Pirtobrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL
ConditionDLBCL
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRuijin Hospital
About this trial
This trial is a prospective, multi-center, single-arm clinical research. The intention is to evaluate the efficacy and safety of pirtobrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ≤70 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;
Central nervous system lymphoma was excluded;
A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
Trial design
Design model
Single group
Treatments tested in this trial
pirtobrutinib combined with BEAM
Drugpirtobrutinib 200mg oral qd 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: 70mg/m2 vgtt qd D3-D-2.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: pirtobrutinib combined with camustine, etoposide, cytarabine, and mafaran (BEAM)Experimental treatment 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 transplantation3
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 transplantation4
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)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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