A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia
ConditionCytopenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Relapsed or refractory FL (grade 1, 2, 3a and 3b), MCL, DLBCL, PMBCL, tFL, or HGBCL
Received standard of care therapy with axi-cel, tisa-cel or liso-cel
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Disqualifiers
History of malignancy other than nonmelanoma skin cancer or localized carcinoma (e.g., cervix, bladder, breast, prostate) unless disease free for at least 3 years.
History of Richter's transformation of chronic lymphocytic leukemia (CLL)
Presence of grade 3-4 cytopenia before initiation of lymphodepleting chemotherapy for CART
Grade 3-4 cytopenia due to use of experimental non-commercially available CART product
Trial design
Design model
Single group
Treatments tested in this trial
Emapalumab
DrugGiven by Infusion
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: EmapalumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Sobi, Inc.
Collaborator
Source ClinicalTrials.gov