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

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hackensack Meridian Health; Hackensack University Medical Center
• Treatments: Telmisartan

Criteria

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.