New drug cocktail may tame deadly transplant complication
NCT ID NCT05621759
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new combination of three drugs (cyclophosphamide, abatacept, and tacrolimus) given at lower doses to prevent graft-versus-host disease (GVHD) in 27 adults receiving a stem cell transplant from a half-matched donor. GVHD is a serious condition where donor cells attack the patient's body. The goal is to see if this approach reduces GVHD while causing fewer side effects. Participants will be followed for up to two years after transplant.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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27 people
The number who actually took part.
- Started
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Sep 2022
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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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: * Age ≥ 18 years * Karnofsky score ≥ 70% * No evidence of progressive bacterial, viral, or fungal infection * Creatinine clearance \> 50 mL/min/1.72m2 * Total bilirubin, Alanine Aminotransferase and Aspartate Aminotransferase \< 2 x the upper limit of normal (except for diagnosed 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) for women of childbearing age and potential. Exclusion Criteria: * Donors are excluded in case of donor-specific HLA antibodies or positive cross-match. * Pregnant or nursing females or women of child bearing age or potential, who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from the first dose of conditioning regimen through day +180. 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. * 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
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NYU Langone Health
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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