Immunosuppressant
Steroid Therapy for Graft-versus-Host Disease
City of Hope Medical Center, Duarte, CA
Targeting 2 different conditionsSteroid Therapy +2 morePhase 1RecruitingLed by Monzr M Al MalkiResearch Sponsored by City of Hope Medical CenterEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status >= 70
Note: HCT from any donor (related or unrelated with any degree of human leukocyte antigen [HLA] matching) and any graft source (bone marrow, peripheral blood stem cells, or cord blood) for hematologic malignancy or disorder. Recipient of myeloablative and reduced-intensity conditioning regimens are eligible
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 6 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a combination of drugs to treat patients with a specific kind of cancer. The drugs are designed to lower the body's immune response so that the new donor cells don't attack the body's normal cells.
Eligible Conditions
- Graft-versus-Host Disease
- Blood Cancers
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You are able to perform daily activities and take care of yourself with a score of 70 or higher on the Karnofsky performance scale.
Select...
You can receive a hematopoietic cell transplant (HCT) from any donor, whether they are related or unrelated to you and regardless of the level of matching with your HLA. The source of the transplant can be from bone marrow, peripheral blood stem cells, or cord blood. This criterion applies to people with hematologic malignancies or disorders who have undergone myeloablative or reduced-intensity conditioning regimens.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Failure-free survival (FFS)
Incidence of bloodstream infection severity
Sepsis
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment of aGVHD (steroid therapy, leflunomide)Experimental Treatment3 Interventions
Patients receive steroid therapy at the discretion of the treating physician. Beginning within 3 days of starting steroids, patients receive leflunomide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Patients who respond to leflunomide treatment will be tapered off from day 29 until day 56.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leflunomide
2003
Completed Phase 4
~1660
Cholestyramine
2018
Completed Phase 4
~320
Find a site
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,369 Previous Clinical Trials
41,215,247 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
City of Hope Medical CenterLead Sponsor
536 Previous Clinical Trials
2,250,882 Total Patients Enrolled
Monzr M Al MalkiPrincipal Investigator
City of Hope Medical Center5 Previous Clinical Trials
206 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrolment process currently active for this research?
"According to the information located on clinicaltrials.gov, this particular medical trial is not presently recruiting patients. This study was published December 10th 2022 and last edited June 30th 2022. While no longer enrolling participants at present, there are still 436 other studies open for recruitment right now."
Answered by AI
What potential risks accompany the use of Steroid Therapy?
"Based on our assessment, steroid therapy is considered to have a low level of safety given that this trial is only in the initial stages. Therefore we assign it a score of 1."
Answered by AI