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New drug cocktail aims to spare transplant patients from chemo

NCT ID NCT06040320

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This study tests a combination of two drugs, polatuzumab vedotin and rituximab, as a first treatment for a rare cancer called post-transplant lymphoproliferative disorder (PTLD) that can occur after an organ or stem cell transplant. The goal is to see if this combo is safe and effective enough to replace standard chemotherapy, which has harsh side effects. The trial will enroll 12 people and also explore how the tumor environment and a common virus might predict outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Polatuzumab vedotin (Polivy) and rituximab (Rituxan)
What this could lead to
If successful, this combination could offer an effective first treatment for PTLD that avoids the harsh side effects of standard chemotherapy.
What could go wrong
This is a very small, early-phase trial (12 people) focused on safety and dosing, so it is too soon to know if it works. The drugs may still cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

12 people

The number who actually took part.

Started

Oct 2023

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Previously untreated biopsy-confirmed CD20-positive monomorphic post-transplant lymphoproliferative disorder (or CD20-positive lymphoma associated with immune deficiency) arising after solid organ or hematopoietic stem cell transplant. This may be defined by either the 2016 World Health Organization classification of lymphoid neoplasms or the 2022 International consensus Classification of Mature Lymphoid Neoplasms or the 2022 World Health Organization classification. * At least 18 years of age. * ECOG performance status ≤ 3. * Adequate hematologic and organ function (unless due to underlying lymphoma per the investigator) as defined below: * Absolute neutrophil count ≥ 1.0 K/cumm * Platelets ≥ 75 K/cumm * Hemoglobin ≥ 8.0 g/dL * Total bilirubin \< 1.5 x IULN * AST(SGOT)/ALT(SGPT) \< 2.5 x IULN * Creatinine clearance \> 30 mL/min measured or by Cockcroft-Gault * Note: Patients with extensive bone marrow involvement by lymphoma and/or disease-related cytopenias may be enrolled if the following criteria are met: * ANC ≥ 0.5 K/cumm * Platelets ≥ 50 K/cumm * Hemoglobin ≥ 7.0 g/dL * The effects of polatuzumab vedotin and rituximab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a participant become pregnant or suspect pregnancy while participating in this study, the participant must inform the treating physician immediately. * Ability to understand and willingness to sign an IRB approved written informed consent document. Exclusion Criteria: * Active central nervous system involvement with lymphoma / PTLD. * Current grade ≥ 2 peripheral neuropathy. * Current ejection fraction \< 40% on transthoracic echocardiogram or multigated acquisition (MUGA) scan * Subjects with history of concurrent second cancers requiring active, ongoing systemic treatment with the following exceptions: * Patients with non-melanoma skin cancer or carcinoma in situ of the cervix will not be excluded. * Patients with previous malignancies are eligible if disease-free for \> 2 years. * Patients on long term hormonal therapy to prevent recurrence of a prior cancer (e.g., hormonal therapy for breast cancer) will not be excluded. * Currently receiving any other investigational agents or received any investigational agents during the 4 weeks prior to the first dose of polatuzumab vedotin. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to polatuzumab vedotin, rituximab, or other agents used in the study. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, fungal, viral, parasitic, or mycobacterial), interstitial lung disease, active non-infectious pneumonitis, congestive heart failure NYHA grade ≥ 3, unstable angina pectoris, or cardiac arrhythmia. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to C1D1 * Patients with HIV are eligible provided the meet the following criteria: * On antiretroviral regimen and stable on that regimen * Healthy from an HIV perspective * CD4 count \> 250 cells/mcL * Minimal anticipated interactions or overlapping toxicity with polatuzumab vedotin or rituximab * HIV viral load \< 200 copies/mm3 by standard clinical assays * Active hepatitis B infection. * Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation. * Active hepatitis C infection. * Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation. * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.