An interventional study of Telmisartan in GVHD, sponsored by Hackensack Meridian Health. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-02.
Sponsored by Hackensack Meridian Health · Not applicable, Interventional, and Treatment
This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy.
This is single-center, open-label, prospective study of telmisartan for the prevention of acute GVHD in approximately 60 subjects undergoing allogeneic HCT for treatment of a hematologic malignancy. Subjects will receive 160 mg Micardis brand telmisartan once daily, starting 2 days prior to HCT (day -2). Once the patient is discharged post-HCT, treatment will continue through Day +98 post-HCT for a total of 101 days. After treatment discontinuation on or before day +98 post-HCT, subjects will be followed for up to 6 months for primary and secondary endpoints.
Hackensack Meridian Health is the lead sponsor of 111 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 11 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of:
Undergoing allogeneic HSC transplantation after a myeloablative TBI-, busulfan-, or (non-myeloablative) melphalan-based pre-transplant conditioning regimen. Regimens for transplantation will include at one of the following agents, given in conjunction with fludarabine or cyclophosphamide:
Exclusion Criteria:
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Drug: Telmisartan
Also known as: Micardis
Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.
Time frame: 100 days post-transplant
Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology
Time frame: 180 days post- transplant
| Milestone | 160 mg Telmisartan |
|---|---|
| Started | 32 |
| Completed | 21 |
| Not completed | 11 |
| Withdrew: Screen failure | 3 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Adverse event | 2 |
| Participants | 160 mg Telmisartan |
|---|---|
| Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT. | 1 |
| Participants | 160 mg Telmisartan |
|---|---|
| Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology | 6 |
Collected over From time of consent through +180 days post transplant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 160 mg Telmisartan | 6/29 (20.7%) | 8/29 (27.6%) | 24/29 (82.8%) |
| Event | 160 mg Telmisartan |
|---|---|
| HospitalizationGeneral disorders | 3/29 |
| SepsisInfections and infestations | 2/29 |
| PainGeneral disorders | 1/29 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/29 |
| Primary Graft FailureBlood and lymphatic system disorders | 1/29 |
| Event | 160 mg Telmisartan |
|---|---|
| HypotensionVascular disorders | 12/29 |
| DiarrheaGastrointestinal disorders | 7/29 |
| DysgeusiaNervous system disorders | 6/29 |
| NauseaGastrointestinal disorders | 6/29 |
| VomitingGastrointestinal disorders | 6/29 |
| AnorexiaMetabolism and nutrition disorders | 5/29 |
| GVHD (Skin)Immune system disorders | 5/29 |
| MucositisGastrointestinal disorders | 5/29 |
| PruritusSkin and subcutaneous tissue disorders | 4/29 |
| BK ViremiaInfections and infestations | 3/29 |
Patients receiving Investigational Product not including screen failures
| Age, Categorical(Participants) | 160 mg Telmisartan |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 24 |
| >=65 years | 5 |
| Age, Continuous(Years) | 160 mg Telmisartan |
|---|---|
| Median | 54.33 (23.51 to 73.1) |
| Sex: Female, Male(Participants) | 160 mg Telmisartan |
|---|---|
| Female | 10 |
| Male | 19 |
| Ethnicity (NIH/OMB)(Participants) | 160 mg Telmisartan |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 25 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | 160 mg Telmisartan |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 25 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | 160 mg Telmisartan |
|---|---|
| United States | 29 |
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This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Hackensack Meridian Health