Lymphoma, Large B-Cell, Diffuse (DLBCL) Clinical Trial
Official title:
Single-Arm, Open-Label Study To Evaluate The Safety, Tolerability And Preliminary Efficacy Of NM-IL-12 (rHuIL‐12) In Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Undergoing Salvage Chemotherapy
NM-IL-12 is being evaluated as an immunotherapeutic with concomitant hematopoietic regenerating properties for treatment of relapsed/refractory DLBCL, an aggressive type of B-cell non-Hodgkin's lymphoma (NHL). Determination of the maximum tolerated dose (MTD) for NM-IL-12 is not planned in this study, rather, a pre-defined dose of 150 ng/kg will be explored; this dose is based on two safety and tolerability studies of NM-IL-12 in healthy volunteers.
This is a single-arm, open-label, non-randomized, multi-center study with NM-IL-12 dosed in
combination with salvage chemotherapy regimens (R-ICE = rituximab plus
ifosfamide-carboplatin-etoposide, R-DHAP = rituximab plus cytosine
arabinoside-cisplatin-dexamethasone) for treatment of patients with relapsed/refractory
DLBCL.
NM-IL-12 (150 ng/kg) will be administered subcutaneously. Patients will be monitored as
routinely practiced; in addition, approximately 1 day after NM-IL-12 injection, patients
will have a home visit by a nurse for blood sampling related to pharmacokinetic and
pharmacodynamic (PK/PD) evaluation.
Twelve patients are planned to be enrolled into the study; initially 6 patients will be
enrolled. The decision to continue and recruit the remaining six patients will be made by
Data Safety Monitoring Board (DSMB) after review of relevant safety data, clinical
laboratory evaluations, and vital signs collected up to 21 days post enrollment of the last
patient in the first treated group. Common Terminology Grades for Adverse Events (CTCAE)
guidelines will be used to determine dose-modifying criteria (DMC).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05406401 -
A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)
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Phase 2 |