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

NCT04707079 | Unknown Phase 2 FDA Drug

• 1 other identifier: HE1801201901/PRO
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR),

  Defined as the best response of complete response/remission (CR) or partial response/remission (PR), according to the Cheson 2007 Criteria by Independent Review Committee (IRC)

  Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.

Secondary Outcomes (10)

• ORR assessed by study sites according to the Cheson 2007 Criteria;

  Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.

• ORR assessed respectively by study sites and IRC, according to the Lugano 2014 Criteria;

  Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.

• Treatment-emergent adverse events (TEAEs), ECG measures, and changes in safety laboratory values;

  Every 2-8 weeks; up to 30 days after the last dose of duvelisib.

• Duration of Response;

  Within 7 days prior to initiating the next cycle of study treatment (i.e. Day -7 to Day 1) of Cycles 3, 5, 7, 9 (each cycle is 28 days) and at every fourth cycle thereafter (Cycle 13, 17, 21, etc.) up to the end of treatment, an average of 8 months.

• Progression-free survival;

  Every 12 weeks; for an average response / progression follow-up of 2 years.

Study Arms (1)

Duvelisib

EXPERIMENTAL

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.

Drug: Duvelisib

Interventions

Duvelisib 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.

Also known as: COPIKTRA

Duvelisib

Eligibility Criteria

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

You may qualify if:

• Subjects must have been fully informed and signed informed consent form.
• Subjects must be adults (\>/=18 years), male or female.
• 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).
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate renal and hepatic function.
• Women of childbearing potential must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test.
• 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.

You may not qualify if:

• Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
• Known hypersensitivity to the study drug duvelisib or excipients.
• Previous treatment with a PI3K inhibitor or BTK inhibitor.
• Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
• Prior chemotherapy, cancer immunosuppressive therapy, radiotherapy or other investigational agents within 4 weeks before the first dose of study drug.
• Symptomatic central nervous system (CNS) Lymphoma.
• Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
• Human immunodeficiency virus (HIV) infection.
• Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection.
• Hepatitis B or hepatitis C Infection.
• 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.
• Female subjects who are pregnant or breastfeeding.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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: April 24, 2020
• First Posted: January 13, 2021
• Study Start: December 18, 2019
• Primary Completion: October 31, 2021
• Study Completion: March 31, 2022
• Last Updated: January 13, 2021

Record last verified: 2020-01

Locations

CN (1)