Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma (NCT04676360) | Clinical Trial Compass
TerminatedPhase 2
Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma
Stopped: The study was closed given lack of efficacy and plans to publish this negative study.
United States10 participantsStarted 2021-07-01
Plain-language summary
In this research study is looking to see how safe and effective belantamab mafodotin is in relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma.
* This research study involves the study drug belantamab mafodotin.
* Belantamab mafodotin is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a drug. It works by using the antibody portion to enter into the lymphoma cells, and then releasing the drug portion to kill the lymphoma cells.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have relapsed or refractory plasmablastic lymphoma or ALK+ large Bcell lymphoma by WHO criteria.
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter \[LDi\] to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥15 mm in LDi for nodal disease or ≥10 mm in LDi for extranodal lesions.
* Participants must have received prior systemic lymphoma therapy.
* Age ≥18 years. Because no dosing or adverse event data are currently available on the use of belantamab mafodotin in participants \<18 years of age, children are excluded from this study.
* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
* Participants must have adequate marrow function as defined below (unless abnormalities are considered related to marrow and/or splenic involvement by lymphoma):
* absolute neutrophil count ≥1,000/mcL
* platelets ≥50,000/mcL
* hemoglobin ≥ 8.0 g/dL
* Participants must have adequate organ function as defined below:
* total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN); (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
* AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
* Spot urine (albumin/creatinine) \<500 mg/g (56 mg/mmol) OR
* Urine Dipstick Negative/trace (if ≥1+ only eligible if confirmed ≤ 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot …