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Study to Evaluate the Efficacy and Safety of CUDC-907 With and Without Rituximab in Patients With RR DLBCL, Including Patients With MYC Alterations

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Curis, Inc.
Sponsor:
Information provided by (Responsible Party):
Curis, Inc.
ClinicalTrials.gov Identifier:
NCT02674750
First received: January 29, 2016
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
This is a Phase 2, open-label, multicenter trial designed to evaluate the efficacy and safety of CUDC-907 monotherapy and R-907 (rituximab in combination with CUDC-907) in subjects 18 years and older with Relapsed/Refractory (RR) MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL).

Condition Intervention Phase
Relapsed and/or Refractory Diffuse Large B-cell Lymphoma
Drug: CUDC-907
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 With and Without Rituximab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma, Including Patients With MYC Alterations

Resource links provided by NLM:


Further study details as provided by Curis, Inc.:

Primary Outcome Measures:
  • The efficacy of CUDC-907 in terms of objective response rate (ORR) [ Time Frame: 2 Years ]
    Efficacy of CUDC-907 either alone or in combination with rituximab in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)


Secondary Outcome Measures:
  • The efficacy of CUDC-907 in terms of progression-free survival (PFS) [ Time Frame: 2 Years ]
    Efficacy of CUDC-907 either alone or in combination with rituximab in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate in terms of progression-free survival at 6 months (PFS6) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 either alone or in combination with rituximab in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate overall survival (OS) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 either alone or in combination with rituximab in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate the disease control rate (DCR) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 either alone or in combination with rituximab in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate the duration of response (DOR) [ Time Frame: 2 years ]
    Efficacy of CUDC-907 either alone or in combination with rituximab in subjects with Relapsed/Refractory MYC-altered DLBCL

  • To evaluate the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and other safety parameters in subjects receiving CUDC-907 and R-907 [ Time Frame: 2 years ]
    Safety of CUDC-907 either alone or in combination with rituximab in subjects with Relapsed/Refractory MYC-altered DLBCL


Estimated Enrollment: 200
Study Start Date: January 2016
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CUDC-907
RR-DLBCL, including with MYC alterations detected by FISH or by >=40% MYC by IHC
Drug: CUDC-907
Experimental: CUDC-907 + Rituximab
RR-DLBCL, including with MYC alterations detected by FISH or by >=40% MYC by IHC
Drug: CUDC-907 Drug: Rituximab

Detailed Description:

Patients with RR DLBCL will be eligible for treatment with CUDC-907 or R-907, as long as they have tumor tissue available that can be tested for MYC-altered disease based on one of the following:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 RR DLBCL (2008 WHO classification) or MYC-altered high grade B-cell lymphoma (HGBL) (2016 WHO classification).

    • Diagnosis oft-FL/DLBCL is allowed. Other B-cell lymphomas including B- cell lymphoma unclassifiable with features intermediate between DLBCL and Burkitt lymphoma and Burkitt lymphoma are not eligible.

  4. Confirmed availability of viable tissue (defined as most recent available archival tissue, or fresh tumor samples) for central laboratory FISH and IHC testing prior to study dosing. For subjects who enter the study with unconfirmed MYC-altered disease, fresh tumor samples are preferred.

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) within 2 weeks of study entry.
  5. Radiotherapy 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 > 1 mg/kg/day prednisolone or equivalent, except for replacement steroid dosing ( < 30 mg/day hydrocortisone or the equivalent) or treatment of infusion reactions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02674750

Contacts
Contact: David Tuck, MD clinicaltrials@curis.com

Locations
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
United States, Oklahoma
University of Oklahoma Health Sciences Center (OUHSC) Recruiting
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute, LLC Recruiting
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Curis, Inc.
  More Information

Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT02674750     History of Changes
Other Study ID Numbers: CUDC-907-201
Study First Received: January 29, 2016
Last Updated: July 28, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Curis, Inc.:
BCL2
BCL6
MYC-Altered
Double Hit (DH)
Double Expressor (DE)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on March 29, 2017