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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of New Mexico.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00488605
First received: June 14, 2007
Last updated: June 23, 2010
Last verified: May 2009
History of Changes
  Purpose

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"

Condition Intervention Phase
Leukemia
 Drug: Prednisone, Vinblastin, 6-mercaptopuroine
Drug: Leucovorin, Methotrexate, Vinblastine, Prednisone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: H-9926-LCH III: Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis

Resource links provided by NLM:

MedlinePlus related topics: Leukemia Steroids
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • The proportion of non-responder in risk organs to the initial treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 476
Study Start Date: February 2004
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Arm A Drug: Prednisone, Vinblastin, 6-mercaptopuroine
Initial Therapy:Prednisone- by mouth 3 times/day daily as a 4-week course, then gradually decreased over 2 more weeks. Vinblastine-IV (into a vein)1 day/week for 6 weeks. Patients w/o evidence of active disease at this time will proceed to continuation therapy. If disease is improved or unchanged, pts. will receive additional therapy with: Prednisone- 3 divided doses by mouth for 3 days every week, from week 7-12. Vinblastine- IV 1day/week for 6 more weeks. If the disease is gone or better after this additional therapy continuation will begin. Continuation Therapy: 6-MP:by mouth daily until the end of month 12. Prednisone in 3 doses daily day 1-5 every 3 weeks until the end of month 12. Vinblastine IV day 1 every 3 weeks until the end of month 12.
Experimental: Treatment Arm B Drug: Leucovorin, Methotrexate, Vinblastine, Prednisone
Initial Therapy:Prednisone-by mouth 3x/day daily as a 4-week course then gradually decreased over 2 more weeks. Vinblastine- IV 1 day/week for 6 weeks. Methotrexate-a 24 hour IV infusion day 1 of weeks 1, 3, and 5, followed by leucovorin.The drug will be given by mouth. Pts w/o evidence of active disease at this time will proceed to continuation therapy. Pts whose disease is improved or unchanged will receive additional therapy w/:Prednisone- 3 divided doses, days 1-3 weekly from week 7-12. Vinblastine IV 1day/week for 6 more weeks. Methotrexate-a 24 hour IV infusion day 1 of week 7, 9, and 11, followed by leucovorin. If the disease is gone or better after this additional therapy continuation will begin. Continuation Therapy: 6-MP by mouth daily until the end of month 12. Prednisone- 3 doses daily days 1-5 every 3 weeks until the end of month 12. Vinblastine IV day 1 every 3 weeks until the end of month 12. Methotrexate by mouth once weekly until the end of month 12.
Other Name: leukovorin rescue

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All newly diagnosed patients who meet the following criteria are eligible to be enrolled and followed in the study:

  • Definitive diagnosis of LCH
  • Age under 18 years
  • No prior treatment for LCH

Exclusion Criteria:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488605

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Jami Frost, M.D. University of New Mexico
  More Information

No publications provided

Responsible Party: Jami Frost, MD; Principal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00488605     History of Changes
Other Study ID Numbers: H-9926-LCH III
Study First Received: June 14, 2007
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Histiocytosis
Histiocytosis, Langerhans-Cell
Leukemia
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Neoplasms
Leucovorin
Levoleucovorin
Methotrexate
Prednisone
Vinblastine
Vitamin B Complex
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013