Spots Global Cancer Trial Database for Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia

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Trial Identification

Brief Title: Ruxolitinib for the Treatment of T-Cell Large Granular Lymphocytic Leukemia

Official Title: A Phase II Study Evaluating the Efficacy of Ruxolitinib in Patients With T-Cell Large Granular Lymphocytic Leukemia (T-LGLL)

Study ID: NCT05592015

Conditions

T-Cell Large Granular Lymphocyte Leukemia

Interventions

Ruxolitinib

Study Description

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 Description: 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.