Trial · NCT02900976

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

NCT02900976, Phase 2, Completed, Children's Oncology Group; results first posted 2022-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder. Trials, record NCT02900976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02900976

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder
NCT number: NCT02900976
Status: Completed
Phases: Phase 2
Enrollment: 18 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: EBV-Related Post-Transplant Lymphoproliferative Disorder, Monomorphic Post-Transplant Lymphoproliferative Disorder, Polymorphic Post-Transplant Lymphoproliferative Disorder, Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder, Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder, Refractory Monomorphic Post-Transplant Lymphoproliferative Disorder, Refractory Polymorphic Post-Transplant Lymphoproliferative Disorder
Interventions: Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes, Rituximab
First posted: 2016-09-15
Last updated: 2026-01-26
Results first posted: 2022-06-03

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	Day 8 of the first LMP-TC cycle (cycle = 42 days)	The percentage of patients assigned to Arm LMP-TC who had a suitable LMP-specific T-cell product, were treated within two weeks of the expected start date, and received both weekly doses in a cooperative multi-institutional setting. A statistical analysis was planned, but not performed because accrual was stopped early and the sample size required for the analysis was not reached.
Secondary	Percentage of Patients Successfully Matched to a Latent Membrane Protein (LMP)-Specific T Cell Product Derived From a Third Party LMP-specific T Cell Bank	Day 1 of the first LMP-TC cycle (cycle = 42 days)	Will be assessed using an exact one-sided binomial 95% confidence interval to get a lower bound for the actual rate.
Secondary	Progression-free Survival	Time to first occurrence of progression or death (events) or loss to follow-up or survival to analysis date (non-events), assessed 12 months from enrollment of the last patient on the study	Will be assessed using Kaplan-Meier estimates, for all patients combined and separately for each cohort.
Secondary	Event-free Survival (EFS)	Time to first occurrence of progression or death (events) or loss to follow-up or survival to analysis date (non-events), assessed 12 months from enrollment of the last patient on the study	Will be assessed using Kaplan-Meier estimates, for all patients combined and separately for each cohort.
Secondary	Overall Survival (OS)	Time to first occurrence of progression or death (events) or loss to follow-up or survival to analysis date (non-events), assessed 12 months from enrollment of the last patient on the study	Will be assessed using Kaplan-Meier estimates, for all patients combined and separately for each cohort.
Secondary	Response Rate (RR) to Rituximab	Up to week 3	Will be assessed using exact two-sided binomial 95% confidence intervals to get estimates of the response rate. Will be evaluated in Cohorts A and B only (combined and separately).
Secondary	Response Rate (RR) to LMP-specific T Cells	Up to week 6	Will be assessed using exact two-sided binomial 95% confidence intervals to get estimates of the response rate. Will be evaluated in all Cohorts combined and in each Cohort separately.
Secondary	Absence of Epstein-Barr Virus Viremia	Up to 12 months	Will be correlated with response rate (RR), event-free survival (EFS) and overall survival (OS). Using the log-rank test for EFS and OS and the exact conditional test of proportions (Fisher's exact test for RR, both for all patients combined and stratified by cohort.
Secondary	Incidence of Adverse Events	Up to 12 months	Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be described using descriptive statistics. Toxicity monitoring and analysis will be performed based on "as treated".

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	Day 8 of the first LMP-TC cycle (cycle = 42 days)	2 Arm I (RTX) patients and 1 Arm II (LMP-TC) patient who came off protocol therapy prior to Callback were excluded from this analysis.	Percentage of patients	NUMBER
SECONDARY	Percentage of Patients Successfully Matched to a Latent Membrane Protein (LMP)-Specific T Cell Product Derived From a Third Party LMP-specific T Cell Bank	Day 1 of the first LMP-TC cycle (cycle = 42 days)
SECONDARY	Progression-free Survival	Time to first occurrence of progression or death (events) or loss to follow-up or survival to analysis date (non-events), assessed 12 months from enrollment of the last patient on the study
SECONDARY	Event-free Survival (EFS)	Time to first occurrence of progression or death (events) or loss to follow-up or survival to analysis date (non-events), assessed 12 months from enrollment of the last patient on the study
SECONDARY	Overall Survival (OS)	Time to first occurrence of progression or death (events) or loss to follow-up or survival to analysis date (non-events), assessed 12 months from enrollment of the last patient on the study
SECONDARY	Response Rate (RR) to Rituximab	Up to week 3
SECONDARY	Response Rate (RR) to LMP-specific T Cells	Up to week 6
SECONDARY	Absence of Epstein-Barr Virus Viremia	Up to 12 months
SECONDARY	Incidence of Adverse Events	Up to 12 months

Source ClinicalTrials.gov

Results by group1

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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	Arm II (LMP-TC)		86.7	95% Confidence Interval 59.5 to 98.3	Percentage of patients

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (RTX)	2
Overall Study	STARTED	Arm II (LMP-TC)	16
Overall Study	COMPLETED	Arm I (RTX)	2
Overall Study	COMPLETED	Arm II (LMP-TC)	7
Overall Study	NOT COMPLETED	Arm I (RTX)	0
Overall Study	NOT COMPLETED	Arm II (LMP-TC)	9

Source ClinicalTrials.gov

Adverse events116

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Arm I (RTX) Induction	1	2
other	Anemia	Blood and lymphatic system disorders	Arm II (LMP-TC) Induction	2	11
other	Anemia	Blood and lymphatic system disorders	Arm I (RTX)	0	2
other	Anemia	Blood and lymphatic system disorders	Arm II (LMP-TC)	0	15
other	Eosinophilia	Blood and lymphatic system disorders	Arm I (RTX) Induction	0	2
other	Eosinophilia	Blood and lymphatic system disorders	Arm II (LMP-TC) Induction	0	11
other	Eosinophilia	Blood and lymphatic system disorders	Arm I (RTX)	1	2
other	Eosinophilia	Blood and lymphatic system disorders	Arm II (LMP-TC)	0	15
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm I (RTX) Induction	1	2
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm II (LMP-TC) Induction	0	11

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (RTX) Induction	0	2
Total, all-cause mortality	Arm II (LMP-TC) Induction	1	11
Total, all-cause mortality	Arm I (RTX)	0	2
Total, all-cause mortality	Arm II (LMP-TC)	3	15
Total, other adverse events	Arm I (RTX) Induction	2	2
Total, other adverse events	Arm II (LMP-TC) Induction	5	11
Total, other adverse events	Arm I (RTX)	1	2
Total, other adverse events	Arm II (LMP-TC)	3	15
Total, serious adverse events	Arm I (RTX) Induction	0	2
Total, serious adverse events	Arm II (LMP-TC) Induction	0	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38163318	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02900976

GET https://conductscience.org/api/trials/v1/NCT02900976/events?page=2

API reference For AI assistants