Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations Clinical Trial
Official title:
Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations
| NCT number | NCT02674750 |
| Other study ID # | CUDC-907-201 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | July 2016 |
| Est. completion date | May 28, 2019 |
| Verified date | April 2022 |
| Source | Curis, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 70 |
| Est. completion date | May 28, 2019 |
| Est. primary completion date | May 28, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital Durán i Reynals, Servicio de Oncología | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitario Puerta de Hierro | Madrid | |
| Spain | Hospital Universitario de Salamanca | Salamanca | |
| United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | University of Chicago | Chicago | Illinois |
| United States | Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | University of California San Francisco-Fresno | Fresno | California |
| United States | Penn State Hershey Cancer Institute-Clinical Trials Office | Hershey | Pennsylvania |
| United States | Houston Methodist Hospital | Houston | Texas |
| United States | The University of Texas M.D. Anderson Cancer Center | Houston | Texas |
| United States | University of Tennessee Cancer Center | Knoxville | Tennessee |
| United States | University of Southern California, Norris Comprehensive Cancer Center | Los Angeles | California |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | Tennessee Oncology Sarah Cannon | Nashville | Tennessee |
| United States | University of Oklahoma Health Sciences Center (OUHSC) | Oklahoma City | Oklahoma |
| United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester | Rochester | New York |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Moffitt Cancer Center | Tampa | Florida |
| United States | Cancer Care Associates | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Curis, Inc. |
United States, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL) | 2 Years | |
| Secondary | Median Progression-free Survival | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL | 1 year | |
| Secondary | Overall Survival (OS) | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL | 1 year | |
| Secondary | Disease Control Rate (DCR) | Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL Note: Response is defined using Cheson 2007 criteria. CR=Complete Response; PR=Partial Response; SD=Stable Disease. a. Two-sided exact binomial 95% confidence interval. Revised Response Criteria for Malignant Lymphoma (Cheson 2007) was used for the assessment of response. DCR is defined as the proportion of patients having best response of complete response, partial response, or stable disease. | 1 year | |
| Secondary | Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters | Number of participants and severity of adverse events (AEs), serious adverse events (SAEs), and other safety parameters in patients receiving CUDC-907. | AEs were collected for each participant for the duration that they remained on the study, on average of 4 months |