Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc AlterationsPhase 2NCT02674750

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

A Phase 2 study testing CUDC-907 in people with Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations, run by Curis, Inc. at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations
What is being tested?: CUDC-907
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 25 sitesin 2 countries
Study dates: Jul 2016to 28 May 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States20 sites

Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Chicago
Chicago, Illinois, 60647
Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of California San Francisco-Fresno
Fresno, California, 93701
Penn State Hershey Cancer Institute-Clinical Trials Office
Hershey, Pennsylvania, 17033
Houston Methodist Hospital
Houston, Texas, 77030
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
University of Tennessee Cancer Center
Knoxville, Tennessee, 37920
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Norton Cancer Institute
Louisville, Kentucky, 40207
Tennessee Oncology Sarah Cannon
Nashville, Tennessee, 37203
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, Oklahoma, 73104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 55905
Swedish Cancer Institute
Seattle, Washington, 98104
Moffitt Cancer Center
Tampa, Florida, 33612
Cancer Care Associates
Tulsa, Oklahoma, 74104

Other trials in United States

Spain5 sites

Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Hospital Durán i Reynals, Servicio de Oncología
Barcelona, 08908
Hospital Universitario Puerta de Hierro
Madrid, 28220
Hospital Universitario de Salamanca
Salamanca, 37007

Other trials in Spain

About this study

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

Read the 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.

Conditions: Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations
Being tested: CUDC-907
Keywords: DLBCL, MYC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CUDC-907Drug

Study groups in NCT02674750
Study group	Role	What they receive
Group A	Experimental	Group A: MYC translocation+ and/or MYC gene copy number gain by FISH Receives: Drug: CUDC-907
Group B	Experimental	Group B: MYC expression in > 40% of tumor cells by IHC Receives: Drug: CUDC-907
Group C	Experimental	Group C: MYC translocation- by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH Receives: Drug: CUDC-907

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR)
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered Diffuse Large B-Cell Lymphoma (DLBCL)
Measured: 2 Years

Secondary outcomes (4)

Median Progression-free Survival
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL
Measured: 1 year
Overall Survival (OS)
Efficacy of CUDC-907 in subjects with Relapsed/Refractory MYC-altered DLBCL
Measured: 1 year
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.
Measured: 1 year
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.
Measured: AEs were collected for each participant for the duration that they remained on the study, on average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201628 May 2019

First posted4 Feb 2016 (estimated)
Study startJul 2016
Primary completion28 May 2019
Study completion28 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc AlterationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02674750
Sponsor's protocol ID: CUDC-907-201
Status last verified: Apr 2022
First submitted: 29 Jan 2016
Last updated: 27 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02674750
Acronym / sponsor ID: CUDC-907-201
Conditions: Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations
Keywords: DLBCL, MYC
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Curis, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2016
Primary completion: 28 May 2019 (actual)
Study completion: 28 May 2019 (actual)
First posted: 4 Feb 2016 (estimated)
Results: Posted 27 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Drug: CUDC-907Group A: MYC translocation+ and/or MYC gene copy number gain by FISH
Group B	Experimental	Drug: CUDC-907Group B: MYC expression in > 40% of tumor cells by IHC
Group C	Experimental	Drug: CUDC-907Group C: MYC translocation- by FISH, and MYC expression in < 40% of tumor cells, and no MYC gene copy number gain by FISH

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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:

Key exclusion criteria (9 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CUDC-907	Drug	Group A, Group B, Group C

Primary outcome

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)

4 secondary outcomes

Median Progression-free Survival
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
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

Results and safety

Results posted to the registry on 27 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	5	0
Group B	49	4
Group C	16	4

Primary outcome: Objective Response Rate (ORR)

Time frame: 2 Years

Population analysed: The analysis of ORR was not performed since central radiographic review was not performed, due to inconclusive efficacy at the interim analysis, enrollment was permanently stopped in August 2017.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected for each participant for the duration that they remained on the study, on average of 4 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CUDC-907	30 of 68 (44.1%)	68 of 68 (100%)	17 of 68

Limitations and caveats (from the sponsor): Due to inconclusive efficacy at the interim analysis, enrollment was permanently stopped in August 2017.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

25 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CUDC-907 in people with Relapsed and/or Refractory Diffuse Large B-cell Lymphoma Including With Myc Alterations, run by Curis, Inc. at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.