Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations
Condition: Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: CUDC-907
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DLBCL; MYC

Summary:

      This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety
      of CUDC-907 in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse
      Large B-Cell Lymphoma (DLBCL).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 18 years.

          2. At least 2 but no more than 4 prior lines of therapy for the treatment of de novo
             DLBCL and ineligible for (or failed) autologous or allogeneic stem cell transplant
             (SCT) (salvage therapy, conditioning therapy and maintenance with transplant will be
             considered one prior treatment). NOTE: For follicular lymphoma transformed to DLBCL
             (t-FL/DLBCL), single agent non-cytotoxic therapy will not be considered as a line of
             therapy.

          3. Histopathologically confirmed diagnosis of one of the following:

               -  RR DLBCL per the 2008 World Health Organization (WHO) classification of
                  hematopoietic and lymphoid tumors (Swerdlow et al, 2008).

               -  High grade B-cell lymphoma (HGBL), with MYC and BCL2 and/or BCL6 rearrangements
                  or DLBCL, NOS per the 2016 revision of the WHO classification of lymphoid
                  neoplasms (Swerdlow et al, 2016).

               -  Diagnosis of t-FL/DLBCL is allowed. However, other B-cell lymphomas including
                  other transformed indolent lymphomas/DLBCL per the 2008 WHO classification, and
                  Burkitt lymphoma are not eligible.

        Exclusion Criteria:

          1. Known primary mediastinal, ocular, epidural, testicular or breast DLBCL.

          2. Active CNS involvement of their malignancy.

          3. Known allergy or hypersensitivity to phosphatidylinositol 3 kinase (PI3K) inhibitors
             or any component of the formulations used in this study.

          4. Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine
             analogues) or any other systemic anticancer therapy within 2 weeks of study entry.

          5. Radiotherapy delivered to non-target lesions within one week prior to starting study
             treatment or delivered to target lesions that will be followed on the study (note:
             prior sites of radiation will be recorded).

          6. Treatment with experimental therapy within 5 terminal half-lives (t1/2) or 4 weeks
             prior to enrollment, whichever is longer.

          7. Current or planned glucocorticoid therapy, with the following exceptions:

               -  Doses ≤ 10 mg/kg/day prednisolone or equivalent is allowed, provided that the
                  steroid dose has been stable or tapering for at least 14 days prior to the first
                  dose of CUDC-907.

               -  Inhaled, intranasal, intraarticular, and topical steroids are permitted.