International Registry for Patients With Castleman Disease

Castleman Disease Clinical Trial

— ACCELERATE  

Official title:

ACCELERATE (Advancing Castleman Care With an Electronic Longitudinal Registry, E-Repository, And Treatment/Effectiveness Research): An International Registry for Patients With Castleman Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817997
• Other study ID #: 10055241
• Secondary ID: 824758
• Status: Recruiting
• Start date: October 2016
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: David C Fajgenbaum, MD, MBA, MSc
• Phone: 215-614-0936
• Email: davidfa[@]mail.med.upenn.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to collect clinical, laboratory, and patient survey data from patients with Castleman disease to improve understanding, diagnosis, and treatment of the disease.

Description:

This project is supported by the Castleman Disease Collaborative Network.

Visit the CDCN website at http://www.cdcn.org/accelerate to sign up for the ACCELERATE registry!

The ACCELERATE patient registry will give patients and families the opportunity to contribute their medical data to improve understanding of Castleman Disease. The patient registry will obtain real-world demographic, clinical, laboratory, and patient reported outcomes, and treatment data from 1000 patients worldwide with Castleman Disease.

This registry will help to provide important data for future Castleman Disease research studies. The patient registry helps centralize information on this rare disease, and provides researchers a way to obtain data on Castleman Disease patients. The major objectives for the registry include:

1. Improve our understanding of the natural history (signs, symptoms, laboratory values, survival data, outcome predictors), pathogenesis, and treatment of Castleman disease by collecting a standardized set of demographic and longitudinal data from CD patients,

2. Build capacity for collaboration between patients, providers, researchers, and industry by collecting clinical data and tracking the location of all available tissue samples for future studies ("virtual biorepository"), and

3. Assemble "real-world" data related to burden of disease, treatments used, tolerability, and safety data.

Individuals affected by Castleman Disease and families of deceased patients are invited to join the registry. The patient registry will have two methods of entry.

Patients located anywhere in the United States of America (USA), Canada, or rest of world will be able to enroll themselves directly into the registry. Participants will enroll online and be asked to provide their electronic medical records to University of Pennsylvania researchers for data extraction. All patients in both groups will also be asked to complete questionnaires every three months about their symptoms, treatments, and experiences with Castleman Disease. Complete participant information will be stored in a secure database.

Researchers who are interested in studying Castleman Disease can also request access to registry datasets.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Person of any age

• Have a reference pathology report suggesting "Castleman disease" not limited to cutaneous involvement only that can be uploaded

• Be able to provide electronic informed consent, as per local regulations

• Deceased patients may also be enrolled when a reference pathology report suggesting "Castleman disease" can be supplied or when the ART is able to locate and upload such a pathology report.

Exclusion Criteria:

• Because this registry is designed to provide as wide a picture of routine clinical practice as possible, inclusion criteria are set deliberately wide and there are no exclusion criteria.

Related Conditions & MeSH terms

• Angiofollicular Lymph Hyperplasia
• Angiofollicular Lymph Node Hyperplasia
• Angiofollicular Lymphoid Hyperplasia
• Castleman Disease
• Castleman's Disease
• Giant Lymph Node Hyperplasia
• GLNH
• Hyperplasia
• Hyperplasia, Giant Lymph Node
• Lymph Node Hyperplasia, Giant
• Lymphadenopathy

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Castleman Disease Collaborative Network, EUSA Pharma, Inc., Food and Drug Administration (FDA)

Country where clinical trial is conducted

United States, 

References & Publications (18)

Arenas DJ, Floess K, Kobrin D, Pai RL, Srkalovic MB, Tamakloe MA, Rasheed R, Ziglar J, Khor J, Parente SAT, Pierson SK, Martinez D, Wertheim GB, Kambayashi T, Baur J, Teachey DT, Fajgenbaum DC. Increased mTOR activation in idiopathic multicentric Castlema — View Citation

Belyaeva E, Rubenstein A, Pierson SK, Dalldorf D, Frank D, Lim MS, Fajgenbaum DC. Bone marrow findings of idiopathic Multicentric Castleman disease: A histopathologic analysis and systematic literature review. Hematol Oncol. 2022 Apr;40(2):191-201. doi: 1 — View Citation

Fajgenbaum DC, Langan RA, Japp AS, Partridge HL, Pierson SK, Singh A, Arenas DJ, Ruth JR, Nabel CS, Stone K, Okumura M, Schwarer A, Jose FF, Hamerschlak N, Wertheim GB, Jordan MB, Cohen AD, Krymskaya V, Rubenstein A, Betts MR, Kambayashi T, van Rhee F, Ul — View Citation

Fajgenbaum DC, Pierson SK, Kanhai K, Bagg A, Alapat D, Lim MS, Lechowicz MJ, Srkalovic G, Uldrick TS, van Rhee F; ACCELERATE Registry Team. The disease course of Castleman disease patients with fatal outcomes in the ACCELERATE registry. Br J Haematol. 202 — View Citation

Fajgenbaum DC, van Rhee F, Nabel CS. HHV-8-negative, idiopathic multicentric Castleman disease: novel insights into biology, pathogenesis, and therapy. Blood. 2014 May 8;123(19):2924-33. doi: 10.1182/blood-2013-12-545087. Epub 2014 Mar 12. — View Citation

Koa B, Borja AJ, Aly M, Padmanabhan S, Tran J, Zhang V, Rojulpote C, Pierson SK, Tamakloe MA, Khor JS, Werner TJ, Fajgenbaum DC, Alavi A, Revheim ME. Emerging role of 18F-FDG PET/CT in Castleman disease: a review. Insights Imaging. 2021 Mar 11;12(1):35. d — View Citation

Liu AY, Nabel CS, Finkelman BS, Ruth JR, Kurzrock R, van Rhee F, Krymskaya VP, Kelleher D, Rubenstein AH, Fajgenbaum DC. Idiopathic multicentric Castleman's disease: a systematic literature review. Lancet Haematol. 2016 Apr;3(4):e163-75. doi: 10.1016/S2352-3026(16)00006-5. Epub 2016 Mar 17. — View Citation

Mango NA, Pierson SK, Sarmiento Bustamante M, Brandstadter JD, van Rhee F, Fajgenbaum DC. Siltuximab administration results in spurious IL-6 elevation in peripheral blood. Am J Hematol. 2024 Jan;99(1):E15-E18. doi: 10.1002/ajh.27132. Epub 2023 Oct 23. No — View Citation

Nishimura Y, Fajgenbaum DC, Pierson SK, Iwaki N, Nishikori A, Kawano M, Nakamura N, Izutsu K, Takeuchi K, Nishimura MF, Maeda Y, Otsuka F, Yoshizaki K, Oksenhendler E, van Rhee F, Sato Y. Validated international definition of the thrombocytopenia, anasarc — View Citation

Pai RL, Japp AS, Gonzalez M, Rasheed RF, Okumura M, Arenas D, Pierson SK, