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OncoMatch/Clinical Trials/NCT04744116

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

Is NCT04744116 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Ruxolitinib for hematopoietic and lymphoid cell neoplasm.

Early Phase 1RecruitingM.D. Anderson Cancer CenterNCT04744116Data as of May 2026

Treatment: RuxolitinibThis 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Disease stage

Required: Stage II, III, IV

Prior therapy

Must have received: systemic corticosteroid (methylprednisolone) — acute GVHD

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

Cannot have received: secondary systemic therapy for acute GVHD (ruxolitinib >96 hours before initiation of therapy) (ruxolitinib)

Secondary systemic therapy for acute GVHD ruxolitinib greater than 96 hours before initiation of therapy

Cannot have received: primary treatment with agents other than alpha-1 antitrypsin (AAT), glucocorticoids, and ruxolitinib

Primary treatment with agents other than alpha-1 antitrypsin (AAT) glucocorticoids and ruxolitinib

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

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