Actively Recruiting
Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-08-05
10
Participants Needed
2
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is developed by the investigator and is a, phase I, single arm, clinical trial that will enroll subjects with untreated diffuse large B-cell lymphoma (DLCBL) at high risk for poor outcome. The types of treatments given will be shared with participants. The aims are: 1. To assess the safety and how well the participants tolerate the treatment 2. Assess the response of the tumor to treatment to estimate complete response 3. Assess the response of the tumor to treatment to estimate progression-free survival
CONDITIONS
Official Title
Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Pathologically confirmed diffuse large B-cell lymphoma (DLBCL) not otherwise specified
- Includes DLBCL/high grade B-cell lymphoma with MYC and BCL2 rearrangements
- No prior systemic therapy for lymphoma
- Provided informed consent
- Able to comply with study visits and procedures
- ECOG performance status of 0 to 2
- Life expectancy of at least 3 months
- Ann Arbor stage II to IV
- NCCN-IPI risk score of 2 or higher
- Measurable disease with at least one lesion 1.5 cm or larger and FDG-avid lesion on PET scan
- Left ventricular ejection fraction at least 45%
- Ability to swallow oral tablets
- Agree to use contraception or abstinence during treatment and for 10 months (females) or 7 months (males) after final dose
- Female subjects of reproductive potential must have a negative pregnancy test within 7 days before starting treatment
- Meet laboratory requirements for kidney, liver, blood counts, and hemoglobin levels
You will not qualify if you...
- Allergy or intolerance to roflumilast
- Allergy or intolerance to loncastuximab
- Any active malignancy other than DLBCL
- Current participation in another interventional clinical study
- Prior allogeneic bone marrow transplant within 12 months
- Prior autologous stem cell transplant within 6 months
- Immunotherapy, chemotherapy, radiotherapy, or investigational therapy within 6 months before treatment
- Active central nervous system involvement by lymphoma
- Active uncontrolled infection
- Poorly controlled depression
- Significant medical conditions increasing risk, including recent heart attack, unstable angina, uncontrolled diabetes, significant infections, or severe heart failure
- Second malignancy except certain treated skin or prostate cancers without active disease for at least 1 year
- Major surgery within 3 weeks or minor surgery within 1 week before roflumilast
- Other medical or psychiatric illnesses compromising safety or study evaluation
- Prolonged QT interval or significant ECG abnormalities
- Elevated baseline serum troponin, BNP, or amylase
- HIV positive with multi-drug resistance, low CD4 counts, or AIDS-defining conditions
- Positive for Hepatitis B surface antigen or Hepatitis C RNA unless liver enzymes normal and no chronic hepatitis
- Moderate or severe liver impairment (Child-Pugh B or C)
- Pregnant or breastfeeding women
- Current use of specific listed medications including certain antivirals, antibiotics, antifungals, and herbal products
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital System
San Antonio, Texas, United States, 78228
Actively Recruiting
2
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
A
Adolfo Diaz Duque, MD
CONTACT
R
Ricardo E Aguiar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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