NCT06285825 A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia
| NCT ID | NCT06285825 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Cytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-07-05 |
| Primary Completion | 2026-08-22 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: Eligible participants will be considered for inclusion in this study if they meet the following criteria based on tests obtained less than 4 weeks from first dose: 1. Relapsed or refractory FL (grade 1, 2, 3a and 3b), MCL, DLBCL, PMBCL, tFL, or HGBCL 2. Received standard of care therapy with axi-cel, tisa-cel or liso-cel 3. Age ≥ 18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 5. Either in remission after CART and/or with refractory/progressive disease not requiring urgent treatment in the opinion of the treating physician 6. Grade 3-4 cytopenia defined as either absolute neutrophil count of \< 1.0x109/L, or platelet count \< 50x109/L or haemoglobin\< 8 g/dL starting or persisting between day 30 and day 90 after CART 7. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min 8. Serum alanine transaminase (ALT) / aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN), independently from etiology 9. Total biliru