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New drug combo aims to make bone marrow transplants safer

NCT ID NCT04395222

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether adding the drug tocilizumab to a standard transplant regimen can prevent graft failure and graft-versus-host disease in people with blood cancers receiving a special type of bone marrow transplant. The study involves 21 participants and aims to replace a stronger immune-suppressing drug to improve recovery and reduce relapse. Results will be tracked for up to 5 years.

What this could mean

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

Active substance
tocilizumab (also called Actemra)
What this could lead to
If successful, this could make haplo-cord transplants safer and more effective for people with blood cancers, reducing complications like graft failure and graft-versus-host disease.
What could go wrong
This is a small, early-phase trial with only 21 participants, so results may not apply broadly. The drug may not prevent graft failure or GVHD as hoped, and there are risks from the transplant itself.

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

21 people

The number who actually took part.

Started

Oct 2020

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: 1. Subject must have a confirmed diagnosis of one of the following: 1. Relapsed or refractory acute leukemia (myeloid or lymphoid) 2. Acute leukemia in first remission at high-risk for recurrence 3. Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis 4. Myelodysplastic syndromes 5. Chronic myeloproliferative disease 6. Recurrent, refractory or high-risk malignant lymphoma 7. Chronic lymphocytic leukemia, relapsed or with poor prognostic features 8. Multiple myeloma 9. Other hematological disorder in need of allogeneic transplant (e.g. blastoid dendritic cell neoplasm) 2. Age ≥ 18 years. 3. Likely to benefit from allogeneic transplant in the opinion of the transplant physician. 4. An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame. 5. Karnofsky Performance Status (KPS) of ≥ 70%. 6. Acceptable organ function as defined below: 1. Serum bilirubin: \<2.0 mg/dL 2. ALT (SGPT) \<3x upper limit of normal (ULN) 3. Creatinine Clearance: \>50 mL/min/1.73m2 (eGFR as estimated by the modified MDRD equation) 4. Left ventricular ejection fraction \>40% 5. Pulmonary diffusion capacity \>40% predicted 7. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Life expectancy is severely limited by concomitant illness or uncontrolled infection. 2. Evidence of chronic active hepatitis or cirrhosis 3. Uncontrolled HIV disease. 4. Pregnancy or lactation. 5. History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal perforation 6. History of allergic reactions attributed to compounds of similar chemical or biological composition as tocilizumab, including known allergies to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.

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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

  • Weill Cornell Medical College

    New York, New York, 10065, United States

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