Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Tran… (NCT02338232) | Clinical Trial Compass
TerminatedNot Applicable
Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation
Stopped: Lack of Accrual
United States32 participantsStarted 2015-07-07
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 prio…
What they're measuring
1
Number of Subjects With Grade 3 or Greater Acute Graft vs. Host Disease (GVHD) in Patients Receiving Allogeneic HCT.