Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients (NCT05823571) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients
United States32 participantsStarted 2023-07-06
Plain-language summary
This research is being done to learn whether drug called itacitinib, which is a novel inflammation- and immune-lowering drug (immunosuppressant), can be given before and after non-myeloablative peripheral blood stem cell transplantation (PBSCT; also known as a 'mini' transplant) to help prevent certain complications such as cytokine release syndrome (CRS) for patients with blood cancers, using peripheral blood from a relative. The investigators will also examine if by using itacitinib the investigators can reduce the duration of MMF (other immune suppressive drug administration posttransplant).
Who can participate
Age range
60 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
. Acute leukemias in complete remission with minimal residual disease
. Myelodysplastic syndrome (MDS) with at least one poor-risk feature
. Chronic myelomonocytic leukemia with at least one poor-risk feature
. T-cell PLL in PR or better prior to transplantation.
. Tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase.
. Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)
. Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen
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
Number of participant deaths
Timeframe: 14 days
2
Number of participants with grade 3 or higher CRS
Timeframe: 14 days
3
Number of participants with grade 1-2 CRS that requires additional CRS-directed treatment
Timeframe: 14 days
4
Number of participants with treatment limiting toxicities by Day 60
Timeframe: 60 days
Trial details
NCT IDNCT05823571
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins