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Protocol Terapeutic LCH III
Protocol Terapeutic LCH III
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.
o 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.
Initial Therapy 4. Prednisone given by mouth three times a day daily as a four-week course,
then gradually decreased over 2 more weeks.
5. Vinblastine will be given IV (into a vein) one day a week for 6 weeks. 6. 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:
3. Prednisone in 3 divided doses days 1-3 weekly from week 7-12. 4. 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 3. Prednisone in 3 doses daily day 1-5 every 3 weeks until the end of
month 6. 4. Vinblastine IV day 1 every 3 weeks until the end of month 6.
Group 1 “RISK” patients:
The primary aim of the study is to compare the therapeutic efficacy of control arm A
(PDN+VBL) with the experimental arm B (PDN+VBL+MTX). The primary endpoint is the
proportion of non-responder in risk organs to the initial treatment.
If the null hypothesis is true, the two randomized treatment arms are equally effective in terms
of non-response. If the alternative hypotheses is true, there is a difference between the two
randomized arms in terms of efficacy.
The primary aim of the study is to compare the reactivation free survival rate in initial
responders at week 6 with continuation treatment for 6 months (Arm LR 6) versus 12 months
(Arm LR 12) in those patients without disease reactivation within the first 6 months.
If the null hypothesis is true, the reactivation rate of both randomized arms are equal. If the
alternative hypothesis is true, there is a difference between the two arms in terms of
reactivation frequency.
7. Initial Therapy 8. Prednisone given by mouth three times a day daily as a four-week course,
then gradually decreased over 2 more weeks.
9. Vinblastine will be given IV (into a vein) one day a week for 6 weeks. 10. Patients who
have no evidence of active disease at this time will proceed to continuation therapy.
Patients whose disease is improved or unchanged will receive additional therapy with:
5. Prednisone in 3 divided doses by mouth for 3 days every week, from week 7-12.
** If the disease is gone or better after this additional therapy continuation will begin.
Continuation Therapy:
5. 6-MP by mouth daily until the end of month 12. 6. Prednisone in 3 doses daily day 1-5
every 3 weeks until the end of month 12. 7. Vinblastine IV day 1 every 3 weeks until the end
of month 12.
** Those patients whose disease didn’t respond to the initial therapy by the 12th week will
come off this study and proceed to other research programs.
Patients whose disease is improved or unchanged will receive additional therapy with:
1. Prednisone in 3 divided doses, days 1-3 weekly from week 7-12.
2. Vinblastine IV one day a week for 6 more weeks.
3. Methotrexate given as a 24 hour IV infusion day 1 of week 7, 9, and 11, followed by
leucovorin.
o If the disease is gone or better after this additional therapy continuation will
begin.
Continuation Therapy:
1. 6-MP by mouth daily until the end of month 12.
2. Prednisone in 3 doses daily days 1-5 every 3 weeks until the end of month 12.
3. Vinblastine IV day 1 every 3 weeks until the end of month 12.
4. Methotrexate by mouth once weekly until the end of month 12.
Those patients whose disease didn’t respond to the initial research program by the 12th week
will come off this research study and proceed to another research program.
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
Locations
Investigators
Principal Investigator:
Jami Frost, M.D. University of New Mexico
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