Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Thomas Kipps

Description

Summary

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.

Official Title

A Phase 2 Study of Duvelisib Efficacy and Safety in Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Previously Treated With a Bruton's Tyrosine Kinase Inhibitor (BTKi)

Keywords

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Leukemia Lymphoma Refractory Relapse Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Duvelisib

Eligibility

You can join if…

Open to people ages 18 years and up

  1. ≥ 18 years of age.
  2. Diagnosis of CLL or SLL.
  3. Received at least one prior anti-cancer therapy for CLL or SLL.
  4. Previous exposure to BTKi and meet at least one of the criteria below:
  5. Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
  6. Discontinued a BTKi therapy due to BTKi treatment- related intolerance.
  7. Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.
  8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  9. Resolution of toxicities due to prior BTKi therapy to acceptable level.
  10. Willingness of male and female patients to use medically acceptable methods of birth control.
  11. Willing and able to participate in all required study evaluations and procedures.

You CAN'T join if...

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

Locations

  • Moores UC San Diego Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Arizona Oncology accepting new patients
    Tempe Arizona 85284 United States
  • St. Vincent Frontier Cancer Center accepting new patients
    Billings Montana 59102 United States
  • Medical Oncology Associates PS, WA accepting new patients
    Spokane Washington 99208 United States
  • Genesis Cancer Center accepting new patients
    Hot Springs Arkansas 71913 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Verastem, Inc.
ID
NCT03370185
Phase
Phase 2
Lead Scientist
Thomas Kipps
Study Type
Interventional
Last Updated
August 3, 2018