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Chemotherapy

Loncastuximab Tesirine + Chemotherapy for Lymphoma (LONCA Trial)

Phase 1

Recruiting

Led By Mehdi Hamadani, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Patients rendered no evidence of disease via surgery will be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 21 days (one cycle).

Awards & highlights

LONCA Trial Summary

This trial is testing a new cancer treatment combining loncastuximab tesirine with existing drugs to see if it is safe and effective in people with aggressive B-cell lymphoid malignancies who have not had previous treatment.

Who is the study for?

Adults over 18 with specific types of B-cell lymphoma who haven't had multiagent chemotherapy. They can have limited radiation or corticosteroid therapy, and must be physically able to perform daily activities (ECOG 0-3). Their major organs need to function well, they can't be pregnant or breastfeeding, and shouldn't have severe allergies to the study drugs.Check my eligibility

What is being tested?

The trial is testing different doses of Loncastuximab Tesirine combined with DA-EPOCH-R chemotherapy in patients with aggressive B-cell lymphomas. The goal is to find the highest dose that's safe and tolerable without causing too many side effects.See study design

What are the potential side effects?

Possible side effects include allergic reactions to medication components, liver problems due to high enzyme levels, heart issues like QT interval prolongation leading to arrhythmias, infections requiring systemic treatment, significant fluid accumulations affecting breathing.

LONCA Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My surgery removed all visible signs of cancer.

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I will use a condom during the study and for six months after the last dose if my partner can have children.

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My heart's pumping ability is normal or above.

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I have a specific type of B-cell lymphoma.

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I can care for myself but may not be able to do heavy physical work.

LONCA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 days (one cycle).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 21 days (one cycle).

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days (one cycle). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The maximum tolerated dose (MTD).

The number of dose-limiting toxicities (dose-escalation phase only).

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

LONCA Trial Design

5Treatment groups

Experimental Treatment

Group I: Loncastuximab Tesirine Dose Escalation Maximum Tolerated DoseExperimental Treatment9 Interventions

The study uses a classic 3+3 dose-escalation design. Three patients will be enrolled into a cohort receiving 0.075 mg/kg by IV. If there is no dose-limiting toxicity (DLT) seen in any of these participants, the trial will enroll additional participants into the next higher dose cohort, which is 0.12 mg/kg by IV. If one patient experiences a DLT at a specific dose, an additional three individuals will be accrued into that same dose cohort. The third dose level is 0.15 mg/kg by IV. DLTs in two or more at a specific dose level indicates that the MTD has been exceeded; dose escalation will not be pursued, and the prior dose level will be expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD. This dose will be added to this record when it is determined.

Group II: Loncastuximab Tesirine Dose Escalation 0.15 mg/kg by IV.Experimental Treatment7 Interventions

Group III: Loncastuximab Tesirine Dose Escalation 0.12 mg/kg by IV.Experimental Treatment7 Interventions

Group IV: Loncastuximab Tesirine Dose Escalation 0.075 mg/kg by IV.Experimental Treatment7 Interventions

Group V: Dose Expansion PhaseExperimental Treatment9 Interventions

Subjects will receive the recommended phase 2 dose (RP2D) identified from dose-escalation phase. This dose will be added to this record when it is determined.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Cyclophosphamide

1995

Completed Phase 3

~3770

Rituximab

1999

Completed Phase 4

~1880

Vincristine

2003

Completed Phase 4

~2910

Doxorubicin

2012

Completed Phase 3

~7940

Etoposide

2010

Completed Phase 3

~2440

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,550 Total Patients Enrolled

6 Trials studying Burkitt Lymphoma

1,029 Patients Enrolled for Burkitt Lymphoma

Mehdi Hamadani, MDPrincipal InvestigatorMedical College of Wisconsin

4 Previous Clinical Trials

200 Total Patients Enrolled

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05270057 — Phase 1

Burkitt Lymphoma Research Study Groups: Loncastuximab Tesirine Dose Escalation 0.15 mg/kg by IV., Dose Expansion Phase, Loncastuximab Tesirine Dose Escalation Maximum Tolerated Dose, Loncastuximab Tesirine Dose Escalation 0.075 mg/kg by IV., Loncastuximab Tesirine Dose Escalation 0.12 mg/kg by IV.

Burkitt Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT05270057 — Phase 1

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05270057 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Rituximab attained regulatory approval from the FDA?

"Rituximab's safety rating is 1, as it has only been trialled in Phase 1 studies with minimal evidence of effectivity or security."

Answered by AI

Is there still room for individuals to join this scientific experiment?

"As per the information hosted on clinicaltrials.gov, this particular trial is no longer enrolling participants. It was first advertised on December 1st 2022 and had its last update posted October 4th 2022. Nonetheless, there are a reported 1727 other trials that require patient recruitment at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies

Mehdi Hamadani 2023. "Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05270057.