Study to Evaluate the Efficacy and Safety of CUDC-907 in Patients With RR DLBCL, Including Patients With MYC Alterations
NCT ID: NCT02674750
Last Updated: 2022-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2016-07-31
2019-05-28
Brief Summary
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Detailed Description
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* Fresh tumor tissue obtained from biopsy accessible lesions , or
* Archived tumor tissue (most recent available)
Subjects will be required to submit archival tumor samples (most recent available) or fresh tumor samples for central FISH and IHC testing. Subjects whose tumors have been previously characterized as MYC-altered are strongly encouraged to enter the study. For subjects who enter the study with unconfirmed MYC-altered disease, fresh tumor samples are preferred.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Group A: MYC translocation+ and/or MYC gene copy number gain by FISH
CUDC-907
Group B
Group B: MYC expression in \> 40% of tumor cells by IHC
CUDC-907
Group C
Group C: MYC translocation- by FISH, and MYC expression in \< 40% of tumor cells, and no MYC gene copy number gain by FISH
CUDC-907
Interventions
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CUDC-907
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Curis, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CUDC-907-201
Identifier Type: -
Identifier Source: org_study_id
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