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

Hackensack Meridian Health

Status: Terminated

Conditions: GVHD

Treatments: Drug: Telmisartan

Study type: Interventional

Funder types: Other

Identifiers

NCT02338232

Pro5465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

160 mg Telmisartan

Experimental group

Description:

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

Treatment:

Drug: Telmisartan