Follicular LymphomaNCT05923502
(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
An observational study of Follicular Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Ruijin Hospital.
Trial summary
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Richter Syndrome
- What is being tested?
- Duvelisib
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Population who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).
Who may be able to join
- To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits;
- Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF));
- Pathologically or Histologically confirmed NHL including but not limited to the following subtypes:
- Follicular lymphoma (FL);
- Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS);
- Marginal zone lymphoma (MZL);
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- Peripheral T-cell lymphoma (PTCL);
- Diffuse large B-cell lymphoma (DLBCL).
- Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment;
- Must have adequate organ function defined by the following laboratory parameters:
- Bone marrow function: Absolute neutrophil count (ANC) ≥ 0.5 × 10^9/L, Platelet count (PLT) ≥ 25 × 10^9/L, blood transfusion can be used before medication;
- Liver and kidney function: Aspartate transaminase (AST) and alanine aminotransferase (ALT)≤5.0 × ULN;
- Estimated creatinine clearance value ≥30 milliliters/minute (as determined by the Cockcroft-Gault method).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Patients with infections should be treated first and then considered for enrollment when the infection is under control.
Who cannot join
- Female subjects who are pregnant or breastfeeding;
- Estimated lifetime is less than 3 months;
- In the investigator's judgment, patients who require but are unable to receive prophylactic treatment for Pneumocystis or herpes simplex virus (HSV) prior to trial drug treatment;
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function;
- Prior history of drug-induced colitis or drug-induced interstitial pneumonia;
- Known hypersensitivity to Duvelisib or its excipients;
- Administration of medications or foods that are strong inhibitors or inducers of CYP3A beginning 2 weeks prior to the first dose of Duvelisib;
- According to the judgement of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: (CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma.
Read the detailed description
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib administered to subjects who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).
- Conditions
- Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Richter Syndrome, Marginal Zone Lymphoma, Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Being tested
- Duvelisib
- Keywords
- NHL; Duvelisib
- Medical subject headings
- Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Peripheral, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuvelisibDrug
Also called Copiktra
This is a real-word. The treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients.
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients. | All patient who signed the consent form for participation to the study. Receives: Drug: Duvelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AE)
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.
Measured: From the first day of medication to 30 days after the last dose]
Secondary outcomes (5)
Overall Response Rate (ORR)
Defined as the best response of complete response/remission (CR) or partial response/remission (PR).
Measured: up to 6 cycles of therapy (each cycle is 28 days)]
Duration of remission (DOR)
Time from reaching CR or PR for the first time to disease progression.
Measured: 4 year
Progression-Free-Survival (PFS)
From date of inclusion to date of progression, relapse, or death from any cause.
Measured: 4 year
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Measured: 4 year
Quality of life (QOL)
The quality of life scale, ranging from 0 to 100. A score of 0 represents the worst health and a score of 100 represents the best health.
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start20 Oct 2023 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923502
- Sponsor's protocol ID
- CSPC-PI3K-NHL-K01
- Status last verified
- Oct 2023
- First submitted
- 20 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (CHANT)A Prospective, Multicenter, Non-interventionistic Real-world Study of Duvelisib Capsules in the Treatment of Non-Hodgkin's Lymphoma (NHL).
- ClinicalTrials.gov ID
- NCT05923502
- Acronym / sponsor ID
- CSPC-PI3K-NHL-K01
- Conditions
- Follicular Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Richter Syndrome, Marginal Zone Lymphoma, Peripheral T Cell Lymphoma, Diffuse Large B Cell Lymphoma
- Keywords
- NHL; Duvelisib
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma.
Detailed description
This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib administered to subjects who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients. | – | Drug: DuvelisibAll patient who signed the consent form for participation to the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).
Key inclusion criteria (15 listed)
- To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits;
- Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF));
- Pathologically or Histologically confirmed NHL including but not limited to the following subtypes:
- Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment;
- Must have adequate organ function defined by the following laboratory parameters:
Key exclusion criteria (8 listed)
- Female subjects who are pregnant or breastfeeding;
- Estimated lifetime is less than 3 months;
- In the investigator's judgment, patients who require but are unable to receive prophylactic treatment for Pneumocystis or herpes simplex virus (HSV) prior to trial drug treatment;
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function;
- Prior history of drug-induced colitis or drug-induced interstitial pneumonia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuvelisibAlso: CopiktraThis is a real-word. The treatment options are individualized according to the diagnosis and treatment experience of doctors in each center, diagnosis and treatment specifications and individual conditions of patients. | Drug | All enrolled patients. |
Primary outcome
Adverse events (AE)
Time frame: From the first day of medication to 30 days after the last dose]
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: up to 6 cycles of therapy (each cycle is 28 days)]
Duration of remission (DOR)
Time frame: 4 year
Progression-Free-Survival (PFS)
Time frame: 4 year
Overall survival (OS)
Time frame: 4 year
Quality of life (QOL)
Time frame: 4 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weili Zhao, PhD principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Ruijin Hospital.
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 15 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, PhD (021-64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AE) (time frame: From the first day of medication to 30 days after the last dose]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.