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NCT02737306: GVHD
A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation
Phase 2 trial testing PRO 140 in Graft Vs Host Disease in 11 participants. Terminated before completion.
14 April 2021
Quick facts
| Lead sponsor | CytoDyn, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 14 May 2017 |
| Primary completion | 14 April 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- PRO 140 — full drug profile →
- Placebo
Conditions studied
- Graft Vs Host Disease — all drugs for Graft Vs Host Disease →
Sponsor
CytoDyn, Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Graft Vs Host Disease. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 14 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (11 terms)
| Reaction | System | PRO 140 | Placebo |
|---|---|---|---|
| Pneumonia | Infections and infestations | — | — |
| Acute graft versus host disease | Immune system disorders | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Azotaemia | Renal and urinary disorders | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — |
| Cytomegalovirus viraemia | Infections and infestations | — | — |
| Generalised tonic-clonic seizure | Nervous system disorders | — | — |
| Jugular vein thrombosis | Vascular disorders | — | — |
| Myopathy | Musculoskeletal and connective tissue disorders | — | — |
| Pyrexia | General disorders | — | — |
| Subdural haemorrhage | Injury, poisoning and procedural complications | — | — |
Other adverse events (153 terms — click to expand)
| Reaction | System | PRO 140 | Placebo |
|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| White blood cell count decreased | Investigations | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Mucosal inflammation | General disorders | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Erythema | Skin and subcutaneous tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Ear pain | Ear and labyrinth disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Oesophagitis | Gastrointestinal disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| International normalised ratio increased | Investigations | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Pneumonia, Acute graft versus host disease, Acute respiratory failure, Azotaemia, Cholelithiasis, Cytomegalovirus viraemia, Generalised tonic-clonic seizure, Jugular vein thrombosis.
Data from ClinicalTrials.gov NCT02737306 adverse events section.
Sponsor's own description
This is a Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS) Undergoing Allogeneic Stem-Cell Transplantation.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antibody therapies for the prevention and treatment of viral infections.
Salazar G, Zhang N, Fu TM, An Z. · · 2017 · cited 138× · PMID 29263875 · DOI 10.1038/s41541-017-0019-3 -
The G protein coupled receptor CCR5 in cancer.
Upadhyaya C, Jiao X, Ashton A, Patel K, et al · · 2020 · cited 17× · PMID 32089164 · DOI 10.1016/bs.acr.2019.11.001
Verify or expand the search:
- PubMed search for NCT02737306
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PRO 140
Trials testing the same drug.
- NCT03902522 — PRO 140 in Treatment-Experienced HIV-1 Subjects · Phase 2, PHASE3 · completed
- NCT02175680 — Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection · Phase 2 · completed
- NCT00110591 — Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers · Phase 1 · completed
- NCT02759042 — An Expanded Access Protocol for a Single Subject Who Has Completed 24-Weeks of Treatment in PR0140_CD02 Study · no longer available
Other recruiting trials for Graft Vs Host Disease
Currently open trials in the same condition.
- NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
- NCT06008808 — Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release S · Phase 1 · recruiting
- NCT07365696 — Fatigue and Cognitive Dysfunction Due to Synaptopathy or Graft Versus Host (GVH) Disease in the Brain. · recruiting
- NCT05621759 — Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD · Phase 2 · active not recruiting
- NCT05236062 — Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial · NA · recruiting
Other CytoDyn, Inc. trials
Trials by the same sponsor.
- NCT05730673 — Leronlimab in Combination With Regorafenib in Patients With CCR5+, Metastatic Colorectal Cancer · Phase 2 · withdrawn
- NCT04678830 — Double Blind, Placebo Controlled Study of Safety and Efficacy of Leronlimab in Patients With "Long" COVID-19 · Phase 2 · completed
- NCT04521114 — Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis · Phase 2 · completed
- NCT04504942 — Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors · Phase 2 · completed
- NCT04347239 — Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19 · 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 NCT02737306 (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 CytoDyn, Inc.
- Last refreshed: 12 March 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/NCT02737306.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing