Last reviewed · How we verify
High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Phase 2 trial testing Bortezomib in GVHD in 23 participants. Completed in 4 January 2024.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 20 June 2019 |
| Primary completion | 29 December 2022 |
| Estimated completion | 4 January 2024 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
18 and older, any sex, with GVHD. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of acute GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Cyclophosphamide and Bortezomib | 38.46 | 22 – 47 |
Rate of chronic GvHD post-transplant. All participants that received a transplant and received any prophylactic treatment will be included in the analysis.
| Group | Value | 95% CI |
|---|---|---|
| Cyclophosphamide and Bortezomib | 36.36 | 22 – 46 |
Time frame: From the start of the conditioning regimen for a minimum of 30 days after the last treatment dose (41 days total).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cyclophosphamide and Borte… |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Fever | General disorders | — |
| Syncope | Nervous system disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Cytomegalovirus Infection Reactivation | Infections and infestations | — |
| COVID Infection | Infections and infestations | — |
| Blood Bilirubin Increased | Investigations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Hypotension | Vascular disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Confusion | Psychiatric disorders | — |
| Death | General disorders | — |
| BK Viremia | Infections and infestations | — |
| Adenovirus | Infections and infestations | — |
| Methemoglobinemia | Blood and lymphatic system disorders | — |
| Sepsis | Infections and infestations | — |
| Reaction | System | Cyclophosphamide and Borte… |
|---|---|---|
| Platelet Count Decreased | Investigations | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Urinary Tract Infection | Infections and infestations | — |
| Viremia | Infections and infestations | — |
| Alanine Aminotransferase Increased | Investigations | — |
| Aspartate Aminotransferase Increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Mucositis Oral | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Agitation | Psychiatric disorders | — |
| Alkaline Phosphatase Increased | Investigations | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Bacteremia | Infections and infestations | — |
| Bloating | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Epstein-Barr virus infection reactivation | Infections and infestations | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — |
| Gastric Hemorrhage | Gastrointestinal disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hypertension | Vascular disorders | — |
| Hypoxia | Infections and infestations | — |
| C. Difficile | Infections and infestations | — |
| Pain | General disorders | — |
| Secretions | Respiratory, thoracic and mediastinal disorders | — |
| Sinus Tachycardia | Cardiac disorders | — |
| Skin Ulceration | Skin and subcutaneous tissue disorders | — |
| Sore Throat | Respiratory, thoracic and mediastinal disorders | — |
| Upper Gastrointestinal Hemorrhage | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
Most-reported serious reactions: Anemia, Fever, Syncope, Abdominal Pain, Cytomegalovirus Infection Reactivation, COVID Infection, Blood Bilirubin Increased, Fall.
Data from ClinicalTrials.gov NCT03945591 adverse events section.
This is a single arm open label phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from matched-related or unrelated donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity or myeloablative conditioning regimen of fludarabine, busulfan, and rabbit anti-thymocyte globulin (rATG). Patients will receive PTCyBor as GvHD prophylaxis.
4 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
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/NCT03945591.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing