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New drug cocktail aims to tame deadly transplant complication

NCT ID NCT02891603

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding pacritinib to standard immune-suppressing drugs (sirolimus and tacrolimus) could prevent graft-versus-host disease (GVHD) in 40 patients receiving stem cell transplants for blood cancers. GVHD occurs when donor immune cells attack the recipient's body. The trial measured immune cell activity and tracked how many patients developed GVHD. Results could lead to safer transplant procedures.

What this could mean

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

Active substance
Pacritinib and Sirolimus
What this could lead to
If successful, this approach could reduce the risk of serious GVHD after stem cell transplants, making the procedure safer for patients.
What could go wrong
This is an early-phase trial with only 40 participants, so results may not apply to everyone. The drug combo also carries risks like infection or side effects.

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

40 people

The number who actually took part.

Started

Jun 2017

Finished

Apr 2022

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: * Must have an available 8/8 HLA-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft. * Signed informed consent. * Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloproliferative neoplasms, Hodgkin lymphoma, or non-Hodgkin lymphoma requiring a matched allogeneic hematopoietic stem cell transplantation (HSCT). Acute Leukemia (AML or ALL) must be in complete remission defined as: \<5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow \>20% cellular, and peripheral absolute neutrophil count \>1000/uL (platelet recovery is not required). Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have \<5% marrow blasts. Myeloproliferative neoplasms (MPN): Must have \<5% peripheral / marrow blasts. Note: Prior use of a JAK2 inhibitor is allowed up to 4 weeks before day 0 of alloHCT. Hodgkin and non-Hodgkin lymphoma: Must have chemosensitive disease. * Adequate vital organ function. * Performance status: Karnofsky Performance Status Score ≥ 80%. Donor Eligibility: * Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing as defined by the Collaborative Trials Network. Exclusion Criteria: * Active infection not controlled with appropriate antimicrobial therapy. * History of HIV, hepatitis B, or active hepatitis C infection. * Anti-thymocyte globulin, alemtuzumab, bortezomib, or post-transplant cyclophosphamide as part of GVHD prophylaxis. * Sorror's co-morbidity factors with total score \>4. * Any patient anticipating or scheduled to receive a tyrosine kinase inhibitor, FLT3 inhibitor, or JAK2 inhibitor (outside of this study) post-HCT. * QTc\>450ms per Fridericia's correction. * Thrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) \>2x upper limit of normal (ULN). * Grade 3 or higher recent (within the past 6 months) or ongoing non-QTc cardiac adverse events/comorbidities. * Grade 3 or higher recent or ongoing cardiac dysrhythmias, family history of long QT. syndrome, or serum potassium \<3.0 mEq/L that is persistent and refractory to correction. * Grade 3 or higher recent or ongoing bleeding events. * Symptomatic or uncontrolled cardiovascular disease, myocardial infarction or severe/unstable angina within the past 6 months, or New York Heart Association (NYHA) Class III or IV congestive heart failure.

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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

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

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