Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR-CHOP) for Naïve High-Risk Diffuse Large B-cell Lymphoma (DLBCL)

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT06977711
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Loncastuximab — DRUG
    Intravenous (IV) administration 0.15 mg/kg day 1 cycles 1-2, and 0.075mg/kg day 1, cycles 3-5
  • Roflumilast — DRUG
    Oral administration of 500mcg days 1-21, cycles 1-8
  • Rituximab — DRUG
    IV administration of 375mg/m2 day 1, cycles 1-8
  • Cyclophosphamide — DRUG
    IV administration of 750mg/m2 day 1, cycles 3-8
  • Vincristine — DRUG
    IV administration 1.4mg/m2 (max 2mg) day 1, cycles 3-8
  • Doxorubicin — DRUG
    IV administration 50mg/m2 day 1, cycles 3-8
  • Prednisone — DRUG
    Oral administration 100mg/days 1-5, cycles 3-8

Study Details

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

Key Dates

Start date
Jun 20, 2025
Status verified
Jul 2025
Primary completion
Apr 15, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Untreated High Risk DLBCL (Diffuse Large B-cell Lymphoma)
    Eligible subjects will receive 2 cycles of chemotherapy free therapy composed of Loncastuximab 0.15 mg/kg, Rituximab 375 mg/m2, and Roflumilast 500 ug po daily; followed by 6 cycles of chemoimmunotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) at standard of care (SOC) doses, and Roflumilast 500 ug po daily. Loncastuximab at a dose of 0.075 mg/kg will be added to other chemoimmunotherapy agents only for the first three (3) out of six (6) cycles

Primary Outcome Measure

Estimation of number of adverse events [ Time Frame: Baseline up to 8 cycles (up to 24 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University Hospital SystemSan AntonioTexas78228
Ricardo Aguiar, MD, PhD
[email protected]
210-567-4860
Adolfo E Diaz Duque, MD, MSc
[email protected]
210-450-5904
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research CenterSan AntonioTexas78229
Ricardo Adolfo Diaz Duque, MD, MSc
[email protected]
210-450-5904
Ricardo E Aguiar, MD, PhD
[email protected]
210-567-4860

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By research site
University Hospital System· San Antonio, TXUniversity of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center· San Antonio, TX

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