Pasireotide in Prevention of GI Toxicity (NCT02215070) | Clinical Trial Compass
CompletedPhase 2
Pasireotide in Prevention of GI Toxicity
United States37 participantsStarted 2015-01-21
Plain-language summary
The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 18 years of age or older at the time of study enrollment.
* Histologically confirmed diagnosis for which an allogeneic transplant is utilized.
* Plan to receive an allogeneic transplant from a 4-6/6 single or dual umbilical cord blood graft, or a 7-8/8 HLA-matched sibling or unrelated donor (High resolution HLA-A, B, C, DRB1).
* Meet standard criteria as defined by the institution for a myeloablative allogeneic stem cell transplantation, with myeloablative defined as using conditioning regimens containing:
* TBI ā„ 1200 cGy, or
* Busulfan ā„ 12.8mg/kg
* Patient must have given written informed consent according to FDA guidelines.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
Exclusion Criteria:
* Female patients who are pregnant or lactating, or are of childbearing potential (FCBP, defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control
* FCBP must have a current negative serum pregnancy test prior to transplant per institutional practice.
* Use of an investigational drug within 1 month prior to dosing. Concurrent enrollment on other clinical research studies that contain an interventional therapy is not permitted while subjects are receiving pasireotide or within 5 half-lives of finishing pasireotide. However, subjects may concurrently enroll in non-interventional studies (e.g. biobanking, mobiā¦
What they're measuring
1
Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide