Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390793
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2006-10-18
Brief Title:
Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia Ph Chromosome Positive andor BCR-ABL Positive Acute Lymphoblastic Leukemia ALL
Status:
COMPLETED
Status Verified Date:
2024-01
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 studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia Drugs used in chemotherapy such as cyclophosphamide vincristine doxorubicin dexamethasone methotrexate and cytarabine work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the clinical efficacy event-free survival of an intensive short-term chemotherapy regimen Hyper- cyclophosphamide vincristine doxorubicin dexamethasone CVAD program given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia Ph-positive andor B-cell receptor BCR-ABL-positive acute lymphoblastic leukemia ALL
II To evaluate other clinical efficacy overall response rate and survival and safety of an intensive short-term chemotherapy regimen Hyper-CVAD program given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia Ph-positive andor BCR-ABL-positive acute lymphoblastic leukemia ALL
OUTLINE
HYPER-CVAD THERAPY Participants receive cyclophosphamide intravenously IV twice daily BID over 3 hours on days 1-3 vincristine IV over 30 minutes on days 4 and 11 and doxorubicin IV over 24-48 hours on day 4 Participants also receive dexamethasone orally PO or IV over 30 minutes on days 1-4 and 11-14 and dasatinib PO once daily QD on days 1-14 of course 1 and on days 1-21 for subsequent courses Courses repeat every 21 days for up to 4 odd courses 1 3 5 and 7 in the absence of disease progression or unacceptable toxicity
METHOTREXATE PLUS CYTARABINE Participants receive methotrexate IV over 24 hours on day 1 dasatinib PO on days 1-21 and cytarabine IV BID over 2 hours on days 2 and 3 Courses repeat every 21 days for up to 4 even courses 2 4 6 and 8 in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Participants receive vincristine IV over 30 minutes on day 1 prednisone PO on days 1-5 and dasatinib PO BID Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity During courses 6 and 13 participants may receive an additional course of hyper-CVAD therapy
After completion of study treatment participants are followed for up to 12 months
I To evaluate the clinical efficacy event-free survival of an intensive short-term chemotherapy regimen Hyper- cyclophosphamide vincristine doxorubicin dexamethasone CVAD program given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia Ph-positive andor B-cell receptor BCR-ABL-positive acute lymphoblastic leukemia ALL
II To evaluate other clinical efficacy overall response rate and survival and safety of an intensive short-term chemotherapy regimen Hyper-CVAD program given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia Ph-positive andor BCR-ABL-positive acute lymphoblastic leukemia ALL
OUTLINE
HYPER-CVAD THERAPY Participants receive cyclophosphamide intravenously IV twice daily BID over 3 hours on days 1-3 vincristine IV over 30 minutes on days 4 and 11 and doxorubicin IV over 24-48 hours on day 4 Participants also receive dexamethasone orally PO or IV over 30 minutes on days 1-4 and 11-14 and dasatinib PO once daily QD on days 1-14 of course 1 and on days 1-21 for subsequent courses Courses repeat every 21 days for up to 4 odd courses 1 3 5 and 7 in the absence of disease progression or unacceptable toxicity
METHOTREXATE PLUS CYTARABINE Participants receive methotrexate IV over 24 hours on day 1 dasatinib PO on days 1-21 and cytarabine IV BID over 2 hours on days 2 and 3 Courses repeat every 21 days for up to 4 even courses 2 4 6 and 8 in the absence of disease progression or unacceptable toxicity
MAINTENANCE THERAPY Participants receive vincristine IV over 30 minutes on day 1 prednisone PO on days 1-5 and dasatinib PO BID Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity During courses 6 and 13 participants may receive an additional course of hyper-CVAD therapy
After completion of study treatment participants are followed for up to 12 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-0478 | OTHER | M D Anderson Cancer Center | None |
| NCI-2018-01846 | REGISTRY | None | None |