(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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));

Follicular lymphoma (FL);

Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS);

Disqualifiers

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;

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Duvelisib

    Drug

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: All enrolled patients.1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AE)

The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.

Time frame
From the first day of medication to 30 days after the last dose]

Secondary outcomes

1

Overall Response Rate (ORR)

Defined as the best response of complete response/remission (CR) or partial response/remission (PR).

Time frame
up to 6 cycles of therapy (each cycle is 28 days)]
2

Duration of remission (DOR)

Time from reaching CR or PR for the first time to disease progression.

Time frame
4 year
3

Progression-Free-Survival (PFS)

From date of inclusion to date of progression, relapse, or death from any cause.

Time frame
4 year
4

Overall survival (OS)

From the date of inclusion to date of death, irrespective of cause.

Time frame
4 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: