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

February 24, 2023 updated by: Hackensack Meridian Health

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 160 mg Telmisartan
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Drug: Telmisartan
Other Names:
  • Micardis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
100 days post-transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with Grade III-IV hypotension as per the National Cancer Institute's Common Terminology
Time Frame: 180 days post- transplant
180 days post- transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2015

Primary Completion (Actual)

January 5, 2023

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro5465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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