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mTOR inhibitor
Sirolimus for Castleman Disease
Phase 2
Recruiting
Led By David C Fajgenbaum, MD, MBA, MS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to consume oral medication in the form of a tablet
Evidence of active disease, defined as at least two abnormalities in the criteria comprising the CBR criteria, including at least one objective measurement (hemoglobin, weight loss, or lymph node size)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, and 12 months ± 2 weeks
Awards & highlights
Study Summary
This trial will study the effect of sirolimus on idiopathic multicentric Castleman disease, a rare disorder that can cause enlarged lymph nodes and other problems.
Who is the study for?
This trial is for people aged 2-80 with idiopathic multicentric Castleman disease who haven't responded well to anti-IL-6 therapy or can't tolerate it. Participants must have active disease, be able to take oral medication, and not be pregnant or nursing. They shouldn't have had sirolimus before, any recent other systemic therapies except corticosteroids, severe infections mimicking iMCD, certain cancers within the last year, serious psychiatric disorders affecting consent ability, or very poor health as defined by specific medical criteria.Check my eligibility
What is being tested?
The study tests the effect of Sirolimus on patients with idiopathic multicentric Castleman disease who haven’t seen improvement with standard treatments. It aims to understand how this drug impacts their condition.See study design
What are the potential side effects?
Sirolimus may cause side effects like mouth sores, diarrhea, nausea; increased risk of infection; abnormal blood test results indicating liver or kidney issues; and potentially lung problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take pills by mouth.
Select...
My condition shows active disease with at least two symptoms, including one measurable change.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 9, and 12 months ± 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, and 12 months ± 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Disease activity, as measured by the CHAP scale
Disease activity, as measured by the MCD-related Overall Symptom Score
Proportion of patients achieving a lymph node response, following the modified Cheson response criteria
+3 moreSide effects data
From 2008 Phase 4 trial • 293 Patients • NCT0011874229%
Diarrhoea
18%
Abdominal Pain
16%
Nausea
16%
Headache
16%
Fatigue
16%
Hepatitis C
14%
Vomiting
14%
Pyrexia
14%
Leukopenia
12%
Oedema Peripheral
11%
Insomnia
10%
Anaemia
10%
Hyperkalaemia
10%
Tremor
10%
Back Pain
10%
Hypertension
9%
Cough
9%
Pruritis
9%
Arthralgia
8%
Neutropenia
8%
Abdominal Pain Upper
8%
Dizziness
8%
Pain in Extremity
8%
Hepatic Enzyme Increased
7%
Dyspnoea
7%
Constipation
7%
Sinusitis
7%
Weight Decreased
6%
Blood Creatinine Increased
6%
Liver Function Test Abnormal
6%
White Blood Cell Count Decreased
5%
Jaundice
5%
Renal Failure
5%
Muscle Spasms
5%
Decreased Appetite
5%
Weight Increased
5%
Upper Respiratory Tract Infection
5%
Nasopharyngitis
5%
Asthenia
5%
Incision Site Pain
5%
Depression
4%
Anorexia
4%
Night Sweats
4%
Oropharyngeal Pain
4%
Rhinorrhoea
3%
Myalgia
3%
Pleural Effusion
3%
Hyperlipidaemia
3%
Thrombocytopenia
3%
Rash
3%
Acne
3%
Incisional Hernia
2%
Sepsis
2%
Pneumonia
2%
Hypokalaemia
1%
Cerebral Haemorrhage
1%
Gastritis
1%
Urinary Retention
1%
Abdominal Hernia
1%
Multi-Organ Failure
1%
Ventricular Tachycardia
1%
Renal Failure Acute
1%
Hypoglycaemia
1%
Benign Prostatic Hyperplasia
1%
Non-Small Cell Lung Cancer Metastatic
1%
Crohn's Disease
1%
Clostridium Difficile Colitis
1%
Hepatic Neoplasm Malignant
1%
Hepatic Failure
1%
Chest Pain
1%
Blood Alkaline Phosphatase Increased
1%
Inappropriate Antidiuretic Hormone Secretion
1%
Gastrointestinal Haemorrhage
1%
Cardiac Failure Congestive
1%
Hepatic Artery Stenosis
1%
Portal Vein Thrombosis
1%
Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%
Gastrointestinal Tract Adenoma
1%
Febrile Neutropenia
1%
Encephalopathy
1%
Atrial Flutter
1%
Blood Glucose Increased
1%
Transplant Rejection
1%
Confusional State
1%
Spinal Osteoarthritis
1%
Hypercholesterolaemia
1%
Convulsion
1%
Peritonitis
1%
Haemorrhage Intracranial
1%
Deep Vein Thrombosis
1%
Inguinal Hernia
1%
Viral Infection
1%
Acarodermatitis
1%
Atrial Fibrillation
1%
Malaise
1%
Hepatic Cancer Metastatic
1%
Adenocarcinoma
1%
B-Cell Lymphoma
1%
Desmoid Tumour
1%
Pulmonary Embolism
1%
Stomatitis
1%
Influenza
1%
Staphylococcal Infection
1%
Umbilical Hernia
1%
Hepatic Function Abnormal
1%
Hyponatraemia
1%
Bacteraemia
1%
Cellulitis
1%
Clostridial Infection
1%
Diverticulitis
1%
Escherichia Urinary Tract Infection
