50ml/1.73m2/min.
* Pregnancy or active breast feeding
* Failure to provide signed informed consent
* Stratum VI
* Patients with SS-LCH who have an isolated tumorous CNS lesion (they are eligible for Stratum V),
* Patients with isolated "CNS-risk" or multifocal bone lesions (they are eligible for Stratum I, Group 2)

Contacts and Locations

Study Contact

Heidi M Clough, BSN, RN

CONTACT

901-595-0362

Heidi.clough@stjude.org

Sara G Hastings, MBA

CONTACT

Sara.Hastings@stjude.org

Principal Investigator

Milen Minkov, MD, Ph.D

STUDY_CHAIR

Children's Cancer Research Institute / St. Anna Children's Hospital

Carlos Rodriguez-Galindo, MD

STUDY_CHAIR

North American Consortium for Histiocytosis

Study Locations (Sites)

Children's of Alabama

Birmingham, Alabama, 35233

United States

Phoenix Children's Hospital

Phoenix, Arizona, 85006

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

United States

Children's Hospital of Los Angeles

Los Angeles, California, 90027

United States

Valley Children's Healthcare

Madera, California, 93636

United States

UCSF Benioff Children's Hospital of Oakland

Oakland, California, 94609

United States

Children's Hospital of Orange County

Orange, California, 92868

United States

UCSF Helen Diller Family Cancer Center

San Francisco, California, 94158-0106

United States

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

Children's National Medical Center

Washington, District of Columbia, 20010

United States

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Children's Healthcare of Atlanta, Emory

Atlanta, Georgia, 30342

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991

United States

Children's Mercy Hospitals

Kansas City, Kansas, 64108

United States

University of Kentucky A.B.Chandler Medical Center

Lexington, Kentucky, 40536

United States

University of Louisville, Norton Children's Hospital

Louisville, Kentucky, 40202

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Children's Minnesota

Minneapolis, Minnesota, 55404

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Cohen Children's Medical Center

New Hyde Park, New York, 11040

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Columbia University / Herbert Irving Cancer Center

New York, New York, 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York

United States

SUNY Upstate Medical University

Syracuse, New York, 13210

United States

Carolinas Medical Center, Levine Children's Hospital

Charlotte, North Carolina, 28203

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Rainbow Babies & Children's Hospital, University Hospitals

Cleveland, Ohio, 44106

United States

The Toledo Hospital, Toledo Children's Hospital

Toledo, Ohio, 43606

United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425

United States

Greenville Health System BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

United States

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Children's Medical Center Dallas, UT Southwestern

Dallas, Texas

United States

Providence Sacred Heart Children's Hospital

Spokane, Washington, 99204

United States

Madigan Army Medical Center

Tacoma, Washington, 98431

United States

American Family Children's Hospital University of Wisconsin

Madison, Wisconsin, 53792

United States

Collaborators and Investigators

Sponsor: North American Consortium for Histiocytosis

Milen Minkov, MD, Ph.D, STUDY_CHAIR, Children's Cancer Research Institute / St. Anna Children's Hospital
Carlos Rodriguez-Galindo, MD, STUDY_CHAIR, North American Consortium for Histiocytosis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-11-02

Study Completion Date2025-07

Study Record Updates

Study Start Date2016-11-02

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Langerhans cell histiocytosis

Additional Relevant MeSH Terms

Langerhans Cell Histiocytosis