Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262925
Status:
TERMINATED
Last Update Posted:
2015-05-05
First Post:
2005-12-06
Brief Title:
Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of MOAD Methotrexate Vincristine L-asparaginase and Dexamethasone With Subcutaneous Campath for Adults With Relapsed or Refractory Acute Leukemia ALL
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
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 combination chemotherapy together with alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic leukemia Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells 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 Giving combination chemotherapy together with alemtuzumab may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the complete response rate in patients with relapsed or refractory acute lymphoblastic leukemia treated with methotrexate vincristine asparaginase and dexamethasone MOAB in combination with alemtuzumab
II Determine disease-free andor overall survival of patients treated with this regimen
III Determine the toxic effects of this regimen in these patients
IV Correlate the density of cluster of differentiation 52 CD52 molecules on the surface of leukemic lymphoblasts with response in patients treated with this regimen
V Correlate the presence of minimal residual disease at the time of maximal response to this regimen with overall outcome in these patients
OUTLINE This is a multicenter study The study had two steps Step 1 5 mg dose of Campath alemtuzumab Step 2 10 mg dose of Campath
INDUCTION THERAPY Patients receive methotrexate intravenously IV on day 1 vincristine IV and asparaginase intramuscularly IM on day 2 oral dexamethasone on days 1-10 and alemtuzumab subcutaneously SC on days 1 4 and 7 Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission CR proceed to consolidation therapy
CONSOLIDATION THERAPY Patients receive methotrexate IV on day 1 and asparaginase IM on day 2 Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients who remain in CR proceed to cytoreduction therapy
CYTOREDUCTION THERAPY Patients receive vincristine IV and methotrexate IV over 6 hours on day 1 leucovorin calcium IV continuously over 24 hours on days 1 and 2 and then orally 4 times a day on day 3 and oral dexamethasone on days 2-6 Treatment repeats every 30 days for 12 courses in the absence of disease progression or unacceptable toxicity Patients who remain in CR proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive oral mercaptopurine on days 1-30 oral methotrexate on days 1 8 15 and 22 vincristine IV on day 1 and oral dexamethasone on days 1-5 Treatment repeats every 30 days for 36 courses in the absence of disease progression or unacceptable toxicity
Patients are assessed every 3 months if patient is 2 years from study entry and every 6 months if patient is 2-5 years from study entry
PROJECTED ACCRUAL Allowing for two dose levels a maximum of 48 patients may be accrued approximately in 30 months
I Determine the complete response rate in patients with relapsed or refractory acute lymphoblastic leukemia treated with methotrexate vincristine asparaginase and dexamethasone MOAB in combination with alemtuzumab
II Determine disease-free andor overall survival of patients treated with this regimen
III Determine the toxic effects of this regimen in these patients
IV Correlate the density of cluster of differentiation 52 CD52 molecules on the surface of leukemic lymphoblasts with response in patients treated with this regimen
V Correlate the presence of minimal residual disease at the time of maximal response to this regimen with overall outcome in these patients
OUTLINE This is a multicenter study The study had two steps Step 1 5 mg dose of Campath alemtuzumab Step 2 10 mg dose of Campath
INDUCTION THERAPY Patients receive methotrexate intravenously IV on day 1 vincristine IV and asparaginase intramuscularly IM on day 2 oral dexamethasone on days 1-10 and alemtuzumab subcutaneously SC on days 1 4 and 7 Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission CR proceed to consolidation therapy
CONSOLIDATION THERAPY Patients receive methotrexate IV on day 1 and asparaginase IM on day 2 Treatment repeats every 10 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients who remain in CR proceed to cytoreduction therapy
CYTOREDUCTION THERAPY Patients receive vincristine IV and methotrexate IV over 6 hours on day 1 leucovorin calcium IV continuously over 24 hours on days 1 and 2 and then orally 4 times a day on day 3 and oral dexamethasone on days 2-6 Treatment repeats every 30 days for 12 courses in the absence of disease progression or unacceptable toxicity Patients who remain in CR proceed to maintenance therapy
MAINTENANCE THERAPY Patients receive oral mercaptopurine on days 1-30 oral methotrexate on days 1 8 15 and 22 vincristine IV on day 1 and oral dexamethasone on days 1-5 Treatment repeats every 30 days for 36 courses in the absence of disease progression or unacceptable toxicity
Patients are assessed every 3 months if patient is 2 years from study entry and every 6 months if patient is 2-5 years from study entry
PROJECTED ACCRUAL Allowing for two dose levels a maximum of 48 patients may be accrued approximately in 30 months
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 |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group | httpsreporternihgovquickSearchU10CA021115 |
| E1904 | OTHER | None | None |