Clinical Trial: H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis

Brief Summary:

LCH III is an international, multicentric, prospective clinical study comprised of:

  • a randomized clinical trial for multisystem "RISK" patients and
  • a randomized clinical trial for multisystem "LOW RISK" patients and
  • a pilot study for patients with single system MFB and localized "SPECIAL SITES"

Detailed Summary:

Therapy for "LOW RISK" Patients:

The decision as to which research program you will be assigned will be made entirely by chance. The overall time of therapy will be 6 or 12 months as randomly assigned. The research program will be with the drugs Vinblastine and Prednisone.

Initial Therapy

  1. Prednisone given by mouth three times a day daily as a four-week course, then gradually decreased over 2 more weeks.
  2. Vinblastine will be given IV (into a vein) one day a week for 6 weeks.
  3. Patients who have no evidence of active disease at this time will proceed to continuation therapy.

Patients whose disease response is stable, mixed or worse will receive additional therapy with:

  1. Prednisone in 3 divided doses by mouth for 3 days every week, from week 7-12.

  2. Vinblastine IV one day a week for 6 more weeks.

    • If the disease is gone or better after this additional therapy continuation will begin.

Continuation Therapy

  1. Prednisone in 3 doses daily day 1-5 every 3 weeks until the end of month 6 or 12 from start of therapy, as randomized.
  2. Vinblastine IV day 1 every 3 weeks until the end of month 6 or 12 from start of therapy, as randomized.

Therapy for &qu
Sponsor: University of New Mexico

Current Primary Outcome: The proportion of non-responder in risk organs to the initial treatment [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 12 months ]
  • Proportion of responders (overall and in risk organs) [ Time Frame: at week 6 ]
  • Proportion of responders (overall and in risk organs) [ Time Frame: at week 12 ]
  • Reactivation free survival after response [ Time Frame: at week 12 ]
  • Time to NAD [ Time Frame: at weeks 6, 12, 7, or 13-23 ]


Original Secondary Outcome:

  • Overall survival [ Time Frame: 12 months ]
  • Proportion of responders (overall and in risk organs) [ Time Frame: at week 6 ]
  • Proportion of responders (overall and in risk organs) [ Time Frame: at week 12 ]
  • Reactivation free survival after response [ Time Frame: at week 12 ]
  • Time to NAD


Information By: University of New Mexico

Dates:
Date Received: June 14, 2007
Date Started: February 2004
Date Completion:
Last Updated: May 10, 2016
Last Verified: May 2016