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New combo therapy aims to tame stem cell transplant complications

NCT ID NCT05120570

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called VIC-1911 added to standard medications to prevent graft-versus-host disease (GVHD) in 16 adults with blood cancers receiving a stem cell transplant. The goal was to find a safe and effective dose that reduces GVHD and relapse. Results are still being analyzed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VIC-1911
What this could lead to
If successful, this could lead to a safer stem cell transplant with less risk of graft-versus-host disease and relapse.
What could go wrong
This is an early-phase trial with only 16 participants, so results may not apply broadly. The drug may cause side effects or not work as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

16 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 hypersensitivity to any of the investigational products * Pregnant or breastfeeding as agents used in this study are Pregnancy Category o C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations, and Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 28 days of study registration. * Women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 60 days after the last treatment of VIC-1911 or sirolimus

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Masonic Cancer Center at University of Minnesota

    Minneapolis, Minnesota, 55455, United States

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