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

NCT03370185 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: VS-0145-224
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Keywords

Leukemia; Lymphoma; Refractory; Relapse

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  From start of treatment to first documented response, 2 cycles (58 days)

Secondary Outcomes (4)

• Treatment-Emergent adverse events (TEAEs) and changes in laboratory values

  From start of treatment to end of treatment plus 30 days; 7 months

• Duration of response (DOR), defined as the time from the first documentation of response to the first documentation of PD or death due to any cause

  Time from the first documentation of response to first documentation of progressive disease or death due to any cause, 6 months

• Progression-free survival (PFS), defined as the time from the first dose of study treatment to the first documentation of PD or death from any cause

  Time from start of treatment to first documentation of progression or date of death from any cause, whichever came first, 4 months

• Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks

  Greater than or equal to 8 weeks

Study Arms (1)

Duvelisib

EXPERIMENTAL

Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles

Drug: Duvelisib

Interventions

Duvelisib DRUG

Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles

Duvelisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (8)

Arizona Oncology

Tempe, Arizona, 85284, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Moores UC San Diego Cancer Center

La Jolla, California, 92093, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

QUEST Research Institute

Royal Oak, Michigan, 48073, United States

Location

St. Vincent Frontier Cancer Center

Billings, Montana, 59102, United States

Location

Summit Medical Group

Morristown, New Jersey, 07932, United States

Location

Medical Oncology Associates PS, WA

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Lymphoma; Recurrence

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 12, 2017
• Study Start: February 12, 2018
• Primary Completion: June 1, 2020
• Study Completion: March 1, 2021
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)