Health TrialsbyHealthPanel

Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL

ConditionDLBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRuijin Hospital

About this trial

This trial is a prospective, single-center, randomized controlled clinical research. The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;

18≤ age ≤65 years old, male or female;

ECOG score 0-2;

White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;

Disqualifiers

Previously received autologous hematopoietic stem cell transplantation;

Suffering from serious complications or severe infection;

Previous treatment with selinexor;

Central nervous system lymphoma was excluded;

Trial design

Design model

Parallel

Treatments tested in this trial

  • zanubrutinib combined with BEAM

    Drug

    zanubrutinib：160mg oral bid D-8-D-2 camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2

  • BEAM

    Drug

    camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: zanubrutinib combined with BEAMExperimental treatment 1 intervention
Group B: BEAMActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

Progression-free survival was defined as the time from the data of ASCT until the date of the first documented day of disease progression or relapse, using Lugano criteria, or death from an cause, whichever occured first.

Time frame
Baseline up to data cut-off (up to approxiamately 2 years)

Secondary outcomes

1

Overall survival

Overall survival was defined as the time from the date of ASCT to the date of death from any cause

Time frame
Baseline up to data cut-off (up to approxiamately 2 years)
2

Complete remission rate

Percentage of participants with complete response was determined on 2014 Lugano criteria

Time frame
3 months after the transplantation
3

The time of hematopoietic reconstruction

The first day of neutrophils ≥0.5\*109/L for 3 consecutive days was the time of successful implantation of granulocytes. Platelet ≥20.0\*109/L for 7 consecutive days and the first day after platelet infusion was considered as the successful time of megakaryocytes implantation

Time frame
2 months after the transplantation
4

Transplantation-related adverse reactions

Transplantation-related adverse reactions are any untoward medical occurrence in a participant which is related to ASCT.

Time frame
Baseline up to data cut-off (up to approxiamately 4 years)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

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