Adults 18 to 75, any sex, with Graft vs Host Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Matched Related Transplants Who Develop Grade II-IV Acute Graft Versus Host Disease (GVHD).Primary· Day 100
The number of subjects in the matched sibling cohort who develop grades II-IV acute GVHD will be assessed by consensus criteria and graded on Bone Marrow Transplant Clinical Trials Network Manual of Procedures suggested grading sheets. Grade I is mild GVHD involving up to 25% of the subject's skin; Grade II is moderate GVHD. involving 25 to 50% of the subject's skin and can include mild changes in liver and/or mild diarrhea; Grade III is severe GVHD involving over 50% of the subject's skin. Liver involvement is likely as are stomach cramps and diarrhea; and Grade 4 is very severe GvHD. Skin ma
Group
Value
95% CI
Matched Related Donor
3
Matched Unrelated Donors Transplants Who Develop Grade II-IV Acute GVHD.Primary· Day 100
The number of subjects in the matched unrelated donor cohort who develop grade II-IV acute GVHD. Acute GVHD will be assessed by consensus criteria and graded on Bone Marrow Transplant Clinical Trials Network Manual of Procedures suggested grading sheets. Grade I is mild GVHD involving up to 25% of the subject's skin; Grade II is moderate GVHD. involving 25 to 50% of the subject's skin and can include mild changes in liver and/or mild diarrhea; Grade III is severe GVHD involving over 50% of the subject's skin. Liver involvement is likely as are stomach cramps and diarrhea; and Grade 4 is very s
Group
Value
95% CI
Matched Unrelated Donor
12
Matched Related Transplants Who Develop Grade II-IV Chronic GVHD.Secondary· 1 year
The number of subjects who develop grade II-IV chronic GVHD. Chronic GVHD diagnosis and grading I to IV will be according to National Institutes of Health (NIH) Criteria rating progressively intense symptoms involving: skin (asymptomatic to deep sclerosis, impaired mobility, ulceration, or pruritus), oral cavity (asymptomatic to symptoms limiting oral intake), eyes (asymptomatic to severe dry eye, inability to work, or loss of vision due to keratoconjunctivitis), gastrointestinal tract (asymptomatic to significant weight loss \[\>15%\] or esophageal dilation), liver (normal function to bilirub
Group
Value
95% CI
Matched Related Donor
9
Matched Unrelated Donors Transplants Who Develop Grade II-IV Chronic GVHD.Secondary· 1 year
The number of subjects who develop grade II-IV chronic GVHD. Chronic GVHD diagnosis and grading I to IV will be according to National Institutes of Health (NIH) Criteria rating progressively intense symptoms involving: skin (asymptomatic to deep sclerosis, impaired mobility, ulceration, or pruritus), oral cavity (asymptomatic to symptoms limiting oral intake), eyes (asymptomatic to severe dry eye, inability to work, or loss of vision due to keratoconjunctivitis), gastrointestinal tract (asymptomatic to significant weight loss \[\>15%\] or esophageal dilation), liver (normal function to bilirub
Group
Value
95% CI
Matched Unrelated Donor
15
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Atorvastatin Calcium (Lipitor)
Serious: 10/30 (33%)
Deaths: 0/30
Unrelated Donor
Serious: 12/39 (31%)
Deaths: 0/39
Serious adverse events (14 terms)
Reaction
System
Atorvastatin Calcium (Lipi…
Unrelated Donor
Diarrhea
Gastrointestinal disorders
—
—
Sepsis
Infections and infestations
—
—
Myocardial infarction
Cardiac disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Lung infection
Infections and infestations
—
—
Bilirubin increased
Investigations
—
—
Neutrophil count decreased
Investigations
—
—
Hyperglycemia
Metabolism and nutrition disorders
—
—
Bone pain
Musculoskeletal and connective tissue disorders
—
—
Myalgia
Musculoskeletal and connective tissue disorders
—
—
Delirium
Psychiatric disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Hypotension
Vascular disorders
—
—
Other adverse events (140 terms — click to expand)
Hematopoietic stem cell transplantation is a procedure in which a person receives blood forming stem cells from a person called a "donor." The stem cells can be obtained from the hollow part of the hip bone or from blood.
A serious problem with this treatment is graft-versus-host disease (GVHD). This happens when stem cells from the donor attack normal cells of the recipient. Currently, there is no universal standard of care in the United States to prevent GVHD.
This study is being done to see if a medicine that is used to lower cholesterol can also help in reducing GVHD.
Patients will receive atorvastatin daily by mouth starting 14 days before stem cell transplant. They will continue to take atorvastatin until 180 days after transplant. This medicine may be stopped earlier if there is a bad side effect or a severe GVHD. Patients will also receive standard treatment to prevent GVHD. Patients will undergo many tests that are standard for their treatment at West Virginia University (WVU), including blood tests to check blood counts, kidney function and HIV status; blood test to check for pregnancy; Multi Gated Acquisition Scan (MUGA scan)or echocardiogram to test heart function; lung function testing; and bone marrow aspirate or biopsy. Patients will also have the option to provide blood samples for optional research related to the study.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT00687271 — A Study of MK-6213 Co-Administered With Atorvastatin in Participants With Hypercholesterolemia (MK-6213-006)
· Phase 2
· completed
Other recruiting trials for Graft vs Host Disease
Currently open trials in the same condition.
NCT07184853 — Ruxolitinib Plus Etanercept vs Ruxolitinib for Steroid-Refractory Severe Acute GVHD
· NA
· recruiting
NCT06568328 — Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
· Phase 1
· recruiting
NCT05531786 — Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) Af
· Phase 1, PHASE2
· recruiting
NCT02105766 — Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Bet
· Phase 2
· active not recruiting
Other Mehdi Hamadani trials
Trials by the same sponsor.
NCT02250300 — MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation
· Phase 1, PHASE2
· completed
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 Mehdi Hamadani
Last refreshed: 15 May 2023
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/NCT01665677.