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

Phase 2

Withdrawn

• Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia
• Interventions: Drug: Duvelisib

• Registration Number: NCT03370185
• Lead Sponsor: SecuraBio

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-12
• Study Start: 2018-02-12
• Primary Completion: 2020-06
• Study Completion: 2021-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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:

   1. Progressive disease (PD) while receiving or within 6 months after completing BTKi therapy.
   2. Discontinued a BTKi therapy due to BTKi treatment- related intolerance.

5. Measurable disease with a lymph node or tumor mass > 1.5 cm in at least one dimension.

6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

7. Resolution of toxicities due to prior BTKi therapy to acceptable level.

8. Willingness of male and female patients to use medically acceptable methods of birth control.

9. Willing and able to participate in all required study evaluations and procedures.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	From start of treatment to first documented response, 2 cycles (58 days)

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR), defined as CR/CRi + PR/PRwL + stable disease (SD) ≥ 8 weeks	Greater than or equal to 8 weeks
Treatment-Emergent adverse events (TEAEs) and changes in laboratory values	From start of treatment to end of treatment plus 30 days; 7 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
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

Trial Locations

Locations (8)

St. Vincent Frontier Cancer Center; 🇺🇸 Billings, Montana, United States

Ingalls Memorial Hospital; 🇺🇸 Harvey, Illinois, United States

Genesis Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

Arizona Oncology; 🇺🇸 Tempe, Arizona, United States

Moores UC San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

QUEST Research Institute; 🇺🇸 Royal Oak, Michigan, United States

Summit Medical Group; 🇺🇸 Morristown, New Jersey, United States

Medical Oncology Associates PS, WA; 🇺🇸 Spokane, Washington, United States