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Prevention study for Acute Leukemia
Official title Trial of 2 Step ATG for Prevention of Acute GVHD Post Allogeneic Stem Cell Transplant
ClinicalTrials.gov ID: NCT06265584
What this study is testing
What is ATG dosing platform when combined with standard tacrolimus and mini methotrexate?
ATG dosing platform when combined with standard tacrolimus and mini methotrexate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute leukemia.
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
- In an effort to reduce graft versus host disease (GVHD) and enhance graft versus leukemia (GVL) effect post allogenic hematopoietic stem cell transplantation (AHSCT), recent research has focused on host immune cell depletion. Frame shifting anti-thymocyte globulin (ATG) backwards to earlier days before days 0 can result in deeper host and less graft T-cell depletion, leading to better immune reconstitution.
- 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 to 75
You may be able to join if
- Adult male or female, age 18-75 years
- Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or...
- A candidate for reduced intensity preparative regimen, based on age≥60, or HCT-CI of ≥4, or considered by the treating physician to have high risk...
- Cardiac function: Ejection fraction \>40%
- Measured creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)
You likely can't join if
- Autologous hematopoietic stem cell transplant \< 3 months prior to enrollment.
- Patients with florid residual AML with \> 5% blast in the marrow or circulating blast in the peripheral blood are not eligible for this study.
- Previous allogeneic stem cell transplant.
- Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.
- Known hypersensitivity to one or more of the study agents
- Received any investigational drugs within the 14 days prior to the first day of transplant conditioning
See the full eligibility criteria
- Adult male or female, age 18-75 years
- Patients must have a related or unrelated peripheral blood stem cell donor. Sibling donor must be a 6/6 match for HLA-A and -B at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing...
- A candidate for reduced intensity preparative regimen, based on age≥60, or HCT-CI of ≥4, or considered by the treating physician to have high risk for toxicity with myeloablative preparative regimen.
- Cardiac function: Ejection fraction \>40%
- Measured creatinine clearance greater than 50 mL/minute (using the Cockcroft-Gault formula and actual body weight)
- Pulmonary function: DLCO ≥50% (adjusted for hemoglobin) and FEV1≥50%
- Liver function: total bilirubin \< 1.5x the upper limit of normal and ALT/AST \< 2.5x the upper normal limit. Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of...
- Female people (unless postmenopausal for at least 1 year before the screening visit, or surgically sterilized), agree to practice two effective methods of contraception or agree to complete abstain from heterosexual...
- Male people (even if surgically sterilized), of partners of women of childbearing potential must agree to practice effective barrier contraception or abstain from heterosexual intercourse from the time of signing the...
- Karnofsky performance status KPS ≥ 70
- Patients must have a diagnosis of one of the following: A-AML with either detectable AML on pre AHSCT bone marrow (microscopic ≤5, flow or cytogenetic), or adverse cytogenetic, or molecular features (≥ 4 clonal...
- The subject is willing and able to signed informed consent and abide by the protocol requirements.
- Autologous hematopoietic stem cell transplant \< 3 months prior to enrollment.
- Patients with florid residual AML with \> 5% blast in the marrow or circulating blast in the peripheral blood are not eligible for this study.
- Previous allogeneic stem cell transplant.
- Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or EKG suggestive of acute ischemia or active conduction system abnormalities.
- Known hypersensitivity to one or more of the study agents
- Received any investigational drugs within the 14 days prior to the first day of transplant conditioning
- Pregnant and/or breastfeeding
- Evidence of HIV infection or known HIV positive serology.
- Current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
- Patient with documented cirrhosis
- Non-hematologic malignancy within prior three (3) years, with the exception of squamous cell or basal cell skin carcinoma. Patients with prior malignancies except resected localized non-melanoma skin cancer or treated...
- Participation in another clinical study with an investigational product during the last 28 days.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, 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.