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NCT04337827
Rituximab and Acalabrutinib in Newly Diagnosed B Cell Post Transplant Lymphoproliferative Disorder
Phase 2 trial testing Rituximab in Post-transplant Lymphoproliferative Disorder in 6 participants. Terminated before completion.
27 June 2022
Quick facts
| Lead sponsor | Deepa Jagadeesh |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 2 September 2020 |
| Primary completion | 27 June 2022 |
| Estimated completion | 19 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Rituximab — full drug profile →
- Acalabrutinib (ACALABRUTINIB) — full drug profile →
- CT scans
Conditions studied
- Post-transplant Lymphoproliferative Disorder — all drugs for Post-transplant Lymphoproliferative Disorder →
Sponsor
Deepa Jagadeesh
Who can join
18 and older, any sex, with Post-transplant Lymphoproliferative Disorder. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were assessed on all subjects from the point of Eligibility Screening (baseline) to 30 days following the last dose of the study drug (which was 10 months on average).. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (2 terms)
| Reaction | System | Rituximab and Acalabrutinib |
|---|---|---|
| Lung infection | Infections and infestations | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
Other adverse events (29 terms — click to expand)
| Reaction | System | Rituximab and Acalabrutinib |
|---|---|---|
| Fatigue | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Dizziness | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Supraventricular tachycardia | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Anal hemorrhage | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Fever | General disorders | — |
| Infections and infestations | Infections and infestations | — |
| Lung infection | Infections and infestations | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Alkaline phosphatase increased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Urinary Urgency | Renal and urinary disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — |
| Hypertension | Vascular disorders | — |
Most-reported serious reactions: Lung infection, Dyspnea.
Data from ClinicalTrials.gov NCT04337827 adverse events section.
Sponsor's own description
The purpose of this study is to evaluate how effective rituximab and acalabrutinib are when given as a combination treatment for newly diagnosed B cell post transplant lymphoproliferative disorder (PTLD). Currently there is no approved therapy for PTLD. Rituximab alone is commonly used and works in some cases, but not others. In addition, participants with PTLD have trouble tolerating therapies with large amounts of side effects due to their health conditions and medications for their transplant. Due to these reasons the study team is looking for a new treatment with novel targeted agents in order to improve outcomes and to minimize toxicity. Based on emerging data of clinical efficacy of acalabrutinib in B cell malignancies and an unmet need for novel therapies in PTLD, this study will investigate the use of rituximab and acalabrutinib in participants with newly diagnosed B cell PTLD.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Acalabrutinib: A Selective Bruton Tyrosine Kinase Inhibitor for the Treatment of B-Cell Malignancies.
Abbas HA, Wierda WG. · · 2021 · cited 30× · PMID 34055635 · DOI 10.3389/fonc.2021.668162 -
How I treat posttransplant lymphoproliferative disorder.
Amengual JE, Pro B. · · 2023 · cited 27× · PMID 37540819 · DOI 10.1182/blood.2023020075 -
Recent Advances in Adult Post-Transplant Lymphoproliferative Disorder.
Markouli M, Ullah F, Omar N, Apostolopoulou A, et al · · 2022 · cited 18× · PMID 36497432 · DOI 10.3390/cancers14235949 -
Joining Efforts for PTLD: Lessons Learned from Comparing the Approach and Treatment Strategies Across the Pediatric and Adult Age Spectra.
Montanari F, Orjuela-Grimm M. · · 2021 · cited 9× · PMID 33544319 · DOI 10.1007/s11899-021-00606-8 -
Non-Hodgkin lymphoma after pediatric kidney transplantation.
Grenda R. · · 2022 · cited 3× · PMID 34633534 · DOI 10.1007/s00467-021-05205-6
Verify or expand the search:
- PubMed search for NCT04337827
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Post-transplant Lymphoproliferative Disorder
Currently open trials in the same condition.
- NCT06040320 — Polatuzumab Vedotin (Pola) Plus Rituximab (R) in Patients With Post-transplant Lymphoproliferative Disorder (PTLD) · Phase 1, PHASE2 · recruiting
- NCT01815749 — Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent · Phase 1 · active not recruiting
Other Deepa Jagadeesh trials
Trials by the same sponsor.
- NCT04517435 — ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma · Phase 1, PHASE2 · terminated
- NCT02588651 — A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04337827 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Deepa Jagadeesh
- Last refreshed: 10 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04337827.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing