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Compares treatment options for Langerhans Cell Histiocytosis
Official title Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
ClinicalTrials.gov ID: NCT02670707
What this study is testing
What is Cytarabine?
Cytarabine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for langerhans cell histiocytosis.
Also referred to as cytosine arabinoside (ara-C).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a cancer that begins in LCH cells (a type of dendritic cell which fights infection).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.
- Patient must be between 0-21 years of age.
- Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.
You likely can't join if
- Patient may not have received any prior systemic cytotoxic or other chemotherapies for LCH or any other malignant disorder prior to the initiation of...
- Patient may not have disease limited to a single skin or bone site, with the following exceptions:
- Central Nervous System (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital...
- Functionally critical lesions: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at...
- Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously...
- Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance \< 50 ml/m2/1.73m\^2).
See the full eligibility criteria
- Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.
- Patient must be between 0-21 years of age.
- Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥ 50%.
- Patient may not have received any prior systemic cytotoxic or other chemotherapies for LCH or any other malignant disorder prior to the initiation of protocol therapy on TXCH LCH0115 with the exception of: Steroid...
- Patient may not have disease limited to a single skin or bone site, with the following exceptions:
- Central Nervous System (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa...
- Functionally critical lesions: A single lesion not described above which may cause "functionally critical anatomic abnormality" wherein attempts at local therapy (such as surgical curettage or radiation) would cause...
- Asynchronous multisite LCH presentation: A patient may also have any single site of disease involvement at the time of enrollment if they previously had at least one other site of LCH disease in the past (which may have...
- Patient may not have severe renal disease (creatinine greater than 3 times normal for age OR creatinine clearance \< 50 ml/m2/1.73m\^2).
- Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR aspartate aminotransferase (AST) greater than 500 IU/L), unless hepatic injury is due to LCH.
- Female patients may not be pregnant or breastfeeding.
- Patients of reproductive potential not willing to use an adequate method of birth control for the duration of the study.
- Patients who are HIV positive may not be enrolled. NOTE: Patients excluded for laboratory abnormalities or performance score only may be enrolled on the study with written approval from the Coordinating Center PI or...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- San Diego, California, United States
- Minneapolis, Minnesota, United States
- Columbus, Ohio, United States
- Allentown, Pennsylvania, United States
- Austin, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- McAllen, Texas, United States
- San Antonio, Texas, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; San Diego, California, United States; Minneapolis, Minnesota, United States; Columbus, Ohio, United States; Allentown, Pennsylvania, United States; Austin, Texas, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.