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

  • STATUS
    Recruiting
  • days left to enroll
    4
  • participants needed
    24
  • sponsor
    M.D. Anderson Cancer Center
Updated on 24 November 2021
cancer
graft versus host disease
cell transplantation
acute graft versus host disease
donor lymphocyte infusion

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.

Description

PRIMARY OBJECTIVE:

I. To estimate between-arm differences (Arm 3 versus [vs] Arm 1, and Arm 2 vs Arm 1) for each of the 28-day co-primary outcome probabilities.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM 1: Patients receive ruxolitinib orally (PO) twice daily (BID) for at least 3 days and may consider tapering after 6 months of therapy if response occurs and therapeutic corticosteroid doses have been discontinued.

ARM 2: Patients receive ruxolitinib PO BID as in Arm 1. Patients also receive lower dose of cb-MSCs intravenously (IV) for up to 60 minutes twice weekly (at least 3 days apart) over 4 consecutive weeks for 8 total doses.

ARM 3: Patients receive ruxolitinib PO BID as in Arm 1. Patients also receive higher dose of cb-MSCs IV for up to 60 minutes twice weekly (at least 3 days apart) over 4 consecutive weeks for 8 total doses.

After completion of study treatment, patients are followed up on day 28 and then for up to 6 months.

Details
Condition Hematologic Malignancy, Steroid Refractory Graft Versus Host Disease, hematopoietic and lymphoid cell neoplasm, steroid refractory cgvhd, hematopoietic malignancy
Treatment Ruxolitinib, Cellular Therapy
Clinical Study IdentifierNCT04744116
SponsorM.D. Anderson Cancer Center
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

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
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