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

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ClinicalTrials.gov Identifier: NCT02674750
Recruitment Status : Completed
First Posted : February 4, 2016
Results First Posted : April 27, 2022
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Curis, Inc.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations Drug: CUDC-907 Phase 2

Detailed Description:

Patients with RR DLBCL will be eligible for treatment with CUDC-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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2016
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Group A: MYC translocation+ and/or MYC gene copy number gain by FISH
 Drug: CUDC-907
Experimental: Group B
Group B: MYC expression in > 40% of tumor cells by IHC
 Drug: CUDC-907
Experimental: 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
 Drug: CUDC-907


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 2 Years ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)


Secondary Outcome Measures :
  1. Median Progression-free Survival [ Time Frame: 1 year ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL

  2. Overall Survival (OS) [ Time Frame: 1 year ]
    Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL

  3. Disease Control Rate (DCR) [ Time Frame: 1 year ]
    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.

  4. Number of Participants and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Parameters [ Time Frame: AEs were collected for each participant for the duration that they remained on the study, on average of 4 months ]
    Number of participants and severity of adverse events (AEs), serious adverse events (SAEs), and other safety parameters in patients receiving CUDC-907.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674750


Locations
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Sponsors and Collaborators
Curis, Inc.
  Study Documents (Full-Text)

Documents provided by Curis, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] August 30, 2016
Informed Consent Form  [PDF] February 2, 2017

More Information
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Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT02674750    
Other Study ID Numbers: CUDC-907-201
First Posted: February 4, 2016    Key Record Dates
Results First Posted: April 27, 2022
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Curis, Inc.:
DLBCL
MYC
Additional relevant MeSH terms:
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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