Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327262
Status:
UNKNOWN
Last Update Posted:
2006-06-20
First Post:
2006-05-16
Brief Title:
Comparing Imatinib Standard Dose With Imatinib High Dose Induction in Pretreated Chronic Myeloid Leukemia CML Patients in Chronic Phase
Sponsor:
Central European Leukemia Study Group
Organization:
Central European Leukemia Study Group
Study Overview
Official Title:
Multicenter Phase III Study Comparing Imatinib STI571 Glivec Standard Dose 400 MgDay With Imatinib High Dose Induction 800 MgDay Followed by Standard Dose Maintenance 400 MgDay in Pretreated CML Patients in Chronic Phase
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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 study will investigate the efficacy and tolerability of a short 6 months high dose therapy followed by a standard dose compared to a continuous treatment with a standard dose of imatinib Glivec in pretreated Philadelphia chromosome- positive PhBCR-ABL CML patients in chronic phase
Detailed Description:
Patients with CML not achieving or losing a major cytogenetic response on whatever palliative treatment for CML are at high risk to progress to accelerated phase and blast crisis A new promising treatment with Imatinib Glivec a tyrosine-kinase inhibitor has been introduced recently High rates of hematologic and cytogenetic responses can be achieved with Imatinib Glivec at 300 mgday in chronic phase CML patients that are refractory resistant or intolerant to interferon-alpha However about 10 - 20 of these high risk patients will lose their response to Imatinib Glivec within 1-2 years Therefore improvement of the treatment is warranted
Since cytogenetic response rate is correlated to survival and the resistance to Imatinib Glivec might be caused by mutations in the receptor a more rapid decrease could lead to longer survival andor less resistance development In the initial 6 months of treatment monotherapy with Imatinib Glivec with a dose of 800 mgday high dose should be more effective in the reduction of a high leukemic tumor burden thereby allowing the residual normal progenitor and stem cells to expand In addition high dose Imatinib Glivec should further improve the induction of a molecular response as determined by quantitative reverse transcription polymerase chain reaction RT-PCR reducing the risk of relapse from residual malignant BCR-ABL positive cells
This study will investigate the efficacy and tolerability of a short 6 months high dose therapy followed by a standard dose compared to a continuous treatment with a standard dose of Imatinib Glivec
In addition the dynamics of the molecular and cytogenetic response will be investigated Finally the study will investigate the effect of this induction-maintenance concept on time-to-progression TTP
Since cytogenetic response rate is correlated to survival and the resistance to Imatinib Glivec might be caused by mutations in the receptor a more rapid decrease could lead to longer survival andor less resistance development In the initial 6 months of treatment monotherapy with Imatinib Glivec with a dose of 800 mgday high dose should be more effective in the reduction of a high leukemic tumor burden thereby allowing the residual normal progenitor and stem cells to expand In addition high dose Imatinib Glivec should further improve the induction of a molecular response as determined by quantitative reverse transcription polymerase chain reaction RT-PCR reducing the risk of relapse from residual malignant BCR-ABL positive cells
This study will investigate the efficacy and tolerability of a short 6 months high dose therapy followed by a standard dose compared to a continuous treatment with a standard dose of Imatinib Glivec
In addition the dynamics of the molecular and cytogenetic response will be investigated Finally the study will investigate the effect of this induction-maintenance concept on time-to-progression TTP
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