Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations

Completed · Phase 2

Conditions studied: Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations

In brief

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).

Key facts

Study ID

NCT02674750

Run by

Curis, Inc.

People needed

70

Starts

2016-07-01

Expected to finish

2019-05-28

Last updated by the study team

2022-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• 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.
• 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.

You may not qualify if…

• Known primary mediastinal, ocular, epidural, testicular or breast DLBCL.
• Active CNS involvement of their malignancy.
• Known allergy or hypersensitivity to phosphatidylinositol 3 kinase (PI3K) inhibitors or any component of the formulations used in this study.
• Cytotoxic anticancer therapy (e.g., alkylating agents, anti-metabolites, purine analogues) or any other systemic anticancer therapy within 2 weeks of study entry.
• 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).
• Treatment with experimental therapy within 5 terminal half-lives (t1/2) or 4 weeks prior to enrollment, whichever is longer.
• 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.

Where it is running

• University of California San Francisco-Fresno — Fresno, California, United States
• University of Southern California, Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Rochester — Rochester, New York, United States
• University of Oklahoma Health Sciences Center (OUHSC) — Oklahoma City, Oklahoma, United States
• Cancer Care Associates — Tulsa, Oklahoma, United States
• Penn State Hershey Cancer Institute-Clinical Trials Office — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Tennessee Cancer Center — Knoxville, Tennessee, United States
• Tennessee Oncology Sarah Cannon — Nashville, Tennessee, United States
• Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Durán i Reynals, Servicio de Oncología — Barcelona, Spain
• Hospital Universitario Puerta de Hierro — Madrid, Spain
• Hospital Universitario de Salamanca — Salamanca, Spain

Full record on ClinicalTrials.gov

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