New drug combo aims to make bone marrow transplants safer
NCT ID NCT04395222
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 Hide 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can regional data improve bone marrow transplant results for blood cancers?
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