Trial Outcomes & Findings for Rituximab and LMP-Specific T-Cells in Treating Pediatric Solid Organ Recipients With EBV-Positive, CD20-Positive Post-Transplant Lymphoproliferative Disorder (NCT NCT02900976)

Last Updated: 2026-01-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Day 8 of the first LMP-TC cycle (cycle = 42 days)

Results posted on

2026-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (RTX) Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction. Rituximab: Given IV	Arm II (LMP-TC) 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. Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV Rituximab: Given IV
Overall Study STARTED	2	16
Overall Study COMPLETED	2	7
Overall Study NOT COMPLETED	0	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (RTX) Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction. Rituximab: Given IV	Arm II (LMP-TC) 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. Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV Rituximab: Given IV
Overall Study Adverse Event	0	1
Overall Study Physician Decision	0	2
Overall Study Progressive disease	0	6

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (RTX) n=2 Participants Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction. Rituximab: Given IV	Arm II (LMP-TC) n=16 Participants 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. Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV Rituximab: Given IV	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=25 Participants	14 Participants n=25 Participants	16 Participants n=50 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=25 Participants	2 Participants n=25 Participants	2 Participants n=50 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Age, Continuous	6 years STANDARD_DEVIATION 7.1 • n=25 Participants	10.1 years STANDARD_DEVIATION 6.4 • n=25 Participants	9.6 years STANDARD_DEVIATION 6.4 • n=50 Participants
Sex: Female, Male Female	2 Participants n=25 Participants	6 Participants n=25 Participants	8 Participants n=50 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	10 Participants n=25 Participants	10 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=25 Participants	3 Participants n=25 Participants	4 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=25 Participants	11 Participants n=25 Participants	12 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	2 Participants n=25 Participants	2 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants	1 Participants n=25 Participants	1 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	1 Participants n=25 Participants	4 Participants n=25 Participants	5 Participants n=50 Participants
Race (NIH/OMB) White	1 Participants n=25 Participants	8 Participants n=25 Participants	9 Participants n=50 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	3 Participants n=25 Participants	3 Participants n=50 Participants
Region of Enrollment United States	2 participants n=25 Participants	16 participants n=25 Participants	18 participants n=50 Participants

PRIMARY outcome

Timeframe: Day 8 of the first LMP-TC cycle (cycle = 42 days)

Population: 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.

Outcome measures

Outcome measures
Measure	Arm II (LMP-TC) n=15 Participants 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. Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV Rituximab: Given IV
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	86.7 Percentage of patients Interval 59.5 to 98.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Will be assessed using Kaplan-Meier estimates, for all patients combined and separately for each cohort.

Outcome measures

Outcome data not reported

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Arm I (RTX)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm II (LMP-TC)

Serious events: 6 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (RTX) Induction n=2 participants at risk Patients receive rituximab or biosimilar intravenously (IV) on days 1, 8, 15. Cycle continues for up to 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (LMP-TC) Induction n=11 participants at risk Patients receive rituximab or biosimilar intravenously (IV) on days 1, 8, 15. Cycle continues for up to 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (RTX) n=2 participants at risk Patients with newly diagnosed PTLD who achieve a complete response (CR) after induction receive additional rituximab or biosimilar as in induction. Rituximab: Given IV	Arm II (LMP-TC) n=15 participants at risk 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. Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes: Given IV Rituximab: Given IV
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/11 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	20.0% 3/15 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC
General disorders Death NOS	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/11 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	13.3% 2/15 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC
General disorders Fever	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/11 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	6.7% 1/15 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC
Immune system disorders Cytokine release syndrome	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/11 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	20.0% 3/15 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC
Infections and infestations Infections and infestations - Other, specify	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/11 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	6.7% 1/15 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC
Investigations Neutrophil count decreased	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/11 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	6.7% 1/15 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/11 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	0.00% 0/2 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC	6.7% 1/15 • Enrollment up to 5 years after enrollment The SAE table reflects NCI CTCAEs submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Not every patient from Arm LMPTC received induction therapy (refractory patients are excluded), so the denominator for Arm LMPTC Induction is less than the denominator for Arm LMPTC

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 16264470064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Must obtain prior sponsor approval
Publication restrictions are in place

Restriction type: OTHER