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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04781855
Other study ID # 2020-0571
Secondary ID NCI-2020-1416120
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date July 14, 2022
Est. completion date December 31, 2024

Study information

Verified date November 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/Ib 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 body's 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.


Description:

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Study Design


Related Conditions & MeSH terms

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Recurrence
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
  • Richter Syndrome

Intervention

Drug:
Ibrutinib
Given PO
Biological:
Ipilimumab
Given IV
Nivolumab
Given IV

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose of ipilimumab Up to 2 years
Primary Dose limiting toxicities DLT is defined as clinically significant non-hematologic adverse event or abnormal laboratory value assessed as unrelated to disease, intercurrent illness, or concomitant medications and occurring during the first 21 days. During first 21 days on study intervention
Secondary Overall response rate Defined as complete response (CR) + complete response with incomplete marrow recovery (CRi) + partial response (PR). Response will be assessed by the investigator, based on physical examinations, computed tomography scans, laboratory results, and bone marrow examinations, according to the modified 2008 International Workshop on Chronic Lymphocytic Leukemia response criteria for chronic lymphocytic leukemia. The overall response rate (i.e., CR/CRi/PR) will be estimated along with the exact 95% confidence interval. Up to 2 years
Secondary Progression-free survival Assessed using Kaplan-Meier method. From treatment start date until the date of disease progression date or death due to any cause, whichever occurred first, assessed up to 2 years
Secondary Overall survival Assessed using Kaplan-Meier method. From treatment start date until the date of death due to any cause, assessed up to 2 years
Secondary Incidence of adverse events Will be summarized by treatment, category, severity and attribution. Up to 2 years
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