Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488605
Status:
WITHDRAWN
Last Update Posted:
2023-08-03
First Post:
2007-06-14
Brief Title:
H-9926-LCH III Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
H-9926-LCH III Treatment Protocol of the Third International Study for Langerhans Cell Histiocytosis
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This is a duplicate record and the sponsor has registered the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
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 SPECIAL SITE Multi-focal Bone Involvement Patients
Treatment consists of an initial treatment of 6 weeks and a continuation treatment A second course is given only to patients with progressive disease The overall therapy time period is 6 months
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 PDNVBL with the experimental arm B PDNVBLMTX The primary endpoint is the proportion of non-responder in risk organs to the initial treatment
Non-response to initial therapy is defined as
death within 12 weeks of initial treatment or
progression worse in risk organs at week 6
lack of response intermediate response or progression in risk organs at week 12 as compared to the status of disease at week 6
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
Group 2 LOW RISK patients
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
Therapy for RISK Patients
Treatment A will consist of
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
6 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
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 didnt respond to the initial therapy by the 12th week will come off this study and proceed to other research programs
Treatment B will consist of
1 Initial Therapy
2 Prednisone given by mouth three times a day daily as a four-week course then gradually decreased over 2 more weeks
3 Vinblastine will be given IV one day a week for 6 weeks
4 Methotrexate given as a 24 hour IV infusion day 1 of weeks 1 3 and 5 followed by leucovorin
5 Leucovorin is a drug that will be given to help the body remove the methotrexate and decrease the possible side effects This is sometimes called a leukovorin rescue The drug will be given by mouth
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
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
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 didnt respond to the initial research program by the 12th week will come off this research study and proceed to another research program
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 SPECIAL SITE Multi-focal Bone Involvement Patients
Treatment consists of an initial treatment of 6 weeks and a continuation treatment A second course is given only to patients with progressive disease The overall therapy time period is 6 months
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 PDNVBL with the experimental arm B PDNVBLMTX The primary endpoint is the proportion of non-responder in risk organs to the initial treatment
Non-response to initial therapy is defined as
death within 12 weeks of initial treatment or
progression worse in risk organs at week 6
lack of response intermediate response or progression in risk organs at week 12 as compared to the status of disease at week 6
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
Group 2 LOW RISK patients
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
Therapy for RISK Patients
Treatment A will consist of
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
6 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
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 didnt respond to the initial therapy by the 12th week will come off this study and proceed to other research programs
Treatment B will consist of
1 Initial Therapy
2 Prednisone given by mouth three times a day daily as a four-week course then gradually decreased over 2 more weeks
3 Vinblastine will be given IV one day a week for 6 weeks
4 Methotrexate given as a 24 hour IV infusion day 1 of weeks 1 3 and 5 followed by leucovorin
5 Leucovorin is a drug that will be given to help the body remove the methotrexate and decrease the possible side effects This is sometimes called a leukovorin rescue The drug will be given by mouth
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
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
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 didnt respond to the initial research program by the 12th week will come off this research study and proceed to another research program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None