Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00254423
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2005-11-14
Brief Title:
Dasatinib in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Therapy of Early Chronic Phase Chronic Myelogenous Leukemia CML With Dasatinib BMS-354825
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 randomized phase II trial studies how well dasatinib works in treating patients with early chronic phase chronic myelogenous leukemia Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVE
I To estimate the proportion of patients with previously-untreated chronic phase chronic myelogenous leukemia CML attaining major molecular response by 12 months of treatment with dasatinib
SECONDARY OBJECTIVES
I To estimate the proportion of patients with Philadelphia chromosome Ph-positive early chronic phase CML achieving a complete cytogenetic response after dasatinib therapy
II To evaluate the durations of hematologic cytogenetic and molecular response to dasatinib
III To define the time to progression and overall survival for patients with CML in early chronic phase treated with dasatinib
IV To evaluate the toxicity profile of dasatinib in patients with CML in early chronic phase
V To evaluate the probability of developing c-abl oncogene 1 non-receptor tyrosine kinase ABL mutations for patients with CML in early chronic phase treated with dasatinib
VI To analyze differences in response rates and in prognosis within different risk groups and patient characteristics
VII To assess correlation between trough concentration and pleural effusion VIII To assess the inhibition of platelet function and assess correlation between drug concentration and degree of platelet inhibition
IX To assess the effect of dasatinib therapy in bone metabolism as determined by changes in serum alkaline phosphatase bone specific isoenzyme and trabecular bone volume
X To evaluate symptom burden in patients with CML receiving dasatinib
EXPLORATORY OBJECTIVE
I To investigate the plasmaserum levels of specific micro ribonucleic acids miRNAs in CML patients receiving dasatinib as initial therapy for CML in chronic phase CP
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive dasatinib orally PO once daily QD for up to 15-18 years
ARM B Patients receive dasatinib PO twice daily BID for up to 15-18 years
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I To estimate the proportion of patients with previously-untreated chronic phase chronic myelogenous leukemia CML attaining major molecular response by 12 months of treatment with dasatinib
SECONDARY OBJECTIVES
I To estimate the proportion of patients with Philadelphia chromosome Ph-positive early chronic phase CML achieving a complete cytogenetic response after dasatinib therapy
II To evaluate the durations of hematologic cytogenetic and molecular response to dasatinib
III To define the time to progression and overall survival for patients with CML in early chronic phase treated with dasatinib
IV To evaluate the toxicity profile of dasatinib in patients with CML in early chronic phase
V To evaluate the probability of developing c-abl oncogene 1 non-receptor tyrosine kinase ABL mutations for patients with CML in early chronic phase treated with dasatinib
VI To analyze differences in response rates and in prognosis within different risk groups and patient characteristics
VII To assess correlation between trough concentration and pleural effusion VIII To assess the inhibition of platelet function and assess correlation between drug concentration and degree of platelet inhibition
IX To assess the effect of dasatinib therapy in bone metabolism as determined by changes in serum alkaline phosphatase bone specific isoenzyme and trabecular bone volume
X To evaluate symptom burden in patients with CML receiving dasatinib
EXPLORATORY OBJECTIVE
I To investigate the plasmaserum levels of specific micro ribonucleic acids miRNAs in CML patients receiving dasatinib as initial therapy for CML in chronic phase CP
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive dasatinib orally PO once daily QD for up to 15-18 years
ARM B Patients receive dasatinib PO twice daily BID for up to 15-18 years
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| NCI-2012-01317 | REGISTRY | None | None |
| NCI-2010-00440 | None | None | None |
| 2005-0422 | OTHER | M D Anderson Cancer Center | None |