Addition of Cord Blood Tissue-Derived Mesenchymal Stromal Cells to Ruxolitinib for the Treatment of Steroid-Refractory Acute Graft Versus Host Disease

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Janus Kinase Inhibitors

Criteria

Inclusion Criteria:

• Patients between the ages of 12 years and 80 years (inclusive)

• Steroid refractory grades II-IV acute GVHD of the lower gastrointestinal (GI) tract or liver (including those developing these manifestations after previous acute GVHD of skin) secondary to allogeneic hematopoietic cell transplantation (HCT) or donor lymphocyte infusion. 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 doses of systemic steroids of 0.5 mg/kg/day or greater. Patients must have had a biopsy that suggests GVHD; a repeat biopsy to enroll on the study is not necessary

• Estimated creatinine clearance >= 30 mL/min

• Karnofsky/Lansky performance score of at least 30 at the time of study entry

• Patients who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male patients must use adequate contraception

• Patient (or legal representative where appropriate) must be capable of providing written informed consent, and assent if indicated

Exclusion Criteria:

• 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 glucocorticoids and ruxolitinib

• Patients 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

• Patient with significant supplemental oxygen requirement defined as > 6 L oxygen by nasal cannula

• Patient with known allergy to bovine or porcine products