PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation (NCT05120570) | Clinical Trial Compass
CompletedPhase 1/2
PTCy + Sirolimus/VIC-1911 as GVHD Prophylaxis in Myeloablative PBSC Transplantation
United States16 participantsStarted 2022-03-17
Plain-language summary
This is a single-arm, phase I/II, study of PTCy/sirolimus plus VIC-1911 to prevent GVHD and relapse after Allogeneic Hematopoietic Cell Transplantation (alloHCT).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of
* acute leukemia in complete remission, or
* myelodysplasia with \<5% blasts, or
* myeloproliferative neoplasm/myelofibrosis with \<5% marrow or circulating blasts
* chemosensitive Hodgkin or non-Hodgkin lymphoma
* Age 18 years or older
* Performance status of ≥ 80% Karnofsky
* Adequate organ function within 28 days of study registration defined as:
* left ventricular ejection fraction ≥ 45%
* pulmonary function with FEV1, FVC, and DLCO ≥ 50% predicted
* AST and ALT \< 2 times upper limit of normal
* Total bilirubin \<1.5 times the upper limit of normal. If the patient is suspected of having Gilbert syndrome, they require prior approval of the medical monitor
* creatinine clearance ≥ 50cc/min
* no active/uncontrolled infection
* negative HIV, HBV and HCV
* ferritin \< 2000 ng/ml
* Patients able to tolerate oral medication
* Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment through 60 days after the last treatment of VIC-1911 or sirolimus
* Able to provide written voluntary consent prior to the performance of any research related tests or procedures
Exclusion Criteria:
* HCT-CI \> 4 or unable to receive myeloablative TBI
* Use of planned post-transplant maintenance therapy to begin prior to day +75. Patients may receive standard of care maintenance therapies starting at day
+75 or later
* Patients with a history of h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the Optimal Dose of VIC-1911 When Given in Combination With Standard Immunosuppressive Therapy in Adult Patients Undergoing Myeloablative Stem Cell Transplantation.
Timeframe: 21 days post treatment
2
Progression-free Survival
Timeframe: 1 Year
3
Relapsed Assessment (Phase I)
Timeframe: 12 months
Trial details
NCT IDNCT05120570
SponsorMasonic Cancer Center, University of Minnesota