Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-31 @ 10:55 PM
Study NCT ID:
NCT03359460
Status:
COMPLETED
Last Update Posted:
2021-10-19
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibrutinib and Lenalidomide in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Brian Jonas
Organization:
Study Overview
Official Title:
Phase I Trial of the Combination of Ibrutinib and Lenalidomide for the Treatment of Patients With MDS Who Have Failed or Refuse Standard Therapy
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 best dose of ibrutinib when giving together with lenalidomide in treating patients with myelodysplastic syndrome. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib and lenalidomide may work better in treating patients with myelodysplastic syndrome.
Detailed Description:
PRIMARY OBJECTIVES:
To determine the recommended Phase II dose (RP2D) for ibrutinib in combination with lenalidomide in patients with myelodysplastic syndrome (MDS).
SECONDARY OBJECTIVES:
To do an early assessment of the activity of the combination of ibrutinib and lenalidomide in patients with MDS.
TERTIARY OBJECTIVES:
To examine the pharmacodynamic and biological effects of the combination of ibrutinib and lenalidomide in MDS.
To determine the recommended Phase II dose (RP2D) for ibrutinib in combination with lenalidomide in patients with myelodysplastic syndrome (MDS).
SECONDARY OBJECTIVES:
To do an early assessment of the activity of the combination of ibrutinib and lenalidomide in patients with MDS.
TERTIARY OBJECTIVES:
To examine the pharmacodynamic and biological effects of the combination of ibrutinib and lenalidomide in MDS.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCDCC#265 | OTHER | UC Davis | View | |
| UCDCC#265 | OTHER | University of California Davis Comprehensive Cancer Center | View | |
| P30CA093373 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2017-01827 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |