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BV in the Treatment of Relapsed/refractory Hodgkin Lymphoma

ConditionHodgkin Lymphoma (Category)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorXiuhua Sun

About this trial

The goal of this clinical trial is to explore the real-world Chinese relapsed/refractory patients to evaluate the efficacy and safety of BV monotherapy or combination therapy in CHL patients. The main questions it aims to answer are:

To evaluate the efficacy and toxicity of BV-containing regimen in relapsed/refractory CHL patients in China, and to provide reference for the rational and safe use of BV in clinical practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically, classical hodgkin lymphoma（cHL） was diagnosed and relapsed or refractory.

Patients were treated with BV-containing regimen at least once

Presence of tumor (measurable or nonmeasurable).

Signature of the form consent for participation in the study.

Disqualifiers

<18 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brentuximab Vedotin (Bv)

    Drug

    1.2mg/kg/2w or 1.8mg/kg/3w

  • Sintilimab

    Drug

    200mg/3w

  • Tislelizumab

    Drug

    200mg/3w

  • Bendamustine

    Drug

    90mg/m2/3w

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: BV monotherapy groupActive comparator 1 intervention
Group B: BV combined treatment groupActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Preliminary Overall Response Rate (ORR)

Will be calculated and a 95% confidence interval will be estimated using the Clopper-Pearson method. Assessed per Lugano 2014 Criteria at any time point while on study therapy.

Time frame
Up to 16 cycles (each cycle is 21 days)
2

Progression-free survival (PFS)

Will be described using the Kaplan-Meier methodology. 95% confidence intervals for 1-year PFS will be calculated, with standard errors estimated using the Greenwood formula. Patients alive without disease progression will be censored at last follow-up date.

Time frame
From time of study enrollment until first documentation of progressive disease or death from any cause, assessed up to 3 years

Secondary outcomes

1

Safety and tolerability of Brentuximab Vedotin

Adverse reactions after application of BV-containing regimen, especially hematologic toxicity

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Xiuhua Sun

Lead sponsor

Dalian Medical University

Sponsor institution

Source ClinicalTrials.gov

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