New drug cocktail aims to stop transplant rejection
NCT ID NCT03945591
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested whether giving high doses of cyclophosphamide and bortezomib after a stem cell transplant could prevent graft-versus-host disease (GVHD), a serious complication where donor cells attack the patient's body. Twenty-three adults with blood cancers received the drug combination. The main goals were to see how many developed acute or chronic GVHD. The study is complete, but results are not yet reported.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cyclophosphamide and bortezomib
- What this could lead to
- If successful, this drug combination could become a standard way to prevent graft-versus-host disease after stem cell transplants, making the procedure safer.
- What could go wrong
- This is a small, early-phase trial with only 23 participants and no comparison group. The results may not apply to all patients, and the drugs can cause side effects like infections or organ damage.
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
-
23 people
The number who actually took part.
- Started
-
Jun 2019
- Finished
-
Jan 2024
- 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: * Karnofsky score ≥ 70% * No evidence of progressive bacterial, viral, or fungal infection * Creatinine clearance \> 50 mL/min/1.72m2 * Total bilirubin, ALT and AST \< 2 x the upper limit of normal (except for Gilbert's syndrome) * Alkaline phosphatase ≤ 250 IU/L * Left Ventricular Ejection Fraction (LVEF) \> 45% * Adjusted Carbon Monoxide Diffusing Capacity (DLCO) \> 60% * Negative HIV serology * Negative pregnancy test: confirmation per negative serum β-human chorionic gonadotropin (β-hCG) Exclusion Criteria: * Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from the first dose of bortezomib through 90 days after the last dose. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row. * Male subjects who refuse to practice effective barrier contraception during the entire study treatment period and through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy). * Inability to provide informed consent. * Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix E), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant. * Known allergies to any of the components of the investigational treatment regimen. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy. * Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. * Prisoners
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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
-
New York University School of Medicine
New York, New York, 10016, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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