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Compares treatment options for AML
Official title A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
ClinicalTrials.gov ID: NCT06973668
What this study is testing
What is Mycophenolate Mofetil?
Mycophenolate Mofetil is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for aml.
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
- The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 75
You may be able to join if
- Age ≥ 65 and \< 75 years are eligible if they have one of the following diseases.
- Acute Myeloid Leukemia
- Myelodysplastic syndrome
- Chronic myelomonocytic leukemia
- Available HLA-identical or haploidentical related donor or a 7/8 or 8/8 HLA matched unrelated donor.
You likely can't join if
- Subject is known to be positive for HIV.
- Subject has acute promyelocytic leukemia.
- Subject has known active CNS involvement with AML.
- Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score of \>5
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
See the full eligibility criteria
- Age ≥ 65 and \< 75 years are eligible if they have one of the following diseases.
- Acute Myeloid Leukemia
- Myelodysplastic syndrome
- Chronic myelomonocytic leukemia
- Available HLA-identical or haploidentical related donor or a 7/8 or 8/8 HLA matched unrelated donor.
- Peripheral blood stem cells as a graft source
- Subject must voluntarily sign an informed consent.
- Adequate organ function per local laboratory reference range as follows: - Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0X ULN - Total Bilirubin \<1.5 x ULN (unless bilirubin rise is due to Gilbert's...
- DLCO corrected for Hgb, if applicable) ≥ 50% of predicted
- Ejection Fraction ≥ 50%
- The effects on the developing human fetus are unknown. For this reason and as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch...
- Subject is known to be positive for HIV.
- Subject has acute promyelocytic leukemia.
- Subject has known active CNS involvement with AML.
- Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score of \>5
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: people with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive...
- Cardiac history of CHF requiring treatment or Ejection Fraction \< 50% or unstable angina or MI within 1 year of study entry
- Major adverse cardiac events such as MI/stroke and pulmonary embolism (PE)/deep vein thrombosis (DVT) within 6 months. Recent history of Central line-associated DVT may be allowed after discussion with PI.
- Current and/or history of active TB
- White Blood Cell count \> 25 X 109 /L.
- Pregnant women are excluded from this study because the study agent has unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 65 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.