Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT01886859
Status:
COMPLETED
Last Update Posted:
2022-09-26
First Post:
2013-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lenalidomide and Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Dose Escalation Study of Ibrutinib With Lenalidomide for Relapsed and Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Status:
COMPLETED
Status Verified Date:
2022-09
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 best dose of lenalidomide when given together with ibrutinib in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide together with ibrutinib may work better in treating chronic lymphocytic leukemia or small lymphocytic lymphoma.
Detailed Description:
PRIMARY OBJECTIVE:
I. To define the safety, tolerability and maximum tolerated dose (MTD) of lenalidomide when used in combination with ibrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
SECONDARY OBJECTIVES:
I. To determine the response rate and response duration in relapsed and refractory CLL/SLL patients with ibrutinib and lenalidomide.
II. To characterize the plasma pharmacokinetic (PK) interaction between ibrutinib and lenalidomide.
III. To explore whether pharmacogenetic studies can predict response, resistance or toxicity to ibrutinib and lenalidomide.
IV. To explore the ability of ibrutinib to occupy its targets (Bruton's tyrosine kinase \[BTK\] in B-cells and interleukin-2 inducible kinase \[ITK\] in T-cells), and whether co-administration with lenalidomide influences this binding.
V. To explore the early and late immunologic consequences of combining ibrutinib with lenalidomide in relapsed and refractory CLL.
VI. To explore the impact of ibrutinib and lenalidomide on ras homolog family member H (RhoH) expression and whether baseline RhoH expression predicts outcomes with this regimen.
VII. To explore mechanisms of resistance to ibrutinib. VIII. To explore the influence of traditional and new CLL/SLL clinical and laboratory prognostic factors on response to ibrutinib and lenalidomide.
OUTLINE: This is a dose-escalation study of lenalidomide.
Patients receive a run-up cycle of ibrutinib orally (PO) daily on days 1-28. Patients then receive ibrutinib PO and lenalidomide PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients who have achieved complete remission (CR)/CR with incomplete marrow recovery (CRi), nodular partial remission (PR), partial remission with persistent lymphocytosis, partial remission, or who have stable disease discontinue lenalidomide and continue ibrutinib.
After completion of study treatment, patients are followed up for 90 days.
I. To define the safety, tolerability and maximum tolerated dose (MTD) of lenalidomide when used in combination with ibrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
SECONDARY OBJECTIVES:
I. To determine the response rate and response duration in relapsed and refractory CLL/SLL patients with ibrutinib and lenalidomide.
II. To characterize the plasma pharmacokinetic (PK) interaction between ibrutinib and lenalidomide.
III. To explore whether pharmacogenetic studies can predict response, resistance or toxicity to ibrutinib and lenalidomide.
IV. To explore the ability of ibrutinib to occupy its targets (Bruton's tyrosine kinase \[BTK\] in B-cells and interleukin-2 inducible kinase \[ITK\] in T-cells), and whether co-administration with lenalidomide influences this binding.
V. To explore the early and late immunologic consequences of combining ibrutinib with lenalidomide in relapsed and refractory CLL.
VI. To explore the impact of ibrutinib and lenalidomide on ras homolog family member H (RhoH) expression and whether baseline RhoH expression predicts outcomes with this regimen.
VII. To explore mechanisms of resistance to ibrutinib. VIII. To explore the influence of traditional and new CLL/SLL clinical and laboratory prognostic factors on response to ibrutinib and lenalidomide.
OUTLINE: This is a dose-escalation study of lenalidomide.
Patients receive a run-up cycle of ibrutinib orally (PO) daily on days 1-28. Patients then receive ibrutinib PO and lenalidomide PO daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients who have achieved complete remission (CR)/CR with incomplete marrow recovery (CRi), nodular partial remission (PR), partial remission with persistent lymphocytosis, partial remission, or who have stable disease discontinue lenalidomide and continue ibrutinib.
After completion of study treatment, patients are followed up for 90 days.
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 |
|---|---|---|---|---|
| 9254 | OTHER | University of Colorado Hospital | View | |
| 9254 | OTHER | CTEP | View | |
| P30CA046934 | NIH | None | https://reporter.nih.gov/quic… | View |
| P50CA140158 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA076576 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186688 | NIH | None | https://reporter.nih.gov/quic… | View |
| UM1CA186712 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2013-00888 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 13-0110 | None | None | View | |
| 12-164 | None | None | View |