Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-27 @ 6:21 AM
Study NCT ID:
NCT01426334
Status:
TERMINATED
Last Update Posted:
2014-04-02
First Post:
2011-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dasatinib and Cyclosporine in Treating Patients With Chronic Myelogenous Leukemia Refractory or Intolerant to Imatinib Mesylate
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Exploiting Synergy in Chronic Myelogenous Leukemia: A Phase Ib Evaluation of Dasatinib Plus Cyclosporine in Patients With Ph+ Leukemia (ESCAPE1b)
Status:
TERMINATED
Status Verified Date:
2013-06
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 phase I trial studies the side effects and the best way to give dasatinib and cyclosporine in treating patients with chronic myelogenous leukemia (CML) refractory or intolerant to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine may be an effective treatment for CML.
Detailed Description:
PRIMARY OBJECTIVES:
I. To define the safety and tolerability of cyclosporine A in combination with dasatinib in adults with Bcr-Abl+ chronic myelogenous leukemia in chronic phase, or when used in specified patients with accelerated phase CML.
SECONDARY OBJECTIVES:
I. To assess pharmacokinetic parameters of dasatinib when combined with cyclosporine.
II. To assess whether the combination of dasatinib and cyclosporine alters T cell number and function.
III. To assess the feasibility of determining phosphorylation of Src in peripheral blood mononuclear cells by flow cytometry as a surrogate measure of dasatinib activity.
OUTLINE:
Patients receive dasatinib orally (PO) once daily (QD) on days 1-28 and cyclosporine PO twice daily (BID) on days 8-28. Treatment repeats every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
Patients undergo peripheral blood sample collection at baseline and periodically during treatment for pharmacokinetic and pharmacodynamic studies and T-cell number and function by flow cytometry.
After completion of study treatment, patients are followed up for 4 weeks.
I. To define the safety and tolerability of cyclosporine A in combination with dasatinib in adults with Bcr-Abl+ chronic myelogenous leukemia in chronic phase, or when used in specified patients with accelerated phase CML.
SECONDARY OBJECTIVES:
I. To assess pharmacokinetic parameters of dasatinib when combined with cyclosporine.
II. To assess whether the combination of dasatinib and cyclosporine alters T cell number and function.
III. To assess the feasibility of determining phosphorylation of Src in peripheral blood mononuclear cells by flow cytometry as a surrogate measure of dasatinib activity.
OUTLINE:
Patients receive dasatinib orally (PO) once daily (QD) on days 1-28 and cyclosporine PO twice daily (BID) on days 8-28. Treatment repeats every 28 days for 4 months in the absence of disease progression or unacceptable toxicity.
Patients undergo peripheral blood sample collection at baseline and periodically during treatment for pharmacokinetic and pharmacodynamic studies and T-cell number and function by flow cytometry.
After completion of study treatment, patients are followed up for 4 weeks.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-03454 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000709681 | None | None | View | |
| 10-1401 | None | None | View | |
| 10-1401 | OTHER | University of Colorado Cancer Center - Anschutz Cancer Pavilion | View | |
| 8890 | OTHER | CTEP | View | |
| P30CA046934 | NIH | None | https://reporter.nih.gov/quic… | View |