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Disease-modifying antirheumatic drug (DMARD)
Leflunomide for COVID-19 in Cancer Patients
Phase 1 & 2
Waitlist Available
Led By Sanjeet S Dadwal
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recovery to =< grade 1 or to baseline for adverse events related to prior cancer therapy
Agreement by females and males of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study until teriflunomide levels are verified to be less than 0.02 mg/L (0.02 ug/mL) for patients given leflunomide, or until unblinding occurs for those given placebo
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
Study Summary
This trial is testing a drug called leflunomide to see if it's effective and safe in treating patients with COVID-19 who have had or currently have cancer.
Who is the study for?
This trial is for patients with severe COVID-19 who also have a history of cancer but haven't needed systemic cancer treatment in the last 2 years. They must be able to pause any current cancer treatments and meet certain health criteria like blood counts and liver function. Participants need confirmed COVID-19 via PCR test, agree to birth control measures, and can't have multi-organ failure or uncontrolled infections.Check my eligibility
What is being tested?
The study is testing Leflunomide's safety and effectiveness against COVID-19 in patients with past or present cancers. It compares Leflunomide with a placebo while following best practice care standards. The goal is to see if it can reduce the virus's ability to replicate by inhibiting RNA formation.See study design
What are the potential side effects?
Potential side effects of Leflunomide may include diarrhea, respiratory infection, hair loss, rash, high blood pressure, nausea, headache, bronchitis, abdominal pain; however specific side effects related to this patient group will be studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous cancer treatments have mostly gone away.
Select...
I agree to use birth control or not have heterosexual sex during the study.
Select...
My COVID-19 symptoms are severe, as per FDA guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical activity (Response)(Phase 2)
Incidence of toxicity, graded according to the NCI CTCAE version 5
Maximum tolerated dose (MTD) (Phase 1)
Secondary outcome measures
Hospitalization
Mechanical Ventilation duration
Mechanical Ventilation required
+6 moreOther outcome measures
Viral load
Side effects data
From 2015 Phase 4 trial • 400 Patients • NCT0117263933%
Upper respiratory tract infection
26%
Abdominal pain
23%
Nausea
19%
Gastroenteritis
16%
Hairloss
14%
Liver function disturbance
12%
Tendinopathy
12%
Arthralgia
9%
Vertigo
9%
Hypertension
9%
Eczema
7%
Increased transpiration
7%
Arthrosis
7%
Back pain
7%
Agitation
7%
Tooth extraction
7%
Paresthesia
7%
Pruritus
5%
Anaemia
5%
Venous insufficiency
5%
Palpitations
5%
Sjogren's disease
5%
Muscle cramps
5%
Influenza infection
5%
Fatigue
5%
Headache
5%
Bronchitis
5%
General malaise
5%
Arthritis
5%
Flushes
2%
Intervertebral disc disorder
2%
Pyrosis
2%
Endometrioid adenocarcinoma
2%
Rotator cuff lesion
2%
Bladder infection
2%
Eye infection
2%
Insomnia
2%
Diarrhoea
2%
Angina
2%
Kidney cancer malignant
2%
Pneumonia
2%
Cough
2%
Genital infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
CoBRA Slim Low Risk Group
Tight Step Up Low Risk Group
CoBRA Classic High Risk Group
CoBRA Slim High Risk Group
CoBRA Avant-garde High Risk Group
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase II Arm I (leflunomide, SOC)Experimental Treatment3 Interventions
Patients receive leflunomide PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Group II: Phase I (leflunomide, SOC)Experimental Treatment2 Interventions
Patients receive leflunomide PO QD on days 1-14. Patients may receive SOC drugs in addition to leflunomide.
Group III: Phase II Arm II (placebo, SOC)Placebo Group2 Interventions
Patients receive placebo PO QD on days 1-14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive SOC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Administration
2018
Completed Phase 3
~2540
Leflunomide
2003
Completed Phase 4
~1670
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,458 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,151 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Sanjeet S DadwalPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on steroids, new immune-suppressing drugs, certain enzyme affecting drugs, vitamin K blockers, or live vaccines.You have tested positive for COVID-19 with a PCR test within the last 4 days before joining the study.I can pause my cancer treatment for about 39 days.I have been diagnosed with severe lung problems or shock.I do not have HIV with low CD4+ T cell count, active tuberculosis, liver cancer spread, GI cancer causing malabsorption, or issues taking cholestyramine.I have an ongoing infection that is not under control.My side effects from previous cancer treatments have mostly gone away.I have multiple organ problems or liver disease.I agree to use birth control or not have heterosexual sex during the study.My COVID-19 symptoms are severe, as per FDA guidelines.Your blood cell count, liver function, and kidney function need to be within certain levels.I have given my informed consent, or my legal representative has.I haven't needed treatment for any cancer in the last 2 years.You have had allergic reactions to similar medicines before.I have a slow-growing cancer or a condition that could turn into cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I (leflunomide, SOC)
- Group 2: Phase II Arm I (leflunomide, SOC)
- Group 3: Phase II Arm II (placebo, SOC)
Awards:
This trial has 0 awards, including: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.
How many patients will be included in this research project?
"Yes, according to the information available on clinicaltrials.gov, this study is looking for volunteers right now. The listing was first posted on January 7th, 2021 and updated as recently as May 10th of this year. They need 30 people total at a single location."
Answered by AI
Are there any current openings for volunteers in this research program?
"Yes, the information on clinicaltrials.gov indicates that this trial is still recruiting patients. The original posting was on 1/7/2021, and the most recent update was on 5/10/2022. The study is looking for 30 patients at 1 site."
Answered by AI
What are the main goals of this clinical trial?
"The purpose of this 28-day study is to observe and document the toxicity levels of the experimental medication. Additionally, secondary outcomes such as improvement in oxygen saturation and length of time required for mechanical ventilation will be measured."
Answered by AI
What does the current research say about Leflunomide's efficacy?
"At the moment, there are a total of 16 ongoing clinical trials investigating leflunomide. Out of these active studies, 2 have progressed to Phase 3 testing. Although the majority of these trials are based in Duarte, California - 29 locations across the country are running similar research."
Answered by AI
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