Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT04230304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2020-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Phase II Study of Daratumumab and Ibrutinib for Relapsed / Refractory Chronic Lymphocytic Leukemia Treatment (DIRECT)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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 II trial studies how well daratumumab and ibrutinib work in treating patients with chronic lymphocytic leukemia that has come back (relapsed) or has not responded to previous treatment (refractory). Daratumumab is a monoclonal antibody which works with the body's immune system to destroy cancer cells. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving daratumumab and ibrutinib may work better in treating patients with chronic lymphocytic leukemia compared to ibrutinib alone.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are on /or are previously treated with ibrutinib. (Cohort 1) II. Determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are naive to ibrutinib treatment. (Cohort 2)
SECONDARY OBJECTIVES:
I. Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy. (Cohort 1) II. The overall incidence of MRD (minimal residual disease) negative state and the time to achieving MRD negativity at any time during this therapy. (Cohort 1) III. Progression free survival (as determined by the International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] criteria) among all patients. (Cohort 1) IV. The overall toxicity profile of daratumumab/ibrutinib treatment in this group of patients. (Cohort 1) V. Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy. (Cohort 2) VI. The overall incidence of MRD (minimal residual disease) negative state and the time to achieving MRD negativity at any time during this therapy. (Cohort 2) VII. The overall toxicity profile of daratumumab/ibrutinib treatment in this group of patients. (Cohort 2)
OUTLINE:
Patients receive daratumumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and then on day 1 of subsequent cycles. Beginning in cycle 2, patients also receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study registration, patients are followed up periodically for up to 5 years.
I. Determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are on /or are previously treated with ibrutinib. (Cohort 1) II. Determine the overall response rate after 6 cycles of treatment with daratumumab in combination with ibrutinib in patients who are naive to ibrutinib treatment. (Cohort 2)
SECONDARY OBJECTIVES:
I. Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy. (Cohort 1) II. The overall incidence of MRD (minimal residual disease) negative state and the time to achieving MRD negativity at any time during this therapy. (Cohort 1) III. Progression free survival (as determined by the International Workshop on Chronic Lymphocytic Leukemia \[IWCLL\] criteria) among all patients. (Cohort 1) IV. The overall toxicity profile of daratumumab/ibrutinib treatment in this group of patients. (Cohort 1) V. Determine the best overall response rate to treatment with daratumumab plus ibrutinib at any time during the course of the therapy. (Cohort 2) VI. The overall incidence of MRD (minimal residual disease) negative state and the time to achieving MRD negativity at any time during this therapy. (Cohort 2) VII. The overall toxicity profile of daratumumab/ibrutinib treatment in this group of patients. (Cohort 2)
OUTLINE:
Patients receive daratumumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2, on days 1 and 15 of cycles 3-6, and then on day 1 of subsequent cycles. Beginning in cycle 2, patients also receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study registration, patients are followed up periodically for up to 5 years.
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?:
None
Is an FDA AA801 Violation?: