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

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ClinicalTrials.gov Identifier: NCT02338232
Recruitment Status : Recruiting
First Posted : January 14, 2015
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

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
GVHD Drug: Telmisartan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : July 7, 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: 160 mg Telmisartan
60 patients will receive 160 of Telmisartan (2 80 mg tablets) for 101 days
Drug: Telmisartan
Other Name: Micardis




Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338232


Contacts
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Contact: David Schwartz, MD, PhD dschwartz@fastmail.fm

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: David Schwartz, MD. PhD Hackensack Meridian Health

Publications:
Hilmi I, Kellum J, Planinsic R, Foster D, Abdullah A, Damian D, Gligor S, Klein D, Abu-elmagd K. Endotoxemia is common following abdominal organ transplantation and is associated with reperfusion and rejection.Journal of Organ Dysfunction. Dec 2009, Vol. 5 Issue 4, p254-260.
Gomez A, Hammer S, Braun T, Hanash S, Ferrara J, Greenson J, Wang H, Zhang Q, Vander Lugt M, Pongtornpipat P, Lamiman K, Colon M, Chang L, Choi S, Levine J, Harris A, Couriel D, Reddy P, Paczesny S. A novel CD4+CD146+CCR5+ T-cell population is a biomarker of intestinal graft-versus-host disease. 39th meeting of the European Group for Blood and Marrow Transplantation Wednesday, April 10, 2013, 09:30 - 09:42
Patel PA, Patravale VB, Commercial Telmisartan Tablets: A Comparative Evaluation with Innovator Brand Micardis, International Journal of Pharma Sciences and Research (IJPSR) 2010, 1(8): 282-292.

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT02338232     History of Changes
Other Study ID Numbers: Pro5465
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action