An interventional study of Venetoclax and Carmustine in Diffuse Large B Cell Lymphoma, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-18.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
This single-center, randomized clinical study will evaluate the efficacy and safety of Venetoclax combined with BEAM Pretreatment Regimen in ASCT treatment of DLBCL patients.
Diffuse Large B-cell lymphoma (DLBCL) is a group of highly heterogeneous aggressive non-Hodgkin lymphomas with different pathogenesis and clinical prognosis. Despite the survival benefits of Anthracycline-based chemotherapy bridging autologous stem cell transplantation (ASCT), 30%-40% of DLBCL patients fail to respond to treatment and relapse or die within a short period of time. A phase I/II trial of Venetoclax combined with BEAM as a pretreatment regimen for ASCT of high-risk and relapsed/refractory lymphoma was presented at the ASH Meeting 2021 (NCT03583424), and it studies the side effects and best dose of venetoclax when given together with BEAM (carmustine, etoposide, cytarabine, and melphalan) before stem cell transplant in treating participants with relapsed or refractorynon-Hodgkin lymphoma. The results confirmed that Venetoclax has a good prospect in ASCT.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 52 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :
Exclusion Criteria:
Laboratory test value during screening;
Patients in this arm will receive Venetoclax Combined With BEAM (Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT. Participants receive Venetoclax PO QD on days -10 to -1, Carmustine IV on day -7, Etoposide IV BID on days -6 to -3, Cytarabine IV BID on days -6 to -3, and Melphalan IV on day -2. Participants then undergo hematopoietic cell transplantation on day 0.
Drug: Venetoclax · Drug: Carmustine · Drug: Cytarabine · Drug: Etoposide · Drug: Melphalan · Procedure: Hematopoietic Cell Transplantation
Patients in this arm will receive BEAM (Carmustine, Etoposide Cytarabine and Melphalan) as Pretreatment Regimen of ASCT. Participants receive Venetoclax PO QD on days -10 to -1, Carmustine IV on day -7, Etoposide IV BID on days -6 to -3, Cytarabine IV BID on days -6 to -3, and Melphalan IV on day -2. Participants then undergo hematopoietic cell transplantation on day 0.
Drug: Carmustine · Drug: Cytarabine · Drug: Etoposide · Drug: Melphalan · Procedure: Hematopoietic Cell Transplantation
100mg day -10, 200mg day -9, 400mg day -8, 800mg day -7 to -1, Given PO
300mg/m2 day -7, Given IV
100mg/m2/d, day -6 to day -3, Given IV
200mg/m2/d, day -6 to day -3, Given IV
140mg/m2, day -2, Given IV
Undergo hematopoietic cell transplantation
Progression free survival
Progression-free survival was defined as the time from the date of ASCT until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from an cause, whichever occurred first.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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 approximately 2 years)
Complete remission rate
Percentage of participants with complete response was determined on 2014 Lugano criteria.
Time frame: Baseline up to data cut-off (up to approximately 2 years)
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: Baseline up to data cut-off (up to approximately 2 years)
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 approximately 2 years)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Ruijin Hospital