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

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02338232
Collaborator
(none)
32
Enrollment
1
Location
1
Arm
84.8
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of Telmisartan (Micardis) For the Prevention of Acute Graft vs. Host Disease Post Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date :
Jul 7, 2015
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects with grade 3 or greater acute graft vs. host disease (GVHD) in patients receiving allogeneic HCT. [100 days post-transplant]

    Secondary Outcome Measures

    1. Number of subjects with Grade III-IV hypotension as per the National Cancer Institute's Common Terminology [180 days post- transplant]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hackensack University Medical Center Hackensack New Jersey United States 07601

    Sponsors and Collaborators

    • Hackensack Meridian Health

    Investigators

    • Principal Investigator: Scott Rowley, MD, Hackensack Meridian Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    NCT02338232
    Other Study ID Numbers:
    • Pro5465
    First Posted:
    Jan 14, 2015
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Telmisartan

    Study Results

    No Results Posted as of Aug 26, 2021