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Monoclonal Antibodies

Loncastuximab Tesirine + Rituximab for Follicular Lymphoma

Phase 2

Recruiting

Led By Juan P Alderuccio, MD

Research Sponsored by Juan P. Alderuccio, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Patients must have histologic confirmation of Follicular Lymphoma (FL) (grade 1, 2 and 3A). Participants who have received previous CD19-directed therapy must have a biopsy showing CD19 expression after completion of the therapy

Must not have

Uncontrolled intercurrent illness such as: history of Myocardial Infarction (MI) in the last 6 months, congestive heart failure New York Heart Association (NYHA) Class III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver cirrhosis, and autoimmune disorder requiring immunosuppression or long-term corticosteroids (>10 mg daily prednisone equivalent)

FL grade 3B or transformed FL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it's more effective than the current standard of care for treating follicular lymphoma.

Who is the study for?

Adults diagnosed with Follicular Lymphoma who have relapsed or not responded to treatment, and show certain disease characteristics on scans. They must be in relatively good health otherwise, with major organs functioning well and no severe illnesses that could interfere with the study.

What is being tested?

The trial is testing whether combining Loncastuximab Tesirine with Rituximab increases the complete response rate in treating Follicular Lymphoma compared to previous treatments patients may have received.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, lowered blood cell counts which can increase infection risk, liver enzyme changes suggesting liver stress, and possibly other organ-related inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I have a confirmed diagnosis of Follicular Lymphoma and if treated before, my cancer still shows CD19.

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My blood test shows more than 5,000 lymphoma cells per mm3.

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I have at least 3 lymph nodes, each larger than 3 cm.

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My organ and bone marrow functions are normal.

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I meet at least one criterion for starting treatment based on my lymphoma condition.

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I have a tumor that is 7 cm or larger.

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My scans show cancer that can be measured.

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I have had unexplained fever, night sweats, or significant weight loss recently.

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I have an enlarged spleen or a spleen lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart, liver, autoimmune issues, or a recent stroke.

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My condition is either Follicular Lymphoma grade 3B or transformed Follicular Lymphoma.

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I have fluid buildup needing drainage or causing breathing problems.

Select...

I am unable to make medical decisions for myself.

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My lymphoma has spread to my brain or spinal cord.

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I have undergone 6 or more treatments for follicular lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants achieving Complete Response (CR)

Secondary study objectives

Incidence of Treatment-Related Adverse Events

Number of participants achieving CR or PR

Overall Survival (OS)

+1 more

Side effects data

From 2022 Phase 2 trial • 145 Patients • NCT03589469

42%

Gamma-glutamyltransferase increased

40%

Neutropenia

33%

Thrombocytopenia

28%

Fatigue

26%

Anaemia

23%

Nausea

22%

Cough

20%

Blood alkaline phosphatase increased

19%

Oedema peripheral

17%

Diarrhoea

17%

Pyrexia

16%

Aspartate aminotransferase increased

16%

Hypophosphataemia

16%

Hypokalaemia

15%

Alanine aminotransferase increased

15%

Decreased appetite

14%

Leukopenia

14%

Hypomagnesaemia

13%

Vomiting

13%

Pruritus

13%

Rash

12%

Constipation

12%

Dyspnoea

11%

Abdominal pain

11%

Insomnia

10%

Asthenia

10%

Erythema

10%

Headache

10%

Pleural effusion

10%

Photosensitivity reaction

Lymphopenia

Tachycardia

Hypocalcaemia

Hyperglycaemia

Weight increased

Hypotension

Neck pain

Nasal congestion

Pain in extremity

Hypertension

Back pain

Dizziness

Hyponatraemia

Rash maculo-papular

Hypercalcaemia

Febrile neutropenia

Pain

Lung infection

Metapneumovirus infection

Rhinovirus infection

Septic shock

Soft tissue infection

Pneumonia

Urinary tract infection bacterial

Facial nerve disorder

Mental status changes

Diffuse large B-cell lymphoma

Deep vein thrombosis

Embolism

Haematoma

Postoperative hypotension

Thrombosis

Psychomotor skills impaired

Syncope

Ureterolithiasis

Haemoptysis

Pleuritic pain

Pneumonitis

Confusional state

Intentional self-injury

Acute kidney injury

Hydronephrosis

Escherichia sepsis

Fall

Ascites

Dysphagia

Small intestinal perforation

Pericardial effusion

Small intestinal obstruction

Non-cardiac chest pain

Disease progression

Face oedema

Pericarditis

Intestinal obstruction

Influenza

Klebsiella infection

Pneumonia fungal

Sepsis

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

Loncastuximab Tesirine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Loncastuximab tesirine + RituximabExperimental Treatment2 Interventions

During the 12-week Induction Phase (Cycles 1 to 4), participants will receive loncastuximab tesirine on days 1 of each 3-week cycle for Cycles 1 through 4; and rituximab on days 1, 8, 15 of Cycle 1 and day 1 of Cycle 2. Maintenance Phase 1 (Cycle 5) is 8 weeks: Participants achieving complete response (CR) or partial response (PR) during the Induction Phase will receive loncastuximab tesirine once every 3-weeks; and rituximab once during week 7 or 8. Participants achieving a response of Stable Disease (SD) or Progressive Disease (PD) will be taken off treatment. Maintenance Phase 2 (Cycles 6 and 7) is 16 weeks: * Participants achieving CR during Maintenance Phase 1 receive rituximab once during week 7 or 8 of Cycles 6 and 7. * Participants achieving PR during Maintenance Phase 1 receive loncastuximab tesirine once every 3-weeks over each 8 week cycle; and rituximab once during week 7 or 8 of Cycles 6 and 7. * Participants achieving SD or PD will be taken off treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Loncastuximab tesirine

2018

Completed Phase 2

~150