Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)
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|ClinicalTrials.gov Identifier: NCT02169505|
Recruitment Status : Terminated (Slow Accrual)
First Posted : June 23, 2014
Results First Posted : May 17, 2019
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Brentuximab Vedotin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Brentuximab Vedotin Maintenance After Allogeneic and Haploidentical Stem Cell Transplantation in High Risk CD30+ Lymphoma (Hodgkin Lymphoma and ALCL)|
|Actual Study Start Date :||May 22, 2015|
|Actual Primary Completion Date :||August 14, 2017|
|Actual Study Completion Date :||August 14, 2017|
Experimental: Brentuximab Vedotin
Brentuximab by vein over 30 minutes every 3 weeks for a total of 6 cycles starting between days 30 and 60 post allogeneic stem cell transplant (SCT).
Brentuximab dose based on actual body weight starting with an initial dose of 1.2 mg/kg for the first 2 cycles and dose increased to 1.8 mg/kg after the second cycle for all subsequent cycles.
Drug: Brentuximab Vedotin
Starting dose: 1.2 mg/kg by vein on Day 1 for the first 2, 21 day cycles. Dose increased to 1.8 mg/kg by vein after the second cycle for all subsequent cycles.
- Number of Participants With Secondary Graft Failure [ Time Frame: An average of 12 months ]Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of <10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.
- Number of Participants With Hematologic Toxicity [ Time Frame: an average of 12 months ]The most common grade > 3 side effects on Brentuximab.
- Number of Participants With Relapse [ Time Frame: an average of 12 months ]Evaluate the safety of brentuximab early after allogeneic stem cell transplant and haploidentical allogeneic transplantant and observe if there is a decrease in the risk of relapse.
- Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease. [ Time Frame: an average of 12 months ]Evaluate the CMV in blood
- Number of Participants With Acute Graft-versus-host Disease (GVHD). [ Time Frame: an average of 12 months ]The tissue and serum in participants were measured by the GVHD
- Number of Participants With Central and Effector Cell Effects [ Time Frame: an average of 12 months ]We will perform on peripheral blood for mononuclear cells (PBMC) and serum collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as other immune subsets.
- Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration [ Time Frame: an average of 12 months ]Immunological correlative studies on peripheral blood mononuclear cells (PBMC) and serum will be collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as CD30 levels.
- Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance [ Time Frame: an average of 12 months ]The Kaplan-Meier (1958) survival curves were used to estimate the overall survival and progression-free survival. Cox proportional hazards regression analysis was used to model the association between overall survival and progression-free survival and disease and demographic covariates of interest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169505
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sairah Ahmed, MD||M.D. Anderson Cancer Center|