Clinical Trial: Phase II Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis

Brief Summary: This research study is evaluating a drug called clofarabine as a possible treatment for Langerhans Cell Histiocytosis( LCH )

Detailed Summary:

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational intervention, to learn whether the drug works in treating a specific disease, in this case, clofarabine to treat LCH.

"Investigational" means that the intervention is still being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved clofarabine for your disease.

Clofarabine is a chemotherapy drug that has been used and is approved by the FDA for the treatment of leukemia in children and adults. Information from other research studies suggests that this drug may also be effective in participants with LCH.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Overall Response Rate [ Time Frame: Week 7 ]

Responses will be assessed using the standard criteria proposed by the Histiocyte Society


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival [ Time Frame: At three and five years ]
  • Overall Survival [ Time Frame: At three and five years ]
  • The proportion of patients who experience a toxicity-event requiring stopping clofarabine [ Time Frame: Baseline, Up to 24 weeks ]
  • Proportion of participants with grade 3-4 toxicity [ Time Frame: Baseline, Up to 24 Weeks ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: April 18, 2015
Date Started: May 2015
Date Completion: September 2022
Last Updated: April 25, 2017
Last Verified: April 2017