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Prevention study for Graft-versus-Host Disease (GVHD)
Official title Allogeneic HSCT With Low-Dose Post-Transplant Cyclophosphamide for GVHD Prevention
ClinicalTrials.gov ID: NCT06926595
What this study is testing
What is Cyclophosphamide (primary intervention for GVHD prophylaxis)?
Cyclophosphamide (primary intervention for GVHD prophylaxis) is an investigational medicine, being studied as a potential treatment for graft-versus-host disease (gvhd).
Also referred to as Tacrolimus (part of the GVHD prophylaxis regimen), Mycophenolate mofetil (MMF) (part of the GVHD prophylaxis regimen).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 2, single-arm, open-label study aims to evaluate the safety and efficacy of low-dose (25 mg/kg) post-transplant cyclophosphamide (PTCy) for prophylaxis of Graft-versus-Host Disease (GVHD) in patients undergoing allogeneic stem cell transplantation following reduced-intensity or non-myeloablative conditioning. The study will focus on matched sibling, matched unrelated, and haploidentical peripheral blood stem cell donors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 or older at the time of study enrollment.
- Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with...
- Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone...
- Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS/MPN...
- Patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who are indicated for allogeneic stem cell...
You likely can't join if
- Prior allogeneic stem cell transplant.
- Active central nervous system (CNS) involvement by malignant cells.
- Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).
- Seropositive for human immunodeficiency virus (HIV) with detectable viral load, hepatitis B virus (HBV) or hepatitis C virus (HCV) with detectable...
- Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled angina, severe...
- Pregnant or lactating female patients (unless feeding via formula). Women of childbearing potential (WOCBP) are required to have a negative serum or...
See the full eligibility criteria
- Age 18 or older at the time of study enrollment.
- Patients with acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia) or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow. Flow...
- Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia with no circulating blasts and less than 10% blasts in the bone marrow (exception allowed due to lack of difference in outcomes with \<5%...
- Patients with secondary acute myeloid leukemia progressing from pre-existing myelodysplastic syndrome, myeloproliferative disease (MPN), or MDS/MPN overlap syndrome.
- Patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma who are indicated for allogeneic stem cell transplantation.
- Patients with lymphoma who are indicated for allogeneic stem cell transplantation, including follicular lymphoma, Hodgkin lymphoma, diffuse large B cell lymphoma (including primary mediastinal B cell lymphoma), mantle...
- Planned reduced intensity or non-myeloablative conditioning regimen.
- Patients must have a related or unrelated peripheral blood stem cell donor as follows: Sibling donor must be at least haploidentical using high resolution DNA-based HLA typing. Children or parent donor must be at least...
- Cardiac function: must demonstrate at ejection fraction of at least 40%.
- Pulmonary function: must have FEV1 of at least 50% predicted, and DLCO corrected for hemoglobin of at least 40% predicted.
- Karnofsky performance status at least 70%.
- Women of childbearing potential (WOCP), defined as not surgically sterile (hysterectomy, tubal ligation, or oophorectomy) or at least 1 year postmenopausal, must have a negative serum pregnancy test before conditioning...
- Female patients (unless post-menopausal or surgically sterilized) must agree to practice two effective methods of contraception simultaneously or agree to completely abstain from heterosexual intercourse from the time...
- Male patients (even if surgically sterilized) who are partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing...
- Prior allogeneic stem cell transplant.
- Active central nervous system (CNS) involvement by malignant cells.
- Uncontrolled bacterial, viral, or fungal infections (currently taking medication with progression or no clinical improvement).
- Seropositive for human immunodeficiency virus (HIV) with detectable viral load, hepatitis B virus (HBV) or hepatitis C virus (HCV) with detectable viral load. Hepatitis B surface antibody positive due to vaccination or...
- Myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence...
- Pregnant or lactating female patients (unless feeding via formula). Women of childbearing potential (WOCBP) are required to have a negative serum or urine pregnancy test prior to conditioning regimen.
- Serious medical or psychiatric illness likely to interfere with participation in the study.
- Use of investigational agents.
- Haploidentical related recipient who are positive for DSA ≥ 5000 MFI by solid phase microarray method (Luminex).
- Any patient with steroid dose more than 10 mg/day within a week of registration.
- Autoimmune disorder requiring any active immunosuppression therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.