Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma

Withdrawn before enrolling · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.

Key facts

Study ID

NCT03370185

Run by

SecuraBio

People needed

0

Starts

2018-02-12

Expected to finish

2021-03-01

Last updated by the study team

2023-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age.
• Diagnosis of CLL or SLL.
• Received at least one prior anti-cancer therapy for CLL or SLL.
• Previous exposure to BTKi and meet at least one of the criteria below:
• Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
• Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
• Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Resolution of toxicities due to prior BTKi therapy to acceptable level.
• Willingness of male and female patients to use medically acceptable methods of birth control.
• Willing and able to participate in all required study evaluations and procedures.

You may not qualify if…

• Richter's transformation or prolymphocytic leukemia
• Uncontrolled autoimmune hemolytic anemia or thrombocytopenia
• Received prior transplant
• Experienced PD or serious adverse events on a prior phosphoinositide-3-kinase (PI3K) inhibitor
• Known central nervous system involvement by CLL/SLL

Where it is running

• Arizona Oncology — Tempe, Arizona, United States
• Genesis Cancer Center — Hot Springs, Arkansas, United States
• Moores UC San Diego Cancer Center — La Jolla, California, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• QUEST Research Institute — Royal Oak, Michigan, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• Summit Medical Group — Morristown, New Jersey, United States
• Medical Oncology Associates PS, WA — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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