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 range18 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 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…
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