A Phase 2 interventional study of Ofatumumab in B-Cell Lymphomas, sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. Completed at 10 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-26.
Sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Phase 2, Interventional, and Treatment
The aim of this study is rate of acute graft-versus-host disease II-IV measured at day +365according to conventional criteria (Przepiorka et al. 1995) in patients with high risk non-Hodgkin lymphoma B subjects with Allogeneic Stem Cell Transplant
In addition to above:
Successful graft implantation: is defined as:
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 33 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
High risk CD +20 Lymphoma having at least one of the following characteristics:
Exclusion Criteria:
Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
Drug: Ofatumumab
Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
Also known as: ARZERRA
Rate of acute grade II-IV graft-versus-host disease at 1 year
According to conventional criteria. This endpoint will be descriptively reported. Confidence intervals (95% bounds) will be provided. The rate will be analyzed in all patients enrolled at the clinical trial and that no major violation has been produced.
Time frame: 5 years follow-up
To analyze the complete response rate after treatment. Further secondary outcomes as described in study summary
To analyze the complete response rate after treatment
Time frame: 5 years follow up
Plan to share: No
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea