Who is sponsoring NCT01453140?

NCT01453140 is sponsored by Hackensack Meridian Health.

What drugs are being tested in NCT01453140?

Interventions in NCT01453140: Cyclophosphamide and Sirolimus, Low dose IL-2 with Cytoxan + Sirolimus, Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus, Cyclophosphamide and Sirolimus, Low dose IL-2 with Cytoxan + Sirolimus, Low dose IL-2, Vidaza, Cytoxan & Sirolimus.

What condition does NCT01453140 study?

NCT01453140 studies Graft Versus Host Disease.

Is NCT01453140 still recruiting?

NCT01453140 is currently terminated. Last updated 20 March 2026.

Are results published for NCT01453140?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-03-20 · How we verify

NCT01453140: T-REG

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I- II Study of in Vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for the Treatment of Steroid-refractory Acute Graft-versus-host Disease

Terminated Phase 1/Phase 2 Results posted Last updated 20 March 2026

What this trial tests

Phase 1/Phase 2 trial testing Cyclophosphamide and Sirolimus in Graft Versus Host Disease in 3 participants. Terminated before completion.

Timeline

1 August 2011

Primary endpoint
1 March 2012

1 July 2012

Quick facts

Lead sponsor	Hackensack Meridian Health
Phase	Phase 1/Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 August 2011
Primary completion	1 March 2012
Estimated completion	1 July 2012
Sites	1 location across United States

Drugs / interventions tested

Cyclophosphamide and Sirolimus — full drug profile →
Low dose IL-2 with Cytoxan + Sirolimus — full drug profile →
Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus — full drug profile →
Cyclophosphamide and Sirolimus — full drug profile →
Low dose IL-2 with Cytoxan + Sirolimus — full drug profile →
Low dose IL-2, Vidaza, Cytoxan & Sirolimus — full drug profile →

Conditions studied

Graft Versus Host Disease — all drugs for Graft Versus Host Disease →

Sponsor

Hackensack Meridian Health — full company profile →

Who can join

Adults 18 to 70, any sex, with Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Response Rate of Patients With Steroid-refractory Graft-versus-host Disease (GVHD) Using Cyclophospahmide and Sirolimus Combined With 3 Variations of Low-dose IL 2 and Low-dose Vidaza.
Time frame: 28 days to 100 days post transplant
The primary objective of this study is to determine the response rate of patients treated steroid-refractory graft-versus-host disease (GVHD) using cyclophospahmide and sirolimus combined with 3 variations of low-dose IL 2 and low-dose Vidaza with an outcome goal of promoting CD4+CD25+FoxP3+ Tregs.

Sponsor's own description

In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Treating human autoimmunity: current practice and future prospects.
Rosenblum MD, Gratz IK, Paw JS, Abbas AK. · · 2012 · cited 156× · PMID 22422994 · DOI 10.1126/scitranslmed.3003504
Advances and challenges in immunotherapy for solid organ and hematopoietic stem cell transplantation.
McDonald-Hyman C, Turka LA, Blazar BR. · · 2015 · cited 86× · PMID 25810312 · DOI 10.1126/scitranslmed.aaa6853
Regulatory T Cell Therapy of Graft-versus-Host Disease: Advances and Challenges.
Hefazi M, Bolivar-Wagers S, Blazar BR. · · 2021 · cited 22× · PMID 34575843 · DOI 10.3390/ijms22189676

Verify or expand the search:

Other recruiting trials for Graft Versus Host Disease

Currently open trials in the same condition.

NCT07356245 — Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma · Phase 2 · recruiting
NCT07006506 — A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant · Phase 2 · recruiting
NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
NCT06705062 — Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment · Phase 3 · recruiting
NCT06252870 — Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-trans · Phase 2 · recruiting

Other Hackensack Meridian Health trials

Trials by the same sponsor.

NCT06785402 — Ceftriaxone for Post-Treatment Lyme Disease · Phase 1, PHASE2 · recruiting
NCT06987708 — Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers · NA · not yet recruiting
NCT06575894 — Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation · NA · not yet recruiting
NCT07442669 — Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration · NA · not yet recruiting
NCT06991166 — OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01453140 (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 Hackensack Meridian Health
Last refreshed: 20 March 2026

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/NCT01453140.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing