New combo therapy shows promise for kids with Transplant-Related cancer

NCT ID NCT02900976

Disease control Sponsor: Children's Oncology Group Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested a combination of rituximab (a targeted antibody) and specially trained immune cells (LMP-specific T-cells) in 18 children who developed a type of lymphoma after receiving a solid organ transplant. The goal was to see if this approach could effectively treat the cancer while being safer than standard chemotherapy. The study was completed but stopped early, so results are limited.

What this could mean

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

Active substance: Rituximab and LMP-specific T-cells
What this could lead to: If it works, this could offer a targeted treatment option for children with post-transplant lymphoma, potentially reducing the need for stronger chemotherapy.
What could go wrong: This was a very small pilot study (18 participants) that stopped early, so results are limited. The treatment may not work for everyone and could cause immune reactions or other 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Mar 2017

Finished

Dec 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

Up to 29 years

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: * Patient must have a history of solid organ transplantation * 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 * There must be evaluable disease at study entry either by imaging or by serial endoscopic biopsies. * Note: a measurable node must have an LDi (longest diameter) greater than 1.5 cm; a measurable extranodal lesion should have an LDi greater than 1.0 cm; all tumor measurements must be recorded in millimeters (or decimal fractions of centimeters) * Patients must be considered medically refractory to decreased immunosuppression (50% or greater reduction) for at least 1 week or there must be documentation in the medical chart that decreased immunosuppression would be associated with an unacceptable risk of rejection * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1 * Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Patients must have a life expectancy of \>= 8 weeks * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study * COHORT A and B: Patient must not have received therapy with anti-CD20 monoclonal antibodies within 90 days of entry onto this study * COHORT C: Patient must have received rituximab at 375 mg/m\^2 weekly for at least 3 doses within the last 90 days prior to study enrollment * Must not have received any prior radiation to any sites of measurable disease * Must not have received any prior stem cell transplant * Must not have received investigational therapy within 30 days of entry onto this study * Must not have received prior EBV or LMP-specific T cells within 90 days of entry onto this study * Must not have received alemtuzumab or other anti-T-cell antibody therapy within 28 days of entry onto this study * COHORT C: HLA typing is available and will be submitted at the time of enrollment. Exclusion Criteria: * Burkitt morphology * Central nervous system (CNS) involvement; CNS status must be confirmed by lumbar puncture * Note: lumbar puncture can be performed at the time of diagnosis and does not need to be repeated unless there is a change in neurological status or it was performed more than 14 days prior to study entry * Bone marrow involvement (\> 25%) * Note: bone marrow aspiration/biopsy can be performed at the time of diagnosis and does not need to be repeated unless there is a change in peripheral blood counts or it was performed more than 14 days prior to study entry * 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

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Conditions

The condition(s) this trial relates to.

post-transplant lymphoproliferative disease

As listed by the trial registrant

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

Contacts and locations

Locations

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States
C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, 30329, United States
Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Hospital Los Angeles

Los Angeles, California, 90027, United States
Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States
Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States
Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States
Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Loma Linda University Medical Center

Loma Linda, California, 92354, United States
Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304, United States
Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States
Phoenix Childrens Hospital

Phoenix, Arizona, 85016, United States
Primary Children's Hospital

Salt Lake City, Utah, 84113, United States
Riley Hospital for Children

Indianapolis, Indiana, 46202, United States
Seattle Children's Hospital

Seattle, Washington, 98105, United States
UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States
UF Health Cancer Institute - Gainesville

Gainesville, Florida, 32610, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States

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