⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of GVHD

Official Title: Phase I/II Trial of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Sitagliptin for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation

Study ID: NCT05895201

Study Description

Brief Summary: This is an open label Phase I-II study to determine the safe doses of bortezomib, sitagliptin, and PTCy (Phase I) with expansion into a phase II trial to determine efficacy in improving survival.

Detailed Description: Determine the safe doses of bortezomib, sitagliptin, and PTCy for use in expansion into a phase II trial. This is effectively the maximum tolerated dose of the drugs tested in a 3+3 design in a limited phase I portion. Phase I requires a maximum of 18 patients. Determine the efficacy of sitagliptin, bortezomib, and PTCy in improving the survival free of grade II-IV acute GVHD at day +100 from an expected 65% to 80% or more. This portion uses a Simon minimax two-stage design, testing the null hypothesis H0: p0 \< 0.65 versus the alternative hypothesis H1: p1 ≥ 0.8, where p is the probability of being alive and without grade II-IV acute GVHD at day 100 after transplantation. Using a minimax optimal stage design with a one-sided type I error set to 0.05, and a type II error rate set to 0.2 (power 80%). In the first stage, 31 evaluable patients will be entered. If 20 or fewer are alive without acute grade II-IV GVHD (i.e., 11 or more develop acute grade II-IV GvHD) by day +100, the study will be stopped in favor of the null hypothesis. On the other hand, if more than 20 are alive without grade II-IV acute GVHD by day +100, and additional 24 patients will be enrolled for a total of 55 evaluable patients. In the final analysis, if more than 41 remain alive free of grade II-IV acute GVHD (i.e., only 14 or less have developed acute grade II-IV acute GVHD by day +100), the null hypothesis will be rejected, and will conclude that the combination used for prevention of moderate to severe GVHD is worthy of further study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: