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Follicular LymphomaPhase 2NCT04707079

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

A Phase 2 study testing Duvelisib in people with Follicular Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Duvelisib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
18 Dec 2019to 31 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai Municipality, 200020

    Weili Zhao, PhD, 021-64370045, zwl_trial@163.com

    Weili Zhao, PhD

    Recruiting

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Duvelisib
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DuvelisibDrug

    Also called COPIKTRA

    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.

Study groups in NCT04707079
Study groupRoleWhat they receive
DuvelisibExperimentalEligible 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.
Receives: Drug: Duvelisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

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

    Measured: 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.

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

    Measured: 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.

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

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

  4. Duration of Response;

    Measured: 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.

  5. Progression-free survival;

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

  6. Overall survival;

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

  7. Time to response;

    Measured: From the date of the first dose until the date of first documented complete response or partial response, assessed up to 2 years.

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

    Measured: Every 4 weeks for 12 weeks.

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

    Measured: Every 4 weeks for 12 weeks

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

    Measured: Every 4 weeks for 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start18 Dec 2019
  3. Primary completion31 Oct 2021 (estimated)
  4. Study completion31 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707079
Sponsor's protocol ID
HE1801201901/PRO
Status last verified
Jan 2020
First submitted
24 Apr 2020
Last updated
13 Jan 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Duvelisib in people with Follicular Lymphoma, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04707079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.

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