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

NCT00488605 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: H-9926-LCH III
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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"

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• The proportion of non-responder in risk organs to the initial treatment

  12 months

Secondary Outcomes (5)

• Overall survival

  12 months

• Proportion of responders (overall and in risk organs)

  at week 6

• Proportion of responders (overall and in risk organs)

  at week 12

• Reactivation free survival after response

  at week 12

• Time to NAD

  at weeks 6, 12, 7, or 13-23

Study Arms (2)

Treatment Arm A

ACTIVE COMPARATOR

Drug: Prednisone, Vinblastin, 6-mercaptopuroine

Treatment Arm B

EXPERIMENTAL

Drug: Leucovorin, Methotrexate, Vinblastine, Prednisone

Interventions

Prednisone, Vinblastin, 6-mercaptopuroine DRUG

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.

Treatment Arm A

Leucovorin, Methotrexate, Vinblastine, Prednisone DRUG

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.

Also known as: leukovorin rescue

Treatment Arm B

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not specified

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

Prednisone; Vinblastine; Leucovorin; Methotrexate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Aminopterin

Study Officials

• Jami Frost, M.D.

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2007
• First Posted: June 20, 2007
• Study Start: August 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

US (1)