1%
Lactobacillus Infection
1%
Lobar Pneumonia
1%
Pseudomonal Sepsis
1%
Post Procedural Haemorrhage
1%
Procedural Pain
1%
Biliary Anastomosis Complication
1%
Complications of Transplanted Kidney
1%
Bile Duct Obstruction
1%
Bile Duct Stenosis
1%
Biliary Tract Disorder
1%
Autoimmune Hepatitis
1%
Cholestasis
1%
Lung Disorder
1%
Pulmonary Oedema
1%
Sinus Congestion
1%
Embolism Venous
1%
Orthostatic Hypotension
1%
Vasculitis
1%
Hyperglycaemia
1%
Graft Versus Host Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept + Sirolimus
Trial Design
1Treatment groups
Experimental Treatment
Group I: SirolimusExperimental Treatment1 Intervention
Oral sirolimus: For adults, loading dose of 5 mg/m^2, rounded to the nearest mg, on day 1. For adults, starting on day 2, oral sirolimus daily at 2.5 mg/m^2/day (rounded to the nearest mg), target trough level 10-15 ng/mL by HPLC, for 12 months. For children, 2 mg/m^2/day, target trough level 5-15 ng/mL by HPLC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,209 Total Patients Enrolled
2 Trials studying Castleman Disease
1,130 Patients Enrolled for Castleman Disease
David C Fajgenbaum, MD, MBA, MSPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, HHV-8, or severe combined immunodeficiency syndrome.My condition did not improve with anti-IL-6 therapy, or I couldn't tolerate it.You have a medical history that matches the criteria for a specific disease called iMCD (idiopathic multicentric Castleman disease).I am not currently in, nor planning to join, another clinical trial for my condition.I can take pills by mouth.I am between the ages of 2 and 80.I do not have any uncontrolled infections that could be confused with iMCD.My condition shows active disease with at least two symptoms, including one measurable change.You have had an allergic reaction or sensitivity to sirolimus or similar medications in the past.I haven't had any treatment for iMCD, except possibly anti-IL6 therapy over 14 days ago.I have never been treated with sirolimus for my Castleman disease.I have never had a liver or lung transplant.I do not have any rheumatic diseases that could be confused with iMCD.I have no cancer history, except for certain skin cancers, cervical cancer in situ, or any cancer I haven't been treated for in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Sirolimus
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.
How many participants are being enrolled for this clinical experiment?
"The trial calls for 24 eligible patients to partake in the research, with recruiting sites including University of Arkansas for Medical Sciences situated in Little Rock and Children's Hospital of Philadelphia based in La Jolla."
Answered by AI
Has Sirolimus been previously tested in different clinical trials?
"Presently, 125 investigations are ongoing into the therapeutic effects of Sirolimus. Of those active studies, 13 have reached Phase 3 trials. Although most research is based in Cincinnati, Ohio, this treatment is being trialed across 1,074 sites globally."
Answered by AI
Am I eligible to contribute as a subject in this research trial?
"This trial is currently enrolling 24 people with Castleman Disease ranging in age from 2 to 80. Aspirants ought to be of any gender, have an established medical history that satisfies the diagnostic criteria for iMCD, not responded sufficiently to anti-IL-6 therapy or are intolerant/relapsed while on it, capable of ingesting oral tablets, and can provide informed consent or have a legally authorized representative do so on their behalf. In addition, they need evidence of active disease through two abnormal physiological signs as per Cheson Criteria - one being enlarged/evaluable lymph nodes."
Answered by AI
Is this investigation enrolling participants?
"Clinicaltrials.gov shows that this clinical trial is actively recruiting participants - it was first published on the 25th of September 2019 and its information was last refreshed on the 15th of April 2022."
Answered by AI
What medical conditions are commonly treated with Sirolimus?
"Rejection of transplant organs, liver ailments, diseases and kidney issues can be remedied through Sirolimus."
Answered by AI
To what extent could Sirolimus present a danger for those undergoing treatment?
"The safety rating of Sirolimus is assessed as a 2, indicating that there is some empirical evidence supporting its security but none demonstrating effectiveness."
Answered by AI
Are individuals over the age of forty eligible to join this investigation?
"To be accepted into this medical trial, the applicant must range between 2 to 80 years old. There are 57 studies for minors and 105 for seniors."
Answered by AI
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