Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061945
Status:
COMPLETED
Last Update Posted:
2022-05-03
First Post:
2003-06-05
Brief Title:
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Dose Escalation Study of Subcutaneous Campath-1H NSC 715969 IND 10864 During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia ALL
Status:
COMPLETED
Status Verified Date:
2022-04
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 III trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia Monoclonal antibodies such as alemtuzumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the feasibility and toxicity profiles of escalating doses of Campath-1H alemtuzumab given subcutaneously during post-remission intensification treatment of adults with acute lymphoblastic leukemia ALL
II To determine the disease-free survival DFS and overall survival OS when Campath-1H is used during post-remission intensification treatment of adults with ALL
III To determine whether antibody treatment with Campath-1H can further reduce minimal residual disease states in adult ALL
IV To obtain preliminary descriptive data on serum levels of Campath-1H during course IV module D using limited pharmacokinetic sampling during the phase I and II components of the study
V To obtain feasibility data on the addition of imatinib to Cancer and Leukemia Group B CALGB induction and postremission combination chemotherapy for patients with Philadelphia chromosome positive Ph ALL
OUTLINE This is a dose-escalation study of alemtuzumab
COURSE 1 module A Patients receive allopurinol orally PO 4 times daily QID on days 1-14 cyclophosphamide intravenously IV over 15-30 minutes on day 1 daunorubicin hydrochloride IV on days 1-3 vincristine sulfate IV on days 1 8 15 and 22 dexamethasone PO twice daily BID on days 1-7 and 15-21 asparaginase subcutaneously SC on days 5 8 11 15 18 and 22 and filgrastim SC on days 4-11 Patients who are Ph also receive imatinib mesylate PO on days 15-28
Note Patients who are 60 years old do not receive cyclophosphamide
COURSE 2 module B Patients receive methotrexate intrathecally IT on day 1 cytarabine IV over 3 hours on days 1-3 dexamethasone as eye drops QID on days 1-4 trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-29 and cyclophosphamide asparaginase and filgrastim as in course 1 Patients who are Ph also receive imatinib mesylate PO on days 1-28
COURSE 3 module C Patients receive vincristine sulfate IV on days 1 15 and 29 methotrexate IV over 3 hours and IT on days 1 15 and 19 methotrexate PO every 6 hours on days 1-2 15-16 and 29-30 mercaptopurine PO on days 1-35 leucovorin calcium IV on days 2 16 and 30 leucovorin calcium PO every 6 hours on days 3-4 and trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-43 Patients who are Ph also receive imatinib mesylate PO on days 1-42
COURSE 4 module D Patients receive alemtuzumab SC 3 times weekly for 4 weeks and begin acyclovir PO QID for 6 months continuing through course 8
Phase I Cohort 1 10 mg
Phase I Cohort 2 20 mg
Phase I Cohort 3Phase II MTD 30 mg
COURSE 5 module A Patients repeat course 1 minus allopurinol
COURSE 6 module B Patients repeat course 2
COURSE 7 module C Patients repeat course 3
COURSE 8 Patients receive mercaptopurine PO vincristine sulfate IV on day 1 dexamethasone PO on days 1-5 methotrexate PO on days 1 8 15 and 22 and trimethoprim-sulfamethoxazole PO BID 3 days weekly Patients who are Ph also receive imatinib mesylate PO on days 1-28 Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 10 years
I To determine the feasibility and toxicity profiles of escalating doses of Campath-1H alemtuzumab given subcutaneously during post-remission intensification treatment of adults with acute lymphoblastic leukemia ALL
II To determine the disease-free survival DFS and overall survival OS when Campath-1H is used during post-remission intensification treatment of adults with ALL
III To determine whether antibody treatment with Campath-1H can further reduce minimal residual disease states in adult ALL
IV To obtain preliminary descriptive data on serum levels of Campath-1H during course IV module D using limited pharmacokinetic sampling during the phase I and II components of the study
V To obtain feasibility data on the addition of imatinib to Cancer and Leukemia Group B CALGB induction and postremission combination chemotherapy for patients with Philadelphia chromosome positive Ph ALL
OUTLINE This is a dose-escalation study of alemtuzumab
COURSE 1 module A Patients receive allopurinol orally PO 4 times daily QID on days 1-14 cyclophosphamide intravenously IV over 15-30 minutes on day 1 daunorubicin hydrochloride IV on days 1-3 vincristine sulfate IV on days 1 8 15 and 22 dexamethasone PO twice daily BID on days 1-7 and 15-21 asparaginase subcutaneously SC on days 5 8 11 15 18 and 22 and filgrastim SC on days 4-11 Patients who are Ph also receive imatinib mesylate PO on days 15-28
Note Patients who are 60 years old do not receive cyclophosphamide
COURSE 2 module B Patients receive methotrexate intrathecally IT on day 1 cytarabine IV over 3 hours on days 1-3 dexamethasone as eye drops QID on days 1-4 trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-29 and cyclophosphamide asparaginase and filgrastim as in course 1 Patients who are Ph also receive imatinib mesylate PO on days 1-28
COURSE 3 module C Patients receive vincristine sulfate IV on days 1 15 and 29 methotrexate IV over 3 hours and IT on days 1 15 and 19 methotrexate PO every 6 hours on days 1-2 15-16 and 29-30 mercaptopurine PO on days 1-35 leucovorin calcium IV on days 2 16 and 30 leucovorin calcium PO every 6 hours on days 3-4 and trimethoprim-sulfamethoxazole PO BID 3 times weekly on days 1-43 Patients who are Ph also receive imatinib mesylate PO on days 1-42
COURSE 4 module D Patients receive alemtuzumab SC 3 times weekly for 4 weeks and begin acyclovir PO QID for 6 months continuing through course 8
Phase I Cohort 1 10 mg
Phase I Cohort 2 20 mg
Phase I Cohort 3Phase II MTD 30 mg
COURSE 5 module A Patients repeat course 1 minus allopurinol
COURSE 6 module B Patients repeat course 2
COURSE 7 module C Patients repeat course 3
COURSE 8 Patients receive mercaptopurine PO vincristine sulfate IV on day 1 dexamethasone PO on days 1-5 methotrexate PO on days 1 8 15 and 22 and trimethoprim-sulfamethoxazole PO BID 3 days weekly Patients who are Ph also receive imatinib mesylate PO on days 1-28 Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 10 years
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 |
|---|---|---|---|
| CDR302482 | None | None | None |
| NCI-2012-02807 | REGISTRY | None | None |
| CALGB-10102 | OTHER | None | None |
| CALGB 10102 | OTHER | None | None |
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |