Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT02338232
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02338232
Study Brief:
Protocol Section:
NCT02338232