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

ConditionDiffuse Large B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women 18 years of age or older.

Pathologically proven diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS).

No prior systemic therapy for lymphoma.

Subject has provided informed consent.

Disqualifiers

Allergy or intolerance to roflumilast.

Allergy or intolerance to loncastuximab

Any active malignancy other than DLBCL

Current participation in another interventional clinical study

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Untreated High Risk DLBCL (Diffuse Large B-cell Lymphoma)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Estimation of number of adverse events

Estimation of adverse events (AE) and serious adverse events (SAE), graded according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

Time frame
Baseline up to 8 cycles (up to 24 weeks)

Secondary outcomes

1

Estimation of complete response

Estimation of complete response (CR) as defined by complete normalization of fluorodeoxyglucose positron emission tomography (FDG-PET) uptake (Deauville score of 1 to 3) of all target lesions

Time frame
Baseline up to 8 cycles (up to 24 weeks)
2

Estimation of progression-free survival (PFS)

Estimation of progression-free survival (PFS) defined as the time from the date of registration until the date of disease progression or death as a result of any cause.

Time frame
Baseline up to 8 cycles (up to 24 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

Source ClinicalTrials.gov
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