Study on Loncastuximab Tesirine and Rituximab for Treating Relapsed or Hard-to-Treat Follicular Lymphoma

Sponsor: Juan P. Alderuccio, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04998669

Provider View

This clinical trial is testing whether a combination of two drugs, Loncastuximab Tesirine and Rituximab, can improve treatment outcomes for patients with follicular lymphoma that has returned or is not responding to previous treatments.

Patient Parameters

Program Overview

The aim of this study is to determine if using Loncastuximab Tesirine together with Rituximab can increase the rate of complete response in patients with follicular lymphoma, a type of blood cancer, that has either come back after treatment or has not responded to previous therapies.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Diagnosed with follicular lymphoma (FL) grades 1, 2, or 3A. If previously treated with CD19-directed therapy, a biopsy must show CD19 expression after treatment.
  • Have relapsed or refractory FL after at least one previous treatment and meet specific criteria for needing further therapy, such as disease progression within 24 months or a second relapse.
  • Scans must show positive lesions that match tumor sites, with at least one measurable site of disease.
  • Meet at least one of the following criteria for treatment:
    • Involvement of 3 or more lymph nodes, each 3 cm or larger.
    • Any tumor mass 7 cm or larger.
    • Symptoms like fever, night sweats, or significant weight loss.
    • Risk of symptoms that could affect organs.
    • Enlarged spleen or spleen lesions.
    • Low white blood cell count or high lymphoma cell count in the blood.
    • Bone lesions visible on scans.
  • Disease progression or relapse within 24 months of initial treatment, or a second relapse after at least one treatment.
  • Performance status score of 2 or less, indicating ability to carry out daily activities.
  • Life expectancy of more than 6 weeks.
  • Normal organ and bone marrow function, with specific blood count and liver function levels.

Exclusion Criteria

  • Follicular lymphoma grade 3B or transformed FL.
  • More than 6 previous lines of treatment for FL.
  • Significant fluid buildup in the chest or abdomen causing symptoms.
  • Currently receiving other experimental treatments.
  • Known involvement of the central nervous system by lymphoma.
  • Uncontrolled health issues like recent heart attack, severe heart failure, irregular heartbeat, recent stroke, liver cirrhosis, or autoimmune disorders needing strong medication.
  • Pregnant or breastfeeding women.
  • Active hepatitis B or C infection. Patients with certain positive hepatitis tests must have a negative PCR test to participate.
  • History of HIV infection.
  • Difficulty making informed decisions.

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