Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176462
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2005-09-12
Brief Title:
CINJALL Treatment for Children With Acute Lymphocytic Leukemia
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
CINJALL Treatment for Children With Acute Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia ALL At the same time doctors hope to define methods to identify those patients at higher risk for certain side effects as well as those who are at higher risk for relapse of their leukemia
Detailed Description:
Outline of Therapy
Combinations of chemotherapy drugs will be given orally intravenously and intrathecally directly into the cerebrospinal fluid by spinal tap over a period of roughly two and a half years
Therapy will be divided into five phases
Induction 4 weeks chemotherapy given to produce a clinical remission defined by normal blood counts with the absence of leukemia cells in the blood and fewer than 5 leukemia cells in the bone marrow
Consolidation 11 weeks chemotherapy given to consolidate the remission Delayed Intensification 7 weeks Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse
Intensive Continuation approximately 1 year Eight week cycles of chemotherapy given eight times
Continuation final year of therapy Eight week cycles of largely oral chemotherapy with one clinic visit for a lumbar puncture every eight weeks
Irradiation radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis
Follow-up After the conclusion of therapy there will be periodic office visits initially monthly then gradually spaced out to annual visits The purpose of these visits is to evaluate for late side-effects of therapy
Combinations of chemotherapy drugs will be given orally intravenously and intrathecally directly into the cerebrospinal fluid by spinal tap over a period of roughly two and a half years
Therapy will be divided into five phases
Induction 4 weeks chemotherapy given to produce a clinical remission defined by normal blood counts with the absence of leukemia cells in the blood and fewer than 5 leukemia cells in the bone marrow
Consolidation 11 weeks chemotherapy given to consolidate the remission Delayed Intensification 7 weeks Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse
Intensive Continuation approximately 1 year Eight week cycles of chemotherapy given eight times
Continuation final year of therapy Eight week cycles of largely oral chemotherapy with one clinic visit for a lumbar puncture every eight weeks
Irradiation radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis
Follow-up After the conclusion of therapy there will be periodic office visits initially monthly then gradually spaced out to annual visits The purpose of these visits is to evaluate for late side-effects of therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA072720 | NIH | IRB Number | httpsreporternihgovquickSearchP30CA072720 |
| 0220003389 | OTHER | None | None |