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Post-transplant lymphoproliferative disorder (PTLD) is a polyclonal (benign) or clonal (malignant) proliferation of lymphoid cells that develops as a consequence of immunosuppression in a recipient of a solid organ or bone marrow allograft. PTLDs comprise a spectrum ranging from early, Epstein-Barr virus (EBV)-driven polyclonal lymphoid proliferations to EBV-positive or EBV- negative lymphomas of predominantly B-cell or less often T-cell type. (WHO, 2001)
TreatmentsNo approved treatments · 2 in pipeline
Clinical Trials19 registered · 7 recruiting
Diagnosis
Biomarker and diagnostic research for post-transplant lymphoproliferative disease has been reported in the published literature.
Treatment
Compiled from FDA-approved drug records, orphan drug designations, and FDA Adverse Event Reporting System (FAERS) safety data. GeneReviews management guidance is included where available.
No approved treatments are currently available for post-transplant lymphoproliferative disease. An additional 2 compounds hold orphan drug designation.
Orphan Drug Designations
While no drugs are FDA-approved specifically for post-transplant lymphoproliferative disease, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for post-transplant lymphoproliferative disease. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name
Generic Name
Sponsor
Prognosis
Estimated prevalence: 1-5 in 10,000 (Uncommon).
Research Landscape
Sourced from ClinicalTrials.gov and PubMed. Publication types are classified using NLM-curated article metadata; research type breakdowns reflect the nature of published work for this disease.
19 clinical trials registered, 7 recruiting. Interventions under study include biologic therapy, drug therapy, procedural interventions, and other interventions. Pipeline includes 2 PHASE3, 4 PHASE2, 8 PHASE1. Research is sponsored by a mix of industry and academic institutions.
Diseases are connected by shared genes, phenotypes, therapeutic targets, and MONDO disease hierarchy. The Rare badge reflects Kisho's rarity classification — scored from authoritative sources including OMIM, Orphanet, orphan drug designations, clinical trial activity, and published prevalence data.
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
PHASE2
Reem Karmali
RECRUITING
156 publications have been identified in PubMed for post-transplant lymphoproliferative disease. Research spans Case Report / Case Series (42%), Review / Meta-Analysis (20%), and Epidemiology / Natural History (15%).
Research Type
Count
% of Total
Patient case studies
66
42%
Research summaries
31
20%
Disease patterns and progression
23
15%
Clinical study results
12
8%
Laboratory research
9
6%
New treatment approaches
7
4%
Testing and diagnosis research
6
4%
Other research
2
1%
Recent Publications
Sun Q (2026). [PMID: 41676774](https://pubmed.ncbi.nlm.nih.gov/41676774/). *Hepatobiliary Surg Nutr*. [Other]
Surma J (2026). [PMID: 42181437](https://pubmed.ncbi.nlm.nih.gov/42181437/). *Cureus*. [Case Report / Case Series]
Shimogawa T (2026). [PMID: 42144298](https://pubmed.ncbi.nlm.nih.gov/42144298/). *Transplant Proc*. [Case Report / Case Series]
A recent study explores post-transplant lymphoproliferative disorder (PTLD) occurring after successful treatment of graft-versus-host disease (GVHD) in liver transplant patients. This research highlights the complexities of managing complications in transplant recipients.
Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), has received acceptance by the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) resubmission for tabelecleucel, with a proposed indication as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the timing of FDA’s review of the resubmitted BLA and the PDUFA target action date and the potential characteristics and benefits of tab-cel; (2) the receipt of milestone and royalty payments, including the potential milestone payment upon FDA approval of the tabelecleucel BLA, and (3) the prospect of bringing tab-cel to U.S. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA’s review of tab-cel, including the risk that the resubmission of the tab-cel BLA may not address the deficiencies identified in the second complete response letter received on January 9, 2026 or other issues that may be raised by the FDA on review; and that the FDA may not act by the PDUFA target action date, may exte Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy.
A case report highlights rituximab-induced Crohn's disease-like colitis in a patient treated for post-transplant lymphoproliferative disorder associated with chronic active Epstein-Barr virus infection. This finding may inform clinicians about potential gastrointestinal complications following rituximab therapy.
A recent study published in PubMed examines the clinicopathological spectrum and outcomes of biopsy-proven post-transplant lymphoproliferative disorder following kidney transplantation. This research provides insights into the disease's characteristics and patient outcomes, contributing to the understanding of this rare condition.
