Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug cocktail aims to tame deadly transplant complication

NCT ID NCT07249346

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests whether adding the drug ruxolitinib to standard medications (cyclophosphamide and tacrolimus) can prevent severe graft-versus-host disease (GVHD) in people receiving stem cell transplants for blood cancers like leukemia. About 124 adults will receive the drug combination after transplant. The main goal is to see if this approach improves survival without severe GVHD at 6 months.

What this could mean

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

Active substance
Ruxolitinib, Cyclophosphamide, Tacrolimus
What this could lead to
If successful, this could lead to a safer, more effective way to prevent severe graft-versus-host disease after stem cell transplants, improving survival and quality of life.
What could go wrong
This is an early phase 2 trial with only 124 people, so results may not apply to everyone. The drug combination may still cause serious side effects or fail to prevent GVHD.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

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: * Age 18.0 years or older at the time of enrollment * Patients undergoing allogeneic hematopoietic cell transplantation for one of the following indications: * Acute leukemia with no circulating blasts and with less than 5% blasts in the bone marrow * Myelodysplasia/chronic myelomonocytic leukemia with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \<5% versus 5-10% blasts in this disease). * Planned myeloablative (MAC) conditioning regimen (see eligible regimens in Section 9.2) * Patients must have a related or unrelated peripheral blood stem cell donor as follows: * Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing and must be willing to donate peripheral blood stem cells and meet institutional criteria for donation. * Unrelated donor must be an 8/8 match at HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. Unrelated donor must be willing to donate peripheral blood stem cells and meet National Marrow Donor Program (NMDP) criteria for donation. \* Donor selection must comply with 21 CFR 1271 * Cardiac function: Left ventricular ejection fraction at least 45% * Estimated creatinine clearance greater than 60 ml/min (C-G formula) * Pulmonary function: DLCO (diffusing capacity of lung for carbon monoxide) corrected for hemoglobin at least 60% and FEV1 (forced expiratory volume at one second) predicted at least 60% * Liver function: AST(Aspartate aminotransferase)/ALT(Alanine aminotransferase) \<3x Upper Limit of Normal (ULN); Total bilirubin \<2 mg/dL excluding Gilbert's syndrome or hemolysis * Karnofsky Performance Score at least 70%. * Female patients (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two (2) effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse, from the time of signing the informed consent through 12 months post-transplant. * Male patients (even if surgically sterilized), of partners of women of childbearing potential must agree to one of the following: practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 12 months post-transplant. * Plans for the use of targeted small molecule inhibitor post-transplant maintenance therapy must be disclosed upon enrollment. Planned use of investigational maintenance agents is not permitted. Planned hypomethylating agents as maintenance therapy is not permitted. Allowed maintenance includes: * FLT3 inhibitors: gilteritinib, sorafenib, midostaurin * IDH inhibitors: enasidenib, ivosidenib * BCR/ABL inhibitors: imatinib, ponatinib, dasatinib, nilotinib * Other targeted therapies may be discussed with protocol chairsVoluntary written consent obtained prior to the performance of any study-related procedure that is not a part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. * There are no restrictions based on blood counts as this intervention is being used in combination with intensive chemotherapy with intent to myeloablate. Exclusion Criteria: * Prior allogeneic transplant * Active CNS (central nervous system) involvement by malignant cells * Patients with secondary acute myeloid leukemia arising from myeloproliferative neoplasms or overlap syndromes, including CMML(chronic myelomonocytic leukemia) and MDS/MPN (myelodysplastic syndromes/myeloproliferative neoplasms) syndromes; patients with secondary acute myeloid leukemia arising from myelodysplastic neoplasm are eligible. * Patients with uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment. * Active or inadequately treated latent infection with Mycobacterium tuberculosis (i.e., TB). * Patients seropositive for human immunodeficiency virus (HIV) with detectable viral load. HIV+ patients with an undetectable viral load on antiviral therapy are eligible. * Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV). The study allows: * Positive HBV serology with undetectable viral load and ongoing antiviral prophylaxis to prevent potential HBV reactivation. * Positive HCV serology with quantitative PCR (polymerase chain reaction) for plasma HCV RNA below the lower limit of detection, with or without concurrent antiviral HCV treatment. * Arterial or venous thrombosis including DVT (deep vein thrombois), PE (pulmonary embolism), stroke, and myocardial infarction within six (6) months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia. Catheter-associated DVT is not exclusionary. * Female patients who are pregnant or lactating * Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study * Patients with prior malignancies except resected non-melanoma skin cancer or treated cervical carcinoma in situ. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \< 5 years previously must be reviewed and approved by the Protocol Officer or Chairs, qualifying as below. * the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or * the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up * the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin * Planned use of ATG or alemtuzumab in conditioning regimen * Planned use of prophylactic donor leukocyte infusions * Prior use of ruxolitinib * Prior use of immune checkpoint inhibitors (i.e., PD1, PDL1, CTLA4 modulators) within six (6) months prior to conditioning * History of congenital Long QT syndrome

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02144, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.