Phase 1b/2 Trial of Pidnarulex in MYC Aberrant Lymphoma
National Cancer Institute (NCI)
Summary
This phase Ib/II trial tests the safety, side effects, best dose and how well giving CX-5461 works for the treatment of patients with B-cell non-Hodgkin lymphoma. CX-5461 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CX-5461 may be safe, tolerable and/or effective in treating patients with B-cell non-Hodgkin lymphoma.
Description
PRIMARY OBJECTIVES: I. To define dose limiting toxicity (DLT). (Phase 1) II. To assess toxicity profile. (Phase 1) III. To determine the recommended phase 2 dose (RP2D). (Phase 1) IV. To perform pharmacokinetic (PK) studies. (Phase 1) V. To examine the effect of CX-5461 (Pidnarulex) on gene expression profile of MYC aberrant lymphomas. (Phase 1) VI. To determine the objective response rate (ORR) (complete response \[CR\] and partial response \[PR\]). (Phase 2) SECONDARY OBJECTIVE: I. To observe and record anti-tumor activity. (Phase 1 and 2) EXPLORATORY OBJECTIVES: I. To determine the mec…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have one of the following subtypes of aggressive B-cell non-Hodgkin lymphomas: double-expressor lymphoma (DEL), high-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement, or Burkitt lymphoma (BL). Eligible patients must have received at least two prior lines of treatment for diffuse large B-cell lymphoma (DLBCL) or at least one prior line of therapy for Burkitt Lymphoma and must have disease for which no standard curative or palliative treatment options exist or remain effective (Quin et al., 2016) * Age ≥ 18 years. Because no dosing or…
Interventions
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo CSF and blood sample collection
- ProcedureComputed Tomography
Undergo PET/CT scan
- ProcedureLumbar Puncture
Undergo lumbar puncture
- DrugPidnarulex
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT scan
Locations (4)
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma
- University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, Pennsylvania