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New drug may make stem cell transplants safer for older patients

NCT ID NCT05823571

Disease control Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Updated 1 time

Summary

This early-phase trial tests whether the drug itacitinib can prevent cytokine release syndrome (a severe inflammatory reaction) after a mini stem cell transplant in people aged 60 and older with certain blood cancers. The study also aims to see if itacitinib allows doctors to use shorter courses of other immune-suppressing drugs. About 32 participants will receive itacitinib alongside standard transplant care to find the safest and most effective regimen.

What this could mean

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

Active substance
itacitinib
What this could lead to
If it works, this could lead to safer stem cell transplants with fewer complications and less need for long-term immune-suppressing drugs.
What could go wrong
This is a very early Phase 1 trial with only 32 participants, so it is primarily testing safety. It may not show clear benefits, and there are risks from the transplant and immune suppression.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

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

Started

Jul 2023

Expected to finish

Mar 2030

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

60 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: * Presence of a suitable related, HLA-haploidentical (partially mismatched) stem cell donor. * Eligible diagnoses: 1. Acute leukemias in complete remission with minimal residual disease 2. Myelodysplastic syndrome (MDS) with at least one poor-risk feature 3. Chronic myelomonocytic leukemia with at least one poor-risk feature 4. T-cell PLL in PR or better prior to transplantation. 5. Tyrosine kinase-refractory CML in first chronic phase, TKI-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase. 6. Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis) 7. Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen * Age ≥ 60 years. * Adequate end-organ function as measured by: 1. Left ventricular ejection fraction ≥ 35% or shortening fraction \> 25% 2. Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST ≤ 5 x ULN 3. FEV1 and FVC ≥ 40% of predicted * ECOG performance status ≤ 2 or Karnofsky score ≥ 60 Exclusion Criteria: * No active extramedullary leukemia or known active CNS involvement by malignancy. * Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning. * No previous allogeneic HSCT. * Not pregnant or breast-feeding * No uncontrolled infection. * No known HIV infection. * No active replicating HBV or HCV infection detected by PCR that requires treatment or at risk for HBV reactivation (positive HBsAg)

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Conditions

The condition(s) this trial relates to.

acute leukemia chronic myelogenous leukemia, BCR-ABL1 positive chronic myelomonocytic leukemia leukemia myelodysplastic syndrome Myelodysplastic Syndromes Myeloproliferative Disorders myeloproliferative neoplasm plasma cell leukemia plasma cell myeloma T-cell prolymphocytic leukemia

As listed by the trial registrant

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

CML Leukemia, acute Multiple myeloma Myelodysplastic syndromes Myelomonocytic leukemia, chronic Myeloproliferative disorders Plasma cell leukemia T-cell prolymphocytic leukemia

Contacts and locations

Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231, United States

More trials for these conditions

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