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CAR T-cell Therapy

Rituximab + LMP-Specific T-Cells for Post-transplant Lymphoproliferative Disease

Phase 2

Waitlist Available

Led By Birte Wistinghausen

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

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

Must have

Patients must have biopsy-proven newly diagnosed, relapsed or refractory polymorphic or monomorphic PTLD using the World Health Organization (WHO) classification and that is: CD20 positive, EBV positive by Epstein-Barr virus early ribonucleic acid (RNA) (EBER) in situ hybridization (preferred) and/or LMP immunoperoxidase staining

Must not have received any prior radiation to any sites of measurable disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study Summary

This trial is testing if a combination of rituximab and LMP-specific T-cells is more effective than rituximab alone in treating pediatric patients with post-transplant lymphoproliferative disorder.

Who is the study for?

This trial is for pediatric patients who have had a solid organ transplant and are now facing EBV-positive, CD20-positive post-transplant lymphoproliferative disorder. They should not have received certain treatments like myelosuppressive chemotherapy or stem cell transplants recently, and must be in relatively good health with a life expectancy of at least 8 weeks.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Rituximab (a monoclonal antibody) combined with LMP-specific T-cells (immune cells trained to attack virus-infected tumor cells) against this type of lymphoproliferative disorder that occurs after an organ transplant.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system such as fever, weakness, infusion-related reactions from Rituximab, and potential complications from introducing engineered T-cells into the body.

Eligibility Criteria

Inclusion Criteria

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

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My PTLD diagnosis is confirmed by biopsy and tests positive for CD20 and EBV.

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I haven't had radiation on any cancer areas that can be measured.

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I haven't had chemotherapy that lowers my blood cell counts in the last 2 weeks.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have never had a stem cell transplant.

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I have had an organ transplant.

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My disease can be measured or observed with tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of Patients Assigned to Arm Latent Membrane Protein-specific T-cells (LMP-TC) With Successful LMP-specific T Cell Product Match, Were Treated Within Two Weeks of the Expected Start Date, and Received Both Weekly Doses

Secondary outcome measures

Absence of Epstein-Barr Virus Viremia

Event-free Survival (EFS)

Incidence of Adverse Events

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (LMP-TC)Experimental Treatment2 Interventions

Patients with newly diagnosed PTLD who do not achieve a CR to induction, all relapsed patients after induction, and all patients with refractory disease who received rituximab or biosimilar within 90 days according to institutional guidelines, receive allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes IV over 1- 2 minutes on days 0 and 7. Cycle continues for up to 42 days in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after first cycle of cycle allogeneic LMP1/LMP2-specific cytotoxic T-lymphocytes receive an additional cycle.

Group II: Arm I (RTX)Experimental Treatment1 Intervention

Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,135 Total Patients Enrolled

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,682 Total Patients Enrolled

Birte WistinghausenPrincipal InvestigatorChildren's Oncology Group

Media Library

Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02900976 — Phase 2

Frequently Asked Questions

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

How many people have registered for participation in this experiment?

"This clinical trial has finished recruitment and is no longer accepting participants. It was posted on March 6th 2017, with the latest edit to its information being June 2nd 2022. For those seeking alternative studies, there are currently 1972 trials for relapse-related illnesses and 405 Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes studies actively recruiting patients."

Answered by AI

In what number of facilities can this research be accessed?

"This trial has 38 participating sites, such as the University of Nebraska Medical Center in Omaha and Children's Hospital of Philadelphia. Additionally, other research centres located throughout the US are offering their services to this study."

Answered by AI

What safety considerations should be taken into account when administering Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes?

"Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes is estimated to be at a safety level 2, as this is still in the second phase of clinical trials which only provide limited evidence for its security."

Answered by AI

Are participants still welcome to join this clinical exploration?

"This research trial is no longer enrolling participants. Initially posted in March 2017 and lastly edited on June 2nd 2022, alternative studies exist for those with relapse (1972) and Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes (405)."

Answered by AI

What principal goals is this trial attempting to achieve?

"This medical investigation will measure its efficacy over 8 days of the initial LMP-TC cycle (42 day period). The primary objectives are to evaluate the proportion of patients allocated to Arm latent membrane protein-specific T cells that were treated within two weeks from their anticipated start date and received both weekly doses. Additionally, secondary goals include measuring Response Rate (RR) for Rituximab via exact two sided binomial 95% confidence intervals, RR for LMP-specific T Cells through analogous calculations, and Epstein-Barr Virus Viremia's correlation with response rate (RR), event free survival (EFS), and overall survival rates"

Answered by AI

What prior research has been done on Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes?

"The National Institutes of Health Clinical Centre first tested Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes in 1993 and since then there have been 804 trials completed. Presently, 405 studies are active with a handful based out of Omaha, Nebraska."

Answered by AI

What roles do Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes fulfill in medical treatments?

"Autologous LMP1/LMP2-Specific Cytotoxic T-Lymphocytes are frequently utilized to mitigate the effects of diffuse large b-cell lymphoma (dlbcl). Additionally, this medical intervention is known to be effective for various other types of B cell lymphomas, polyangium, and pemphigus vulgaris."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder

2017. "Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02900976.

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