A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma
Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial
≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Disqualifiers
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. prostate, cervix, bladder, breast) unless disease free for at least 12 months
History of Richter's transformation of chronic lymphocytic leukemia (CLL)
Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment
Trial design
Design model
Single group
Treatments tested in this trial
Loncastuximab Tesirine
DrugGiven by IV
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Loncastuximab TesirineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of conversion to complete response
Time frame
through study completion and or average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov