Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089349
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-08-04
Brief Title:
Alemtuzumab With or Without Methotrexate and Mercaptopurine in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Campath-1H in Children With Acute Lymphoblastic Leukemia in Second or Greater Relapse or Twice Induction Failure
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase II trial is studying how well giving alemtuzumab with or without methotrexate and mercaptopurine works in treating young patients with relapsed acute lymphoblastic leukemia Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Drugs used in chemotherapy such as methotrexate and mercaptopurine work in different ways to stop cancer cells from dividing so they stop growing or die Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate to alemtuzumab alone and in combination with methotrexate and mercaptopurine in children with acute lymphoblastic leukemia in second or greater relapse or twice induction failure
II Determine the toxicity of these regimens in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of alemtuzumab in these patients II Determine the immune response in patients treated with alemtuzumab III Determine changes in the number of CD52-positive cells in the blood and marrow of patients treated with alemtuzumab
IV Determine the rate and timing of clearance of peripheral circulating lymphoblasts in patients treated with these regimens
OUTLINE This is a multicenter study
Course 1 Patients receive alemtuzumab IV over 2 hours on days 1-5 8 10 12 15 17 19 22 24 and 26 in the absence of disease progression or unacceptable toxicity Patients achieving complete remission CR partial remission PR or cytolytic PR at day 29 or patients with CNS disease that achieve a CNS 1 or CNS 2 status proceed to course 2
Courses 2 and 3 Patients receive alemtuzumab IV over 2 hours on days 1 8 15 and 22 methotrexate IV continuously over 24 hours on day 1 and then orally once daily on days 8 15 and 22 and oral mercaptopurine once daily on days 1-28 Patients with a CR or PR at day 29 proceed to course 3 In course 3 patients receive alemtuzumab methotrexate and mercaptopurine as in course 2
CNS prophylaxis Patients receive methotrexate intrathecally on day 1 of courses 2 and 3 on day 1 of courses 2 and 3
NOTE CNS-negative patients receive methotrexate intrathecally on day 15 of course 1 and day 1 of courses 2 and 3
I Determine the response rate to alemtuzumab alone and in combination with methotrexate and mercaptopurine in children with acute lymphoblastic leukemia in second or greater relapse or twice induction failure
II Determine the toxicity of these regimens in these patients
SECONDARY OBJECTIVES
I Determine the pharmacokinetics of alemtuzumab in these patients II Determine the immune response in patients treated with alemtuzumab III Determine changes in the number of CD52-positive cells in the blood and marrow of patients treated with alemtuzumab
IV Determine the rate and timing of clearance of peripheral circulating lymphoblasts in patients treated with these regimens
OUTLINE This is a multicenter study
Course 1 Patients receive alemtuzumab IV over 2 hours on days 1-5 8 10 12 15 17 19 22 24 and 26 in the absence of disease progression or unacceptable toxicity Patients achieving complete remission CR partial remission PR or cytolytic PR at day 29 or patients with CNS disease that achieve a CNS 1 or CNS 2 status proceed to course 2
Courses 2 and 3 Patients receive alemtuzumab IV over 2 hours on days 1 8 15 and 22 methotrexate IV continuously over 24 hours on day 1 and then orally once daily on days 8 15 and 22 and oral mercaptopurine once daily on days 1-28 Patients with a CR or PR at day 29 proceed to course 3 In course 3 patients receive alemtuzumab methotrexate and mercaptopurine as in course 2
CNS prophylaxis Patients receive methotrexate intrathecally on day 1 of courses 2 and 3 on day 1 of courses 2 and 3
NOTE CNS-negative patients receive methotrexate intrathecally on day 15 of course 1 and day 1 of courses 2 and 3
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 |
|---|---|---|---|
| U01CA097452 | NIH | None | httpsreporternihgovquickSearchU01CA097452 |
| ADVL0222 | None | None | None |
| CDR0000378240 | None | None | None |
| NCI-05-C-0248 | None | None | None |
| COG-ADVL0222 | None | None | None |