Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781855
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-02-24
Brief Title:
Ipilimumab Ibrutinib and Nivolumab for the Treatment of Chronic Lymphocytic Leukemia and Richter Transformation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Ipilimumab Combined With Ibrutinib and Nivolumab for Patients With Chronic Lymphocytic Leukemia CLL and Richter Transformation RT
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 IIb trial evaluates the best dose and side effects of ipilimumab in combination with either ibrutinib alone or with ibrutinib and nivolumab in treating patients with chronic lymphocytic leukemia CLL and Richter transformation RT Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the bodys immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving ipilimumab with either ibrutinib alone or with ibrutinib and nivolumab may help control CLL and RT
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD and dose limiting toxicity DLT of ipilimumab in combination with ibrutinib in patients with CLLsmall lymphocytic lymphoma SLLRT Part A II To determine the MTD and DLT of ipilimumab in combination with nivolumab and ibrutinib in patients with CLLSLLRT Part B
SECONDARY OBJECTIVES
I To determine the efficacy response rate defined as complete response CR complete response with incomplete marrow recovery CRi partial response PR of the combination therapy
II To determine the progression-free survival and overall survival of the combination therapy
EXPLORATORY OBJECTIVE
I To study immunological and molecular changes in peripheral blood lymph node and bone marrow in response to the combination therapy
OUTLINE This is a dose-escalation study of ipilimumab followed by a dose-expansion study Patients are assigned to 1 of 2 parts
PART A Patients receive ipilimumab intravenously IV over 90 minutes on day 1 Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity Beginning day 1 of cycle 1 patients also receive ibrutinib orally PO once daily QD in the absence of disease progression or unacceptable toxicity Patients who complete 4 doses of ipilimumab and are deriving benefit from it without severe toxicities may continue to receive ipilimumab every 12 weeks for up to a total of 2 years
PART B Patients receive ipilimumab IV over 90 minutes and nivolumab IV over 30 minutes on day 1 Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity Beginning day 7 of cycle 1 patients also receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity Patients who complete 4 doses of ipilimumab and nivolumab and are deriving benefit from it without severe toxicities may continue to receive ipilimumab every 12 weeks and nivolumab every 4 weeks for up to a total of 2 years
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
I To determine the maximum tolerated dose MTD and dose limiting toxicity DLT of ipilimumab in combination with ibrutinib in patients with CLLsmall lymphocytic lymphoma SLLRT Part A II To determine the MTD and DLT of ipilimumab in combination with nivolumab and ibrutinib in patients with CLLSLLRT Part B
SECONDARY OBJECTIVES
I To determine the efficacy response rate defined as complete response CR complete response with incomplete marrow recovery CRi partial response PR of the combination therapy
II To determine the progression-free survival and overall survival of the combination therapy
EXPLORATORY OBJECTIVE
I To study immunological and molecular changes in peripheral blood lymph node and bone marrow in response to the combination therapy
OUTLINE This is a dose-escalation study of ipilimumab followed by a dose-expansion study Patients are assigned to 1 of 2 parts
PART A Patients receive ipilimumab intravenously IV over 90 minutes on day 1 Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity Beginning day 1 of cycle 1 patients also receive ibrutinib orally PO once daily QD in the absence of disease progression or unacceptable toxicity Patients who complete 4 doses of ipilimumab and are deriving benefit from it without severe toxicities may continue to receive ipilimumab every 12 weeks for up to a total of 2 years
PART B Patients receive ipilimumab IV over 90 minutes and nivolumab IV over 30 minutes on day 1 Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity Beginning day 7 of cycle 1 patients also receive ibrutinib PO QD in the absence of disease progression or unacceptable toxicity Patients who complete 4 doses of ipilimumab and nivolumab and are deriving benefit from it without severe toxicities may continue to receive ipilimumab every 12 weeks and nivolumab every 4 weeks for up to a total of 2 years
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-0571 | OTHER | M D Anderson Cancer Center | None |
| NCI-2020-14161 | REGISTRY | None | None |