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Chemotherapy
Combination Therapy for Langerhans Cell Histiocytosis
Phase 2 & 3
Recruiting
Research Sponsored by North American Consortium for Histiocytosis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis according to the criteria described in Section 6.1
Stratum I: Patients must have histological verification of the diagnosis of Langerhans cell histiocytosis according to the specified criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is for kids with a rare cancer called Langerhans Cell Histiocytosis.
Who is the study for?
This trial is for children and adolescents under 18 with Langerhans Cell Histiocytosis (LCH). They must have a confirmed diagnosis, not be pregnant or breastfeeding, and have no prior systemic therapy. Participants need consent from parents/guardians if underage. Certain severe organ dysfunctions or infections may disqualify them.Check my eligibility
What is being tested?
The study tests various treatments including Prednisone, stem cell transplantation, immunoglobulin, INDOMETHACIN, mercaptopurine, Cytosine Arabinoside, Vinblastine, Methotrexate and 2-chlorodeoxyadenosine in young patients with LCH to find the most effective approach.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk; liver toxicity; bone marrow suppression causing anemia or bleeding issues; nausea; hair loss due to chemotherapy drugs like Methotrexate and Vinblastine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My diagnosis of Langerhans cell histiocytosis is confirmed by tissue examination.
Select...
My diagnosis of Langerhans cell histiocytosis is confirmed by tissue analysis.
Select...
My non-risk organs are at least intermediate AD or my risk organs are better AD after 12 weeks.
Select...
I have newly diagnosed single-system Langerhans Cell Histiocytosis not in my bones, brain, or 'CNS-risk' areas.
Select...
I was under 18 when I was diagnosed.
Select...
I was diagnosed before turning 18.
Select...
My condition has worsened in areas of my body not considered at high risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative incidence of specific Permanent Consequences e.g. diabetes insipidus (DI), growth hormone deficiency (GHD), neuropsychological impairment, etc.
Overall and disease free survival at 1 and 3 years after reduced intensity conditioning hematopoietic stem cell transplantation (RIC-HSCT)
Percentage of Patients with Reactivation Free Survival
+3 moreSecondary outcome measures
Cumulative incidence of reactivations in risk organs
Early and late mortality
Early and late toxicity
+19 moreSide effects data
From 2016 Phase 3 trial • 854 Patients • NCT0000338998%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)
Trial Design
6Treatment groups
Experimental Treatment
Group I: Stratum VIExperimental Treatment6 Interventions
Natural history and management of "other" SS-LCH not eligible for stratum I group 2.
Treatment Options- Management (mostly "wait & see" and topical treatment) is left to the discretion of the treating physician. All treatments and disease responses must be reported in the database. In the case of uncertainties please contact your National Coordinator.
Patients being followed on Stratum VI who have progression of disease to MSLCH, multifocal bone disease or CNS-risk bone lesions should be enrolled on Stratum I therapy.
Patients being followed on Stratum VI who develop isolated tumorous or neurodegenerative CNS-LCH should be enrolled on Stratum V.
Group II: Stratum VExperimental Treatment3 Interventions
Stratum V Monitoring and Treatment of isolated tumorous and neurodegenerative CNS-LCH
- Special regimens will be offered to patients with isolated tumorous CNS-LCH (repeated 2-CdA courses) and to patients with clinically manifested ND-CNS-LCH (+/- extracranial LCH manifestations). For the last group monotherapy with Ara-C courses or (Intravenous immunoglobulin)IVIG will be offered depending on physician's choice.
Group III: Stratum IVExperimental Treatment1 Intervention
To determine the overall and disease free survival at 1 and 3 years after reduced intensity conditioning hematopoietic stem cell transplantation (RIC-HSCT). Salvage treatment option for MS-LCH patients with risk organ involvement, who fail to respond to front-line therapy (Stratum I) OR to the salvage 2- CdA/Ara-C regimen (Stratum III).
Group IV: Stratum IIIExperimental Treatment1 Intervention
Salvage treatment for risk LCH To assess the efficacy of the combination 2-CdA/Ara-C (Cytosine Arabinoside and 2-chlorodeoxyadenosine) in MS-LCH (patients with risk organ involvement, who fail to respond to front-line (Stratum I) therapy.
The initial therapy consists of 2 courses of 2-CdA/Ara-C. Continuation of outlined treatment to be assessed at assigned intervals in each stratum.
Group V: Stratum IIExperimental Treatment6 Interventions
A uniform "intensive" 24-week course consisting of prednisolone, vincristine and cytosine-arabinoside will be introduced in Stratum II for eligible patients. It will be followed by a continuation therapy to total treatment duration of 24 months. Participants who after SL-IT (week 24) have a response (NAD or AD better) are eligible for randomization between the continuation arms "INDOMETHACIN" and "6-MP/MTX" (mercaptopurine and Methotrexate).
Group VI: Stratum IExperimental Treatment3 Interventions
Stratum I The combination of Prednisone and vinblastine is the standard first-line combination for patients needing systemic therapy (Stratum I). Patients with MS-LCH and involvement of risk organs, who do not respond to 6-12 weeks of standard therapy, will be immediately switched to alternative treatment approaches (Stratum III or Stratum IV).
Further therapy prolongation (12 vs. 24 months) and intensification (± mercaptopurine) will further reduce the reactivation rate and the permanent consequences.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Intravenous immunoglobulin
2017
Completed Phase 3
~330
mercaptopurine
1999
Completed Phase 3
~13700
Cytosine Arabinoside
2003
Completed Phase 3
~500
Vinblastine
1998
Completed Phase 3
~5260
Methotrexate
2013
Completed Phase 4
~3800
Find a Location
Who is running the clinical trial?
Histiocyte SocietyOTHER
1 Previous Clinical Trials
376 Total Patients Enrolled
North American Consortium for HistiocytosisLead Sponsor
4 Previous Clinical Trials
377 Total Patients Enrolled
Milen Minkov, MD, Ph.DStudy ChairChildren's Cancer Research Institute / St. Anna Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have lung failure, liver issues, or lung fibrosis due to LCH. I am not pregnant, breastfeeding, and I can sign consent.My diagnosis of Langerhans cell histiocytosis is confirmed by tissue examination.I have Langerhans Cell Histiocytosis with specific brain or bone involvement.My diagnosis of Langerhans cell histiocytosis is confirmed by tissue analysis.My non-risk organs are at least intermediate AD or my risk organs are better AD after 12 weeks.I have newly diagnosed single-system Langerhans Cell Histiocytosis not in my bones, brain, or 'CNS-risk' areas.My disease worsened after specific treatments and I have severe organ issues.I have LCH with specific brain MRI findings, regardless of my past treatments.I was under 18 when I was diagnosed.All patients from a specific program (LCH IV) who have not refused to be followed up for a long time.My LCH is worsening in critical organs but shows no active signs, and I or my guardian haven't consented in writing.My condition worsened in certain organs after treatment, and I now have severe organ dysfunction.I was diagnosed before turning 18.My cancer has worsened in certain areas after initial treatment.I have a specific liver condition without liver disease and poor kidney function.This is a specific group of people being targeted for the study.I am pregnant or have long-term effects from LCH without active disease, and have had prior systemic therapy.My condition has worsened in areas of my body not considered at high risk.This is a specific group within the study.
Research Study Groups:
This trial has the following groups:- Group 1: Stratum II
- Group 2: Stratum III
- Group 3: Stratum V
- Group 4: Stratum VI
- Group 5: Stratum IV
- Group 6: Stratum I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Langerhans Cell Histiocytosis Patient Testimony for trial: Trial Name: NCT02205762 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what medical purposes is Vinblastine commonly prescribed?
"While most often given to small cell lung cancer patients, vinblastine has also been shown to ameliorate symptoms in those suffering from advanced testicular cancer, thyroiditis, and ulcerative colitis."
Answered by AI
What is the sample size for this experiment?
"In order for this research to be conducted, 1400 individuals that fit the pre-determined criteria must agree to participate. Some of the locations where interested parties can sign up include Providence Sacred Heart Children's Hospital in Spokane, Washington and University of Kentucky A.B.Chandler Medical Center in Lexington, Kentucky."
Answered by AI
Is this trial widespread throughout North America?
"Currently, this clinical trial is enrolling patients at 37 locations. While some of these sites are in Spokane, Lexington and New york, the other 34 sites are located elsewhere. By selecting the location closest to you, potential participants can minimize travel requirements."
Answered by AI
Are researchers still enrolling people in this trial?
"Yes, this is an ongoing study that was initially posted on July 1st, 2014. The most recent update to the listing was on February 17th, 2022. Currently, 37 different medical facilities are recruiting 1400 patients in total."
Answered by AI
Is Vinblastine a common medication in clinical trials?
"There are currently 780 active studies and 210 phase 3 clinical trials underway for the use of Vinblastine. Many of these research initiatives are based in Sacramento, California; however, there are 26774 locations worldwide where similar trials are being conducted."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
What site did they apply to?
Children's Mercy Hospitals
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
NOOO ONE AROUND HERE SEEMS NOT TO KNOW HOW TO TREAT ADULT LANGERHANS CELL HISTOCYTOSIS!!PLEASE I NEED HELP FAST!! I ALSO HAVE POSITIVE BRAF. NO ONE CARES!!PLEADE HELP.
PatientReceived 2+ prior treatments
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