Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00276757 |
Recruitment Status :
Completed
First Posted : January 13, 2006
Last Update Posted : January 10, 2014
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | January 12, 2006 | |||
First Posted Date ICMJE | January 13, 2006 | |||
Last Update Posted Date | January 10, 2014 | |||
Study Start Date ICMJE | April 2001 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis | |||
Official Title ICMJE | Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may be an effective treatment for Langerhans cell histiocytosis. PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well it works in treating young patients with Langerhans cell histiocytosis. |
|||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, multicenter study with one pilot nonrandomized stratum. Patients are stratified according to number of systems involved (multiple vs single) and organs involved (at risk vs low risk).
NOTE: *Patients receive oral prednisolone 3 times daily on days 43-45, 50-52, 57-59, 64-66, 71-73, and 78-80 only during the second course of initial therapy. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 376 patients will be accrued for this study. |
|||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment |
|||
Condition ICMJE | Childhood Langerhans Cell Histiocytosis | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE | Not Provided | |||
Publications * | Gadner H, Minkov M, Grois N, Potschger U, Thiem E, Arico M, Astigarraga I, Braier J, Donadieu J, Henter JI, Janka-Schaub G, McClain KL, Weitzman S, Windebank K, Ladisch S; Histiocyte Society. Therapy prolongation improves outcome in multisystem Langerhans cell histiocytosis. Blood. 2013 Jun 20;121(25):5006-14. doi: 10.1182/blood-2012-09-455774. Epub 2013 Apr 15. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
376 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | June 2013 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | up to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Austria, Canada, France, Germany, Ireland, Italy, Sweden, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00276757 | |||
Other Study ID Numbers ICMJE | CDR0000454768 HISTSOC-LCH-III CCLG-LCH-III EU-20587 CCLG-LCH-2002-07 UMN-2006NT004 |
|||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Not Provided | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Histiocyte Society | |||
Original Study Sponsor ICMJE | United Kingdom Children's Cancer Study Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | National Cancer Institute (NCI) | |||
Verification Date | May 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |