CompletedPhase 2

Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation

United States43 participantsStarted 2019-11-26

Plain-language summary

The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from your donor (the graft) see your body's cells (the host) as different and attack them.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * High risk hematologic malignancy justifying the need for an allogeneic hematopoetic stem cell transplantation: AML, ALL, CML in accelerated or blast phase, MDS/MPN, NHL, Hodgkin lymphoma, and multiple myeloma * Creatinine clearance \> 40 * Adequate hepatic function * Normal cardiac function (EF \> 50%) Exclusion Criteria: * Patients with hematologic malignancies for which transplant is not the only curative option, such as AML with good or intermediate cytogenetics or molecular markers in CR1 or CML in chronic phase * Inability to identify an 10/10 HLA-Matched Donor (related or unrelated) or a haploidentical donor * Active malignant disease relapse * Active, uncontrolled infection, uncontrolled cardiac angina, symptomatic congestive heart failure * Life expectancy \<3 months * Pregnancy or lactation * Patients may not be receiving any other investigational agents in the last 28 days * Patients with chronic myeloid leukemia in first chronic phase

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of Moderate and Severe Chronic GVHD at One Year Post Transplant

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT03680092

SponsorDimitrios Tzachanis, MD PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-15

Results submitted2024-09-04

View on ClinicalTrials.gov More GVHD trials