Clinical trial NCT02338232: Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation
Official title: Pilot Study of Telmisartan (Micardis) For the Prevention of Acute Graft vs. Host Disease Post Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: GVHD
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.
timeFrame: 100 days post-transplant
Secondary outcomes:
measure: Number of Subjects With Grade III-IV Hypotension as Per the National Cancer Institute's Common Terminology
timeFrame: 180 days post- transplant
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Scott Rowley, MD
role: PRINCIPAL_INVESTIGATOR
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