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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

Must not have

Fulminant PTLD defined as: fever > 38 degrees Celsius (C), hypotension, and evidence of multi-organ involvement/failure including two or more of the following: Bone marrow (including pancytopenia without any detectable B-cell proliferation), Liver (coagulopathy, transaminitis and/or hyperbilirubinemia), Lungs (interstitial pneumonitis with or without pleural effusions), Gastrointestinal hemorrhage, Any documented donor-derived PTLD, Hepatitis B or C serologies consistent with past or current infections because of the risk of reactivation with rituximab, Severe and/or symptomatic refractory concurrent infection other than EBV, Pregnant females are ineligible since there is no available information regarding human fetal or teratogenic toxicities, Lactating females are not eligible unless they have agreed not to breastfeed their infants, Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained, Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 12 months following completion of study therapy., All patients and/or their parents or legal guardians must sign a written informed consent, All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Bone marrow involvement (> 25%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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More than a quarter of my bone marrow is affected.

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My cancer has Burkitt-like features.

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My CNS condition was confirmed with a spinal tap.

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

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

Primary study objectives

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 study objectives

Absence of Epstein-Barr Virus Viremia

Event-free Survival (EFS)

Incidence of Adverse Events

+5 more

Awards & Highlights

No Placebo-Only Group

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

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

~2990

0 / 11Eligibility criteria met