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Lymphoma, B-CellPhase 1NCT03458546

Study of Roflumilast in Combination With Standard Chemotherapy for High-risk Diffuse Large B-cell Lymphoma

A Phase 1 study testing Roflumilast in people with Lymphoma, B-Cell, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

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 study is a phase Ib, single arm, open label clinical trial that will enroll patients with untreated diffuse large B-cell lymphoma (DLCBL) at moderate or high risk for poor outcome Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
Roflumilast
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
21 May 2018to 16 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Men and women 18 years of age or older.
  • Pathologically proven diffuse large B-cell lymphoma.
  • No prior systemic therapy for lymphoma.
  • NCCN-IPI risk score of 2 or higher.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Life expectancy of ≥3 months.
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  • Ann Arbor stage II-IV
  • Measurable disease, meaning at least 1 lymph node or other lymphomatous lesion with a long axis of ≥1.5 cm by CT imaging, and at least one FDG-avid lesion by FDG-PET scan.
  • Left ventricular ejection fraction of at least 45% by either echocardiography or radionucleotide angiography.
  • Ability to swallow oral tablets without difficulty.
  • All subjects with preserved reproductive potential must agree to practice abstinence or employ contraceptive measures for the duration of treatment and for 4 weeks following final dosing. All male subjects are considered to have reproductive potential. Female subjects of reproductive potential are those who: 1) are not at least 50 years old and have no menses for 24 consecutive months; or 2) have not been rendered surgically sterile (having undergone hysterectomy and/or bilateral salpingo-oophorectomy). Female subjects of reproductive potential must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin ([hCG]) within 7 days of first day of drug dosing.
  • Meet the following clinical laboratory requirements: - Creatinine clearance ≥30 ml/min by Cockcroft-Gault formula ; - Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (unless indirect bilirubin is elevated due to Gilbert's syndrome or hemolysis); - AST and ALT≤ 3 × ULN; - Platelet count ≥ 50,000/μL, with or without transfusion support; - ANC ≥ 1000/μL, with or without chronic granulocyte growth factor support; - Hemoglobin ≥8 g/dL, with or without transfusion support.

Who cannot join

  • Allergy or intolerance to roflumilast.
  • Any active malignancy other than DLBCL
  • Prior allogeneic bone marrow transplant within 12 months of screening date.
  • Prior autologous stem cell transplant within 6 months of screening date.
  • Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing.
  • Active central nervous system (CNS) involvement by lymphoma, including untreated symptomatic epidural disease
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  • Active uncontrolled infection.
  • Clinically documented history of severe depression and/or suicidal thoughts or behavior.
  • Uncontrolled illness including but not limited to: symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV heart failure), unstable angina pectoris, uncontrolled cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements.
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stent placement within 6 months prior to study drug dosing.
  • History of another active cancer within 2 years prior to study drug dosing, excluding adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other adequately treated in situ carcinoma.
  • History of major surgery within 3 weeks or minor surgery within 1 week of roflumilast administration. Major surgery includes, for example, any open or laparoscopic entry into a body cavity, or operative repair of fracture; minor surgery includes, for example, open surgical biopsy of palpable/superficial lymph node, or placement of vascular access device.
  • Other medical or psychiatric illness or organ dysfunction, which in the opinion of the investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.
  • Corrected QT interval (QTc) prolongation (defined as a QTc >450 ms for males and >470 ms for females [Fridericia's correction]) or other clinically significant ECG abnormalities as assessed by the investigator.
  • Patients known to be HIV-positive must not have multi-drug resistant HIV infection, CD4 counts < 150/μl or other concurrent AIDS-defining conditions. Serologic screening for HIV is required within the 6 months prior to study enrollment.
  • Patients positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C-virus ribonucleic acid (HCV RNA), unless both AST and ALT≤1.25 x ULN and there is no known history of chronic active hepatitis. Serologic screening for hepatitis B and C testing is required within the 6 months prior to study enrollment.
  • Patients with moderate or severe liver impairment, as defined by a Child-Pugh class of B or C.
  • Women who are pregnant or breastfeeding.
  • Current use of any of the following medications: boceprevir, carbamazepine, ciprofloxacin, cobicistat, conivaptan, enzalutamide, fluvoxamine, itraconazole, ketoconazole, mitotane, phenytoin, posaconazole, rifampin, ritonavir, St. John's Wort, telaprevir, voriconazole, or zafirlukast.
  • Current use of non-nucleoside reverse transcriptase inhibitors (NNRTI) including efavirenz, rilpivirine, etravirine, delavirdine, nevirapine, and lersivirine.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mays Cancer Center, UT Health San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Phase Ib Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy for High-risk Diffuse Large B-cell Lymphoma

This study is a phase Ib, single arm, open label clinical trial that will enroll patients with untreated diffuse large B-cell lymphoma (DLCBL) at moderate or high risk for poor outcome

Read the detailed description

This study is a phase Ib, single arm, open label clinical trial that will enroll patients with untreated diffuse large B-cell lymphoma (DLCBL) at moderate or high risk for poor outcome, defined as an NCCN-IPI score of 2 or higher. Each patient's disease will be biologically characterized at baseline. Enrolled patients will receive chemoimmunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), administered every 21 days for 6 cycles, which is the standard of care. In addition, all patients will receive the study drug, roflumilast, at the standard dose of 500 μg by mouth once daily, throughout the 18-week treatment period.

Being tested
Roflumilast
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • RoflumilastDrug

    Also called Daliresp

    All patients will receive R-CHOP therapy at standard doses according to the standard preparation and infusion procedures of each investigational site, which is to be repeated every 21 days for a total of 6 cycles. All patients will receive a fixed oral dose of one 500 microgram (μg) tablet per day with or without food for all 21 days of each cycle, which will amount to a total of 126 doses of roflumilast.

Study groups in NCT03458546
Study groupRoleWhat they receive
Roflumilast and R-CHOPExperimentalNot described
Receives: Drug: Roflumilast

What is being measured

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

  1. To evaluate adverse drug reactions and toxicities as evaluated by NCI CTCAE using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03

    Measured: Measured every 3 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year

Timeline

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

  1. First posted8 Mar 2018
  2. Study start21 May 2018
  3. Primary completion31 Dec 2021
  4. Study completion16 Jan 2024

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03458546
Sponsor's protocol ID
CTMS# 17-0087
Other IDs
18-073H
Status last verified
Feb 2023
First submitted
19 Feb 2018
Last updated
21 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Duque AED, Ferrari PSSM, Ethiraj P, Jaafar C, Qiu Z, Holder K, Butler MJ, Huelgas-Morales G, Karnad A, Dahia PLM, Aguiar RCT. First-Line Combination of R-CHOP with the PDE4 Inhibitor Roflumilast for High-Risk DLBCL. Cancers (Basel). 2024 Nov 18;16(22):3857. doi: 10.3390/cancers16223857.

    PubMed 39594812

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Roflumilast in people with Lymphoma, B-Cell, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

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 12 inclusion and 20 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 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate adverse drug reactions and toxicities as evaluated by NCI CTCAE using the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 (time frame: Measured every 3 weeks for 21 day cycles for the duration of study treatment, estimated to be less than one year). 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 NCT03458546, which also lists 1 linked publication.

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 21 Feb 2024.

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