Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation

GVHD Clinical Trial

Official title:

Pilot Study of Telmisartan (Micardis) For the Prevention of Acute Graft vs. Host Disease Post Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02338232
• Other study ID #: Pro5465
• Status: Terminated
• Phase: N/A
• Start date: July 7, 2015
• Est. completion date: January 5, 2023

Study information

• Verified date: April 2024
• Source: Hackensack Meridian Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 5, 2023
• Est. primary completion date: January 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Diagnosis of:
• Acute myeloid or lymphoid leukemia in remission,
• Myelodysplastic syndrome,
• Chronic lymphoid leukemia,
• Non-Hodgkin lymphoma,
• Hodgkin lymphoma,
• Chronic myeloid leukemia in chronic or accelerated phase,
• Myeloproliferative disorder, or
• Multiple myeloma
• Undergoing allogeneic HSC transplantation from a related or unrelated donor matched at least at 7 of 8 of the HLA-A, -B, -C, and DR loci ("8/8" or "7/8" match)
• 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:

• Busulfan 130 mg/m2 iv daily x 2 (reduced intensity) or 4 days
• TBI 150 cGy bid x8 doses (1200 Gy)
• Melphalan 140 mg/m2. (Although melphalan is not a myeloablative regimen, it results in clinically significant mucositis and patients receiving this medication will be of considerable interest in the analysis of these data.)
• Male or female patient age 18 years or older
• Karnofsky performance status > 70% at time of initiation of pre-transplant conditioning
• Transplantation-specific co-morbidity score of <5 at time of initiation of pre-transplant conditioning
• Patients taking antihypertensive medications (including telmisartan) are eligible but the patient must discontinue treatment at least 48 hours prior to first dose of study medication
• Capable of giving informed consent and having signed the informed consent form

Exclusion Criteria:

• Inability to provide informed consent
• Subjects with known heart failure, advanced renal impairment requiring renal replacement therapy, or liver failure although these patients would most likely not be eligible for HCT.
• Subjects taking ACE inhibitors, potassium supplements, or spironolactone (or any other potassium-sparing diuretics) who cannot discontinue use prior to initiation of study treatment OR who require a high-potassium diet
• Patient unable to discontinue current hypertension medication for medical or other reasons for two days prior to starting telmisartan
• Chronic symptomatic hypotension, volume depletion.

Related Conditions & MeSH terms

• GVHD

Intervention

Drug:
• Telmisartan

Locations

Country	Name	City	State
United States	Hackensack University Medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

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* Note: There are 111 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.		100 days post-transplant
Secondary	Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology		180 days post- transplant