Clinical Trial: Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: A Phase II Study Evaluating the Efficacy of Ruxolitinib in Patients With T-Cell Large Granular Lymphocytic Leukemia (T-LGLL)
Brief Summary: This phase II trial tests whether ruxolitinib works to shrink tumors in patients with T-cell large granular lymphocyte leukemia.
Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Summary:
PRIMARY OBJECTIVE:
I. Determine the overall response rate (ORR) of ruxolitinib in patients with T-cell large granular lymphocytic leukemia (T-LGLL) as compared to historical controls.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (complete response [CR] and partial response [PR]) of ruxolitinib in patients with T-LGLL.
II. Duration of response to ruxolitinib.
III.
Leukemia-free survival.
IV.
Rate of conversion from PR at 4 months to CR at 8 and 12 months (at full ruxolitinib dosage).
V. Rate of molecular remission (T-cell receptor [TCR] clearance, STAT3 mutation clearance) at 4, 8, 12 months.
VI. Incidence of grade III/IV toxicities (at full ruxolitinib dosage).
VII.
Quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), Health Assessment Questionnaire-Disability Index (HAQDi), Short Form (SF)-36 questionnaire at baseline, after 5 months, 1 year of treatment.
EXPLORATORY OBJECTIVE:
I. Objective benefit (OB) rate at 4 months defined as a patient that had improvement in their cytopenias, transfusion dependence but not attaining a PR.
OUTLINE:
Patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-28.
Cycles repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
Patients who achieve a response (CR or PR) may receive an additional 12 months of ruxolitinib, for a maximum of 24 months.
Sponsor: John Reneau
Current Primary Outcome: The ORR will be calculated as the proportion of patients who achieve a response to therapy divided by the total number of evaluable patients.
An evaluable patient is defined as an eligible patient who has received at least four months of therapy with ruxolitinib.
All evaluable patients will be included in calculating the ORR for the study along with corresponding 95% binomial confidence intervals (CIs) (assuming that the number of patients who respond is binomially distributed).
Additional outcomes including rates of conversion from PR at 4 months to CR at 8 and 12 months on full dose ruxolitinib, and rate of molecular remission (TCR clearance, STAT3 mutation clearance) at 4, 8, 12 months on full dose ruxolitinib will also be reported as proportions with 95% binomial CIs.
Original Primary Outcome: The ORR will be calculated as the proportion of patients who achieve a response to therapy divided by the total number of evaluable patients.
An evaluable patient is defined as an eligible patient who has received at least four months of therapy with ruxolitinib.
All evaluable patients will be included in calculating the ORR for the study along with corresponding 95% binomial confidence intervals (CIs) (assuming that the number of patients who respond is binomially distributed).
Additional outcomes including rates of conversion from PR at 4 months to CR at 8 and 12 months on full dose ruxolitinib, and rate of molecular remission (TCR clearance, STAT3 mutation clearance) at 4, 8, 12 months on full dose ruxolitinib will also be reported as proportions with 95% binomial CIs.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Ohio State University Comprehensive Cancer Center
Dates:
Date Received: April 18, 2022
Date Started: May 03, 2023
Date Completion: May 03, 2023
Last Updated: October 30, 2023
Last Verified: October 01, 2023
