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Janus Kinase (JAK) Inhibitor
Cellular Therapy + Ruxolitinib for Graft-versus-Host Disease
Phase < 1
Recruiting
Led By Partow Kebriaei
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky/Lansky Performance score of at least 30 at the time of study entry
Patient (or legal representative where appropriate) must be capable of providing written informed consent, and assent if indicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights
Study Summary
This trial is testing whether adding cord blood-derived mesenchymal stromal cells to ruxolitinib can help treat patients with acute graft versus host disease that has not responded to steroid therapy.
Who is the study for?
This trial is for patients aged 12-80 with acute graft versus host disease that's not improving with steroids, specifically affecting the lower GI tract or liver. They must have a certain level of kidney function and be able to consent. Women who can get pregnant and men must use birth control. People with skin-only GVHD, uncontrolled infections, significant oxygen needs, allergies to certain animal products, or using other treatments are excluded.Check my eligibility
What is being tested?
The study tests adding cord blood tissue-derived mesenchymal stromal cells (cb-MSCs) to ruxolitinib in treating steroid-refractory acute graft versus host disease after stem cell transplant. It explores whether cb-MSCs combined with ruxolitinib can better manage the condition compared to standard treatments.See study design
What are the potential side effects?
Potential side effects include those related to ruxolitinib like anemia, low platelet count, dizziness and headache; plus risks from cellular therapy such as immune reactions or infection at injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
Select...
I can give my consent, or my legal representative can, for this trial.
Select...
I am between 12 and 80 years old.
Select...
My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).
Select...
I have severe GVHD in my lower GI or liver that didn't improve with high-dose steroids.
Select...
I am not pregnant or breastfeeding and use birth control. Or, I use birth control as a man.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Death from any cause
Incidence of adverse events
Response
Secondary outcome measures
Cumulative incidence of non-relapse mortality (NRM)
Cumulative incidence of relapse/progression of the primary disease
Disease-free survival
+16 moreOther outcome measures
Cytokine biomarker analysis (optional)
Fecal samples analysis (optional)
Side effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803623%
Pruritus
12%
Headache
9%
Diarrhoea
9%
Upper respiratory tract infection
8%
Fatigue
8%
Asthenia
8%
Thrombocytopenia
7%
Nausea
7%
Dizziness
7%
Night sweats
7%
Haematocrit increased
5%
Influenza
5%
Weight decreased
5%
Erythema
5%
Decreased appetite
5%
Leukocytosis
5%
Constipation
4%
Thrombocytosis
4%
Abdominal pain upper
4%
Arthralgia
4%
Hypertension
3%
Pain in extremity
3%
Oedema peripheral
3%
Dyspnoea
3%
Epistaxis
3%
Bronchitis
3%
Abdominal discomfort
3%
Tinnitus
3%
Nasopharyngitis
3%
Myalgia
3%
Dyspepsia
3%
Cough
1%
Anaemia
1%
Vertigo
1%
Depression
1%
Weight increased
1%
Haematoma
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Syncope
1%
Respiratory failure
1%
Abdominal pain
1%
Neutropenia
1%
Muscle spasms
1%
Rectal haemorrhage
1%
Cellulitis
1%
Meningitis
1%
Pneumonia
1%
Septic shock
1%
Hyponatraemia
1%
Acute myeloid leukaemia
1%
Bladder transitional cell carcinoma
1%
Breast cancer
1%
Myelofibrosis
1%
Extremity necrosis
1%
Abdominal distension
1%
Flatulence
1%
Vomiting
1%
Pyrexia
1%
Blood lactate dehydrogenase increased
1%
Gamma-glutamyltransferase increased
1%
Hyperuricaemia
1%
Musculoskeletal pain
1%
Osteoarthritis
1%
Cardiac failure
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Best Available Therapy
All Crossover Patients
Ruxolitinib
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3 (ruxolitinib, higher dose ds-MSCs)Experimental Treatment2 Interventions
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.
Group II: Arm 2 (ruxolitinib, lower dose ds-MSCs)Experimental Treatment2 Interventions
Patients receive ruxolitinib PO BID as in Arm 1. Patients also receive lower 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.
Group III: Arm 1 (ruxolitinib)Active Control1 Intervention
Patients receive ruxolitinib PO 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,959 Previous Clinical Trials
1,798,466 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,615 Previous Clinical Trials
40,918,596 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Partow KebriaeiPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may need occasional help.I can give my consent, or my legal representative can, for this trial.I am between 12 and 80 years old.I do not have any infections, or if I do, they are under control with no worsening signs.I have a skin condition caused by a recent transplant.My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).I have severe GVHD in my lower GI or liver that didn't improve with high-dose steroids.I am not pregnant or breastfeeding and use birth control. Or, I use birth control as a man.I have been diagnosed with new onset chronic graft-versus-host disease.I started treatment for acute GVHD with ruxolitinib more than 96 hours ago.My primary treatment did not include AAT, steroids, or ruxolitinib.I need more than 6 liters of oxygen through a nasal tube.You are allergic to products derived from cows or pigs.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (ruxolitinib)
- Group 2: Arm 2 (ruxolitinib, lower dose ds-MSCs)
- Group 3: Arm 3 (ruxolitinib, higher dose ds-MSCs)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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