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

Primary Purpose

Follicular Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Duvelisib

About this trial

This is an interventional treatment trial for Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Shanghai Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duvelisib

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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

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

Duration of Response;

Progression-free survival;

Overall survival;

Time to response;

Maximum Plasma Concentration (ng/ml) for duvelisib and its metabolite IPI-656;

Area under the Curve (ng*h/ml) for duvelisib and its metabolite IPI-656;

Elimination half life (h) for duvelisib and its metabolite IPI-656;

Full Information

NCT ID

NCT04707079

First Posted

April 24, 2020

Last Updated

January 10, 2021

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04707079

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 18, 2019 (Actual)

Primary Completion Date

October 31, 2021 (Anticipated)

Study Completion Date

March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Follicular Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Duvelisib

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Duvelisib

Other Intervention Name(s)

COPIKTRA

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR),

Description

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)

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.

Secondary Outcome Measure Information:

Title

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

Time Frame

Title

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

Time Frame

Title

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.

Title

Duration of Response;

Time Frame

Title

Progression-free survival;

Time Frame

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

Title

Overall survival;

Time Frame

Every 3 months; for an average survival follow-up of 3 years.

Title

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.

Title

Maximum Plasma Concentration (ng/ml) for duvelisib and its metabolite IPI-656;

Time Frame

Every 4 weeks for 12 weeks.

Title

Area under the Curve (ng*h/ml) for duvelisib and its metabolite IPI-656;

Time Frame

Every 4 weeks for 12 weeks

Title

Elimination half life (h) for duvelisib and its metabolite IPI-656;

Time Frame

Every 4 weeks for 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

Shanghai Ruijin Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weili Zhao, PhD

Phone

021-64370045

zwl_trial@163.com

First Name & Middle Initial & Last Name & Degree

Weili Zhao, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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