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

NCT ID: NCT02338232

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-07
• Study Completion Date: 2023-01-05

Brief 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.

Detailed 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.

Conditions

GVHD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

160 mg Telmisartan

60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Interventions

Telmisartan

Intervention Type: DRUG

Other Intervention Names

Micardis

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Rowley, MD

Role: PRINCIPAL_INVESTIGATOR

Hackensack Meridian Health

Locations

Hackensack University Medical Center

Hackensack, New Jersey, United States

Countries

United States

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Document Type: Study Protocol and Statistical Analysis Plan

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Pro5465

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Identifier Source: org_study_id