Tacrolimus Cessation for Bone Marrow Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety of stopping tacrolimus earlier than usual after a bone marrow transplant. Tacrolimus typically prevents graft-vs-host disease (GVHD) after a transplant, but recent methods have reduced the risk of this complication. Individuals planning their first bone marrow transplant for certain blood cancers, such as acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), might be suitable candidates. Participants should also have a matched donor available. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking medical insights.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that stopping tacrolimus early after a bone marrow transplant can be safe. One study found that ending tacrolimus treatment sooner did not increase the risk of complications or death related to the transplant. This indicates that patients can manage this change without major issues.
Another study examined patients who reduced their tacrolimus levels early after the transplant. It found that while higher levels of tacrolimus can lower the risk of GVHD, stopping it early did not lead to more severe problems.
Overall, these findings suggest that stopping tacrolimus early might be safe for people after a bone marrow transplant, especially when combined with other treatments to prevent GVHD.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new strategy for tapering off tacrolimus in patients who have undergone a bone marrow transplant. Unlike the standard approach, which often involves maintaining higher doses of immunosuppressive drugs for extended periods, this trial tests an early taper strategy. This could potentially reduce the risk of long-term side effects associated with prolonged tacrolimus use, such as kidney damage. Additionally, the trial aims to tailor the tapering process to individual patient risk, which could make post-transplant care more personalized and potentially improve outcomes.
What evidence suggests that early cessation of tacrolimus might be an effective treatment for preventing GVHD after bone marrow transplant?
In this trial, participants will follow a risk-adapted early tacrolimus taper strategy. Research has shown that stopping tacrolimus, a medication used after a bone marrow transplant, earlier than usual might be beneficial. One study found that patients who stopped taking tacrolimus sooner experienced positive results without a higher risk of graft-versus-host disease (GVHD), a serious condition where the donor's cells attack the patient's body. Another study discovered that gradually reducing immune-suppressing drugs like tacrolimus can effectively treat a relapse after a transplant. Additionally, maintaining certain levels of tacrolimus early on can reduce the risk of severe GVHD. Overall, these findings suggest that stopping tacrolimus early could be safe with careful monitoring.12367
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with certain blood disorders like AML, MDS, MF, CMML, or CML who are in remission or have refractory disease. They must be planning their first bone marrow transplant and have a fully matched donor. Participants need good kidney function and heart health.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Initial tacrolimus dosing post-HCT, with tapering starting on day 60 and complete cessation by day 88
Follow-up
Participants are monitored for safety and effectiveness, including incidence of GVHD and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Tacrolimus
Trial Overview
The study tests stopping the drug tacrolimus earlier than usual after a bone marrow transplant to see if it's safe and feasible. Tacrolimus usually helps prevent GVHD—a common post-transplant complication—but may not be as necessary with modern prevention methods.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Initial tacrolimus dosing will be as per Standard of Care protocol. Tacrolimus is initiated at day 5 post-HCT at with initial dosing as described in Section 6.2.3, and converted to oral formulation as soon as appropriate level is achieved and the patient are able to tolerate oral dosing. Oral tacrolimus is dosed in 0.5mg increments up to two times daily. Tacrolimus levels are assessed up to three times weekly in the inpatient or outpatient setting starting 1 - 3 days after initiation to target a level of 5 - 10 ng/mL. Trough levels will be assessed as close to 12 (twice daily dosing) or 24 (daily dosing) hours as feasible after most recent dose. Starting on day 60, patients on Stratum A will taper tacrolimus by approximately 20% of pre-taper dose per week, rounded to the nearest 0.5 mg. Participants who meet criteria and will be completely off tacrolimus by day 88 (+/- 5 days).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Eurofins Viracor Biopharma
Collaborator
Citations
Shortened-Duration Tacrolimus after Nonmyeloablative ...
Thus, our present data suggest that with this particular regimen, complete cessation of tacrolimus well before day +180 (3 to 4 months earlier) not only is ...
Higher tacrolimus concentrations early after transplant ...
Higher tacrolimus concentrations early after transplant reduce the risk of acute graft-versus-host disease in reduced-intensity allogeneic stem cell ...
Efficacy of immune suppression tapering in treating relapse ...
Immune suppression tapering alone in patients who relapse early after reduced intensity conditioning allogeneic stem cell transplantation can produce durable ...
Retrospective Analysis of Tacrolimus Levels: The First 56 ...
The results of our study demonstrated that tacrolimus levels 8 to 12 ng/mL in the first 8 weeks were associated with a lower risk of grade 3 to ...
Long-term Outcomes with Nonmyeloablative HLA-Identical ...
GVHD prophylaxis with tacrolimus/MMF resulted in a low risk of acute GVHD and compared favorably with results from a concurrent trial using CSP/MMF. A ...
6.
ashpublications.org
ashpublications.org/bloodadvances/article/7/18/5554/496894/Early-cessation-of-calcineurin-inhibitors-isEarly cessation of calcineurin inhibitors is feasible post ...
Safety, measured based on the TRM, was defined as death due to complications from the transplant procedure after stem cell infusion that were ...
Prevention of the Graft-Versus-Host-Disease in Patients ...
The purpose of this pilot study is to provide preliminary data about the efficacy and the safety of the combination of tacrolimus with everolimus in the ...
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