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PTCy + Sirolimus/VIC-1911 for Acute Leukemia Post-transplant Care

Phase 1 & 2
Recruiting
Led By Sherman Holtan, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of acute leukemia in complete remission, myelodysplasia with <5% blasts, myeloproliferative neoplasm/myelofibrosis with <5% marrow or circulating blasts, or chemosensitive Hodgkin or non-Hodgkin lymphoma
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to prevent GVHD and relapse after alloHCT.

Who is the study for?
This trial is for adults over 18 with certain blood disorders or lymphoma, who are in remission or have low blast counts. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception, and can't have a high risk of transplant complications (HCT-CI > 4) or hypersensitivity to the drugs used.Check my eligibility
What is being tested?
The study tests PTCy/sirolimus combined with VIC-1911 as a way to prevent graft-versus-host disease (GVHD) and relapse after stem cell transplantation from donors. It's an early phase trial where all participants receive the same treatment without comparison groups.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune suppression by sirolimus and VIC-1911 such as increased infection risk, possible liver issues indicated by restrictions on AST/ALT levels, and other risks typically associated with post-transplant medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia is in complete remission, or I have a low blast count in myelodysplasia/myelofibrosis, or my lymphoma responds well to chemotherapy.
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I am 18 years old or older.
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I am mostly able to carry out my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirm safety and obtain an estimate of long-term efficacy as measured by aGVHD assessed (Phase II)
Determine the optimal dose of VIC-1911 when given in combination with standard immunosuppressive therapy in adult patients undergoing myeloablative stem cell transplantation.
Relapsed assessment (Phase II)
Secondary outcome measures
Analyze markers of mTOR and IL-2 activity cells
Compare Graft-Versus-Host Disease-Free (GRFS) to the standard PTCY plus tacrolimus/mycophenolate mofetil regimen from MT2015-29
Compare duration of initial transplant hospitalization to patients age 18+ who received treatment on MT2015-29
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PTCy/sirolimus plus VIC-1911Experimental Treatment1 Intervention
Patients enrolled and treated with PTCy/sirolimus plus VIC-1911

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
270 Previous Clinical Trials
14,517 Total Patients Enrolled
Sherman Holtan, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

VIC-1911 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05120570 — Phase 1 & 2
Acute Leukemia Research Study Groups: PTCy/sirolimus plus VIC-1911
Acute Leukemia Clinical Trial 2023: VIC-1911 Highlights & Side Effects. Trial Name: NCT05120570 — Phase 1 & 2
VIC-1911 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05120570 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it a requirement that potential participants be over the age of 18?

"This trial is only for people aged 18 to 60. Out of the 2377 total clinical trials, 376 are for minors and 2001 are for senior citizens."

Answered by AI

How many test subjects are required for this experiment?

"Yes, if you're interested in participating in this study you may be eligible as recruitment is still open. The trial was first posted on March 17th, 2022 and updated April 12th, 2022. Right now, the study is looking for 75 patients at a single site."

Answered by AI

Is this research project still recruiting patients for participation?

"The most recent update on clinicaltrials.gov shows that this medical trial is still looking for patients. The study was first posted on March 17th, 2022 and was updated April 12th, 75 people are needed from a single location."

Answered by AI

What are the inclusionary and exclusionary criteria for this particular research project?

"This trial seeks 75 individuals aged 18 to 60 who have myelodysplastic syndromes. In addition, patients must meet at least one of the following criteria: 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. Furthermore, all participants must have a left ventricular ejection fraction ≥ 45%, AST and ALT < 2 times upper limit of normal, no active/uncontrolled infection"

Answered by AI
~25 spots leftby Mar 2025