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Lymphoma, B-CellPhase 1NCT05796271

Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy

A Phase 1 study testing R-Chop and 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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is an investigator-initiated, phase II, single arm, open label clinical trial that will enroll subjects 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Lymphoma, B-Cell
What is being tested?
R-Chop and Roflumilast
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2024to Jan 2028
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 to 99 years
  • 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.
  • Patient has provided informed consent.
  • Patient is willing and able to comply with clinic visits and procedure outlined in the study protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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  • Life expectancy of ≥3 months.
  • Ann Arbor stage II-IV
  • NCCN-IPI risk score of ≥ 2
  • 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

  • 2. Any active malignancy other than DLBCL 3. High grade B Cell Lymphoma with rearrangements of MYC and BCL2, MYC and BCL6, and /or MYC and BCL2/BCL6 ("double-hit" or "triple-hit" DLBCL) 4. Current participation in another interventional clinical study 5. Prior allogeneic bone marrow transplant within 12 months of screening date. 6. Prior autologous stem cell transplant within 6 months of screening date. 7. Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months prior to drug dosing.
  • 8. Active central nervous system (CNS) involvement by lymphoma, including untreated symptomatic epidural disease 9. Active uncontrolled infection. 10. Poorly controlled depressive symptoms and/or currently under management for depression that is poorly controlled.
  • 11. Significant disease or medical conditions, as assessed by the Investigator and Sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV.
  • 12. Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which subjects are not on active anti-cancer therapies and have had no evidence of active malignancy for at least 1 year.
  • 13. 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.
  • 14. 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.
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  • 15. 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.
  • 16. Baseline serum troponin above the upper limit of normal. 17. Baseline serum BNP above the age-adjusted upper limit of normal. 18. Baseline amylase above the upper limit of normal. 19. Subjects 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.
  • 20. Subjects 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.
  • 21. Subjects with moderate or severe liver impairment, as defined by a Child-Pugh class of B or C.
  • 22. Women who are pregnant or breastfeeding. 23. 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.
  • 24. 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: Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy for High-risk Diffuse Large B-cell Lymphoma (CTMS# 22-0016)

This study is an investigator-initiated, phase II, single arm, open label clinical trial that will enroll subjects 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. All subjects will receive investigational drug, and outcomes will be compared to historical controls.

Being tested
R-Chop and 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.

  • R-Chop and RoflumilastDrug

    Also called Daliresp

    All subjects 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 (+/- 3 days) for a total of 6 cycles. All subjects will receive a fixed oral dose of one 500 microgram (μg) tablet of roflumilast per day with or without food for all 21 days of each cycle, which will amount to a total of 126 doses. Subjects will be asked to keep a drug diary to record the days and times when Roflumilast is taken. The first dose will be given on the day of the first R-CHOP treatment.

Study groups in NCT05796271
Study groupRoleWhat they receive
R-Chop and RoflumilastExperimentalAll subjects 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 (+/- 3 days) for a total of 6 cycles. All subjects will receive a fixed oral dose of one 500 microgram (μg) tablet of roflumilast per day with or without food for all 21 days of each cycle, which will amount to a total of 126 doses. Subjects will be asked to keep a drug diary to record the days and times when Roflumilast is taken. The first dose will be given on the day of the first R-CHOP treatment.
Receives: Drug: R-Chop and Roflumilast

What is being measured

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

  1. Anti-tumor efficacy: progression-free survival (PFS)

    To assess the change in anti-tumor efficacy of Roflumilast in combination with R-CHOP in subjects with previously untreated high-risk DLBCL who are appropriate for treatment by estimates of progression-free survival (PFS).

    Measured: Measured every 3 weeks for 21 day cycles for the duration of study treatment, from Baseline to approximately 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 posted3 Apr 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Why it stopped: Inadequate funding to begin enrolling subjects

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796271
Sponsor's protocol ID
CTMS# 22-0016
Status last verified
Feb 2024
First submitted
9 Feb 2023
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD that underlie results in publication will be shared at the end of the study.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing R-Chop and 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 20 inclusion and 12 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: withdrawn, as of the sponsor's last update on 29 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 was withdrawn before enrolling participants, so there are no results.

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?

Anti-tumor efficacy: progression-free survival (PFS) (time frame: Measured every 3 weeks for 21 day cycles for the duration of study treatment, from Baseline to approximately 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 NCT05796271.

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 29 Feb 2024.

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