A clinical trial for PTLD

Ongoing and looking for participants

Illustration of a diverse group of patients.

If you have EBV‑positive PTLD that didn't go away or came back after treatment, you may be a good fit for ALLELE, a clinical trial studying a treatment called tabelecleucel.

Tabelecleucel is not approved by the FDA, and its safety, effectiveness, and use have not been established.

Find a clinical trial location

What is the trial studying?

Who might be a good fit?

What does the trial involve?

Find a clinical trial location

What is the trial studying?

This clinical trial is studying a drug called tabelecleucel (pronounced tab‑el‑uh‑KLOO‑sel).

The trial tests tabelecleucel as a treatment for patients with post‑transplant lymphoproliferative disease (PTLD) that:

is positive for Epstein-Barr virus (EBV), and
didn't go away or came back after treatment.

Doctors also call this condition relapsed or refractory (R/R) EBV‑positive PTLD.

The name of this clinical trial is ALLELE (pronounced uh‑LEEL).

What is tabelecleucel?

Tabelecleucel is an investigational medicine made of cells that fight EBV, called EBV‑Cytotoxic T Lymphocytes (EBV‑CTLs). These cells are collected from healthy donors who are immune to EBV to create a bank of cells.

From this bank, tabelecleucel is appropriately matched to patients needing treatment. Tabelecleucel is not genetically modified. Tabelecleucel is an immunotherapy, and not a chemotherapy.

Why is this clinical trial important?

While there are currently a number of ways to treat EBV‑positive PTLD, none of them are approved by the FDA (Food and Drug Administration) for treating this condition.

The results of this trial are important for the process of tabelecleucel becoming the first treatment to achieve FDA approval for EBV‑positive PTLD. Approval could give patients in the US a non‑chemotherapy option if their disease didn't go away or came back after initial treatment.

STATUS

Ongoing and looking for participants of all ages

Who might be a good fit?

PHASE

Phase 3

What does this mean?

ClinicalTrials.gov ID

NCT03394365

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ALLELE is an ongoing clinical trial. This printable PDF summarizes how tabelecleucel has worked for patients in the trial so far, as well as the side effects they experienced.

See the trial results so far

Who might be a good fit?

To know if you're a good fit, the clinical trial team will need to review your full medical history, including current and past medications. There will also be additional tests to get a full picture of your health.

Below is a summary of who may or may not be a good fit for ALLELE.

The ALLELE trial is looking for adults and children of all ages who:

Have had an allogeneic hematopoietic stem cell transplant AND have EBV‑positive PTLD that didn't respond or came back after rituximab

OR

Have had a solid organ transplant AND have EBV‑positive PTLD that didn't respond or came back after rituximab or after rituximab and chemotherapy

The ALLELE trial may not be right for people who:

Have certain conditions, including:

Burkitt lymphoma
classical Hodgkin lymphoma
any T‑cell lymphoma
graft‑versus‑host disease (GvHD)

Have untreated central nervous system (CNS) PTLD or are actively being treated for CNS PTLD

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If you have CNS PTLD, ask your doctor about the NCT04554914 trial.

Are breastfeeding, pregnant, able to get pregnant, or not willing to use a highly effective form of contraception

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Talk to your doctor if you have questions or would like to get in touch with a clinical trial team.

Find a clinical trial location

What does the trial involve?

First, the clinical trial team will fully explain what happens in the trial and answer any questions you may have. This process is called informed consent.

Participation in the trial is voluntary, and you may stop your participation at any time.

If you decide to participate in the ALLELE trial, you can expect trial‑related tests or procedures in 3 stages.

Select a stage to learn more:

Review each stage to learn more:

Screening

Timing: varies

In this stage, the clinical trial team will make sure you are a good fit.

Medical check

The trial team will look at your medical history and current health. The team may run additional tests and scans to make sure your records are complete and up to date.

Tabelecleucel matching

The clinical trial team will check the bank of cells to see if there is an appropriate match available for you. Tabelecleucel matching is based on certain cell markers called HLAs (human leukocyte antigens). If no match is available, your doctor will discuss your options with you.

Treatment

Timing: 35 days per cycle

Tabelecleucel is given in treatment cycles. Within each treatment cycle, you will receive 3 doses of tabelecleucel. You will receive one or more cycles of tabelecleucel, depending on how well your PTLD responds to treatment.

Treatment days

You will receive a dose of tabelecleucel on days 1, 8, and 15 of each 35-day cycle. On these treatment days, the trial team will first check your health. Each tabelecleucel dose is given by infusion into a vein and takes around 5 to 10 minutes. Afterwards, the trial team will monitor you closely for about an hour.

Observation and assessment

Within 7 days before the next cycle, the trial team will run a series of tests to see how well your PTLD is responding to treatment.

Next steps

Based on this assessment, the trial team will either:

repeat the treatment cycle,
adjust the next cycle, or
end treatment.

Follow-up

Timing: minimum 12 months after you start tabelecleucel

The clinical trial team will continue to keep track of how you are doing after you’ve stopped or completed treatment with tabelecleucel.

You will have in-person appointments at the clinical trial location at the following milestones after the date of your last dose:

1 month
every 3 months

Follow-ups may continue longer if you respond to treatment. Your trial team or doctor will let you know about any adjustments to the follow-up schedule.

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Ask your doctor or clinical trial team if you have any questions about the steps and procedures in the trial.

It's important to understand what happens in the trial and your rights before agreeing to participate.

Learn more about how the steps in clinical trials are planned, and your rights as a participant here.

Find a clinical trial location

Use the tools below to find an ALLELE trial location that's nearest to you. If you are interested in participating in this clinical trial, talk to your doctor.

The tool below lists US clinical trial locations only. For a full list of clinical trial locations,
including non-US locations, visit ClinicalTrials.gov.

Choose a state:

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Contact:

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A clinical trial for PTLD

What is the trial studying?

What is tabelecleucel?

Why is this clinical trial important?

Phase 3

Who might be a good fit?

The ALLELE trial is looking for adults and children of all ages who:

The ALLELE trial may not be right for people who:

What does the trial involve?

Select a stage to learn more:

Review each stage to learn more:

Screening

Medical check

Tabelecleucel matching

Treatment

Treatment days

Observation and assessment

Next steps

Follow-up

Find a clinical trial location

Choose a state:

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