A Safety and Efficacy Study of Duvelisib in Relapsed/Refractory Follicular Lymphoma

NCT ID: NCT04707079

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2022-03-31

Brief Summary

This is a phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects diagnosed with follicular lymphoma (FL) that is relapsed or refractory to either chemotherapy or radioimmunotherapy (RIT).

Detailed Description

This is an open-label, single arm, multi-center clinical trial to evaluate the efficacy and safety of duvelisib administered to subjects who have been diagnosed with follicular lymphoma that is relapsed or refractory to either chemotherapy or RIT.

Subjects (n=57) will receive 25 mg duvelisib twice daily (BID) over the course of 28-day treatment cycles for up to 12 cycles.

After completing 12 treatment cycles of duvelisib, subjects may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 12 cycles, subjects must have evidence of response (CR, PR or SD) by the end of Cycle 12.

Conditions

Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duvelisib

Eligible subjects will be given duvelisib (15mg, 25mg), orally at a dose of 25 mg BID during each 28-day treatment cycle, for up to 12 cycles.

Group Type: EXPERIMENTAL

Duvelisib

Intervention Type: DRUG

Eligible subjects will be given duvelisib orally at a dose of 25 mg BID during each 28-day treatment cycle, for up to 12 cycles.

Interventions

Duvelisib

Eligible subjects will be given duvelisib orally at a dose of 25 mg BID during each 28-day treatment cycle, for up to 12 cycles.

Intervention Type: DRUG

Other Intervention Names

COPIKTRA

Eligibility Criteria

Inclusion Criteria

1. Subjects must have been fully informed and signed informed consent form.

2. Subjects must be adults (>/=18 years), male or female.

3. Subjects who have been defined as FL by histologic or cytologic diagnosis, and must have relapsed or been refractory (at least two prior regimens for FL).

4. Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT or MRI according to Lugano 2014 criteria.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

6. Adequate renal and hepatic function.

7. Women of childbearing potential must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test.

8. Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study, including 30 days after the last dose of duvelisib.

Exclusion Criteria

1. Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.

2. Known hypersensitivity to the study drug duvelisib or excipients.

3. Previous treatment with a PI3K inhibitor or BTK inhibitor.

4. Prior history of allogeneic hematopoietic stem cell transplant (HSCT).

5. Prior chemotherapy, cancer immunosuppressive therapy, radiotherapy or other investigational agents within 4 weeks before the first dose of study drug.

6. Symptomatic central nervous system (CNS) Lymphoma.

7. Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.

8. Human immunodeficiency virus (HIV) infection.

9. Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection.

10. Hepatitis B or hepatitis C Infection.

11. History of stroke, unstable angina, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.

12. Female subjects who are pregnant or breastfeeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Weili Zhao, PhD

Role: primary

zwl_trial@163.com

021-64370045

Other Identifiers

HE1801201901/PRO

Identifier Type: -

Identifier Source: org_study_id