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

January 10, 2021 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

A Phase 2, Single Arm, Open Label, Multi-center Clinical Study of Dual PI3K-δ,γ Inhibitor Duvelisib in Patients With Relapsed/Refractory Follicular Lymphoma

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200020
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:
        • Principal Investigator:
          • Weili Zhao, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • COPIKTRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR),
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Time Frame
ORR assessed by study sites according to the Cheson 2007 Criteria;
Time Frame: 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.
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;
Time Frame: 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.
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;
Time Frame: Every 2-8 weeks; up to 30 days after the last dose of duvelisib.
Every 2-8 weeks; up to 30 days after the last dose of duvelisib.
Duration of Response;
Time Frame: 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.
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;
Time Frame: Every 12 weeks; for an average response / progression follow-up of 2 years.
Every 12 weeks; for an average response / progression follow-up of 2 years.
Overall survival;
Time Frame: Every 3 months; for an average survival follow-up of 3 years.
Every 3 months; for an average survival follow-up of 3 years.
Time to response;
Time Frame: From the date of the first dose until the date of first documented complete response or partial response, assessed up to 2 years.
From the date of the first dose until the date of first documented complete response or partial response, assessed up to 2 years.
Maximum Plasma Concentration (ng/ml) for duvelisib and its metabolite IPI-656;
Time Frame: Every 4 weeks for 12 weeks.
Every 4 weeks for 12 weeks.
Area under the Curve (ng*h/ml) for duvelisib and its metabolite IPI-656;
Time Frame: Every 4 weeks for 12 weeks
Every 4 weeks for 12 weeks
Elimination half life (h) for duvelisib and its metabolite IPI-656;
Time Frame: Every 4 weeks for 12 weeks
Every 4 weeks for 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2019

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

January 10, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 10, 2021

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE1801201901/PRO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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