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Compares treatment options for Hematopoietic and Lymphoid Cell Neoplasm
Official title Addition of Cord Blood Tissue-Derived Mesenchymal Stromal Cells to Ruxolitinib for the Treatment of Steroid-Refractory Acute Graft Versus Host Disease
ClinicalTrials.gov ID: NCT04744116
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hematopoietic and lymphoid cell neoplasm.
Also referred to as INCB-18424, INCB18424.
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 early phase I trial is to find out the effect of adding cord blood tissue-derived mesenchymal stromal cells (cb-MSCs) to ruxolitinib in treating patients with acute graft versus host disease that does not respond to steroid therapy (steroid-refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
- Phase 1: an early, usually small safety study
- Time commitment: about 6 months
- 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 12 to 80
You may be able to join if
- Participants between the ages of 12 years and 80 years (inclusive).
- Steroid refractory grades II-IV acute GVHD of the Lower GI tract or Liver (including those developing these manifestations after previous acute GVHD...
- Karnofsky/Lansky Performance score of at least 30 at the time of study entry.
- Participants who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must...
- Participants (or legal representative where appropriate) must be capable of providing written informed consent, and assent if indicated.
You likely can't join if
- De novo chronic GVHD
- Isolated acute GVHD of skin
- Secondary systemic therapy for acute GVHD ruxolitinib greater than 96 hours before initiation of therapy.
- Primary treatment with agents other than alpha-1 antitrypsin (AAT) glucocorticoids and ruxolitinib.
- Participants with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at...
- Adult and pediatric patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can...
See the full eligibility criteria
- Participants between the ages of 12 years and 80 years (inclusive).
- Steroid refractory grades II-IV acute GVHD of the Lower GI tract or Liver (including those developing these manifestations after previous acute GVHD of skin) secondary to allogeneic HCT or donor lymphocyte infusion...
- Karnofsky/Lansky Performance score of at least 30 at the time of study entry.
- Participants who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception
- Participants (or legal representative where appropriate) must be capable of providing written informed consent, and assent if indicated.
- De novo chronic GVHD
- Isolated acute GVHD of skin
- Secondary systemic therapy for acute GVHD ruxolitinib greater than 96 hours before initiation of therapy.
- Primary treatment with agents other than alpha-1 antitrypsin (AAT) glucocorticoids and ruxolitinib.
- Participants with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present...
- Adult and pediatric patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance...
- Participants with significant supplemental oxygen requirement defined as \>6 L oxygen by nasal cannula.
- Participants with known allergy to bovine or porcine products.
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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 80 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.