Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070499
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2003-10-03
Brief Title:
Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib BMS-354825 NSC-732517 for Previously Untreated Patients With Chronic Myelogenous Leukemia CML in Chronic Phase
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To compare the molecular response rates as measured by the decrease in breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 BCR-ABL transcripts after 12 months of treatment in patients with previously untreated chronic myelogenous leukemia CML in chronic phase who are treated with either dasatinib 100 mgday or imatinib STI571 Gleevec imatinib mesylate 400 mgday
II To test whether increasing the dose of imatinib STI571 Gleevec from 400 mgday to 800 mgday increases the rate of molecular response as measured by the decrease in BCR-ABL transcripts after 12 months of treatment in patients with previously untreated CML in chronic phase
III To estimate rates of cytogenetic and hematologic responses to imatinib 400 mgday imatinib 800 mgday and dasatinib 100 mgday
IV To evaluate in a preliminary manner the prognostic effects of derivative der9 and der22 chromosomal deletions for response in CML patients treated with imatinib and dasatinib
V To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment
VI To estimate the frequency and severity of toxicities of the three treatment regimens
VII To evaluate in a preliminary manner the overall survival and relapse-free survival of patients treated with these regimens
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive imatinib mesylate orally PO once daily QD Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity
ARM II Patients receive imatinib mesylate PO twice daily BID Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity
ARM III Patients receive dasatinib PO BID Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 15 years
I To compare the molecular response rates as measured by the decrease in breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 BCR-ABL transcripts after 12 months of treatment in patients with previously untreated chronic myelogenous leukemia CML in chronic phase who are treated with either dasatinib 100 mgday or imatinib STI571 Gleevec imatinib mesylate 400 mgday
II To test whether increasing the dose of imatinib STI571 Gleevec from 400 mgday to 800 mgday increases the rate of molecular response as measured by the decrease in BCR-ABL transcripts after 12 months of treatment in patients with previously untreated CML in chronic phase
III To estimate rates of cytogenetic and hematologic responses to imatinib 400 mgday imatinib 800 mgday and dasatinib 100 mgday
IV To evaluate in a preliminary manner the prognostic effects of derivative der9 and der22 chromosomal deletions for response in CML patients treated with imatinib and dasatinib
V To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment
VI To estimate the frequency and severity of toxicities of the three treatment regimens
VII To evaluate in a preliminary manner the overall survival and relapse-free survival of patients treated with these regimens
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive imatinib mesylate orally PO once daily QD Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity
ARM II Patients receive imatinib mesylate PO twice daily BID Treatment repeats every 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity
ARM III Patients receive dasatinib PO BID Treatment repeats every 4 weeks for up to 5 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 15 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 |
|---|---|---|---|
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |
| NCI-2009-00764 | REGISTRY | None | None |
| S0325 | None | None | None |
| S0325 | OTHER | None | None |
| S0325 | OTHER | None | None |
| U10CA180888 | NIH | None | None |