NCT04744116 Addition of Cord Blood Tissue-Derived Mesenchymal Stromal Cells to Ruxolitinib for the Treatment of Steroid-Refractory Acute Graft Versus Host Disease
| NCT ID | NCT04744116 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Hematopoietic and Lymphoid Cell Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-02-17 |
| Primary Completion | 2032-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2021-02-17 with a primary completion date of 2032-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. cb-MSCs are a type of tissue helper cell that can be removed from donated umbilical cord blood tissue and grown into many different cell types that can be used to treat cancer and other disease, such as graft versus host disease. This trial aims to learn if adding cb-MSCs to ruxolitinib may help control steroid-refractory acute graft versus host disease.
Eligibility Criteria
Inclusion Criteria: 1. Participants between the ages of 12 years and 80 years (inclusive). 2. 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. (Grading, see Appendix I) GVHD with: No improvement after treatment with methylprednisolone at ≥ 2.0 mg/kg/day or equivalent for minimum 7 days, or progressive symptoms after minimum 3 days, or a flare in acute GVHD while on systemic steroids. Participants must have had a biopsy that suggests GVHD; a repeat biopsy to enroll on the study is not necessary. 3. Karnofsky/Lansky Performance score of at least 30 at the time of study entry. 4. Participants who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception 5. Participants (or legal representative where appropriate) must be capable of providing written informed consent, and assent if indicated. Exclusion Criteria: 1. De novo chronic GVHD 2. Isolated acute GVHD of skin 3. Secondary systemic therapy for acute GVHD ruxolitinib greater than 96 hours before initiation of therapy. 4. Primary treatment with agents other than alpha-1 antitrypsin (AAT) glucocorticoids and ruxolitinib. 5. 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. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 6. 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 with study procedures. 7. Participants with significant supplemental oxygen requirement defined as \>6 L oxygen by nasal cannula. 8. Participants with known allergy to bovine or porcine products.
Contact & Investigator
Partow Kebriaei, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04744116 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 80 Years, studying Hematopoietic and Lymphoid Cell Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04744116 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04744116 currently recruiting?
Yes, NCT04744116 is actively recruiting participants. Contact the research team at pkebriae@mdanderson.org for enrollment information.
Where is the NCT04744116 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04744116 clinical trial?
NCT04744116 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Partow Kebriaei, MD at M.D. Anderson Cancer Center. The trial plans to enroll 24 participants.