Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01888952
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2013-05-08
Brief Title:
Phase 01 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies CTRC 13-0013
Sponsor:
Anand B Karnad
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Phase 01 Biomarker and Pharmacodynamic Study of Roflumilast in Patients With Advanced B-Cell Hematologic Malignancies CTRC 13-0013
Status:
COMPLETED
Status Verified Date:
2017-01
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 is a Phase 01 open-label non-randomized biomarker and pharmacodynamic study in patients with advanced B-cell lymphoid malignancies including B-cell chronic lymphocytic leukemia CLL small lymphocytic lymphoma SLL acute lymphocytic leukemia ALL multiple myeloma MM Waldenströms macroglobulinemia WM mantle cell lymphoma follicular lymphoma or diffuse large B-cell lymphoma DLBCL who have failed at least one prior therapy and for whom no standard curative therapy exists Patients with advanced stage disease are those whose disease is resistant or refractory to standard chemotherapy or biological therapies
Detailed Description:
This pilot study will evaluate whether the administration of roflumilast inhibits the activity of PDE4 and results in the modulation of AKTmTOR pathways in patients with B-cell hematologic malignancies Peripheral blood samples will be collected for the purpose of determining the pharmacodynamics of roflumilast on PDE4 activity and on biomarkers as related to GC resistance Samples are obtained at baseline prior to starting study treatment on Day 8 before the administration of the Day 8 study drugs prednisone and roflumilast and on Day 15 If a bone marrow biopsy is also performed prior to study treatment or at any time during treatment a sample will be sent for analysis Normal PBMC and bone marrow when it is obtained will be examined for changes in key targets related to the inhibition of PDE4 and potential reversal of glucocorticoid resistance Biomarker blood samples will be analyzed in order to characterize the pharmacodynamics of roflumilast alone and in combination with prednisone on PDE4 activity and on biomarkers such as phospho-AKT phosphorylation levels of mTOR targets
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 |
|---|---|---|---|
| HSC20130307H | OTHER | University of Texas Health Science Center San Antonio IRB UTHSCSA | None |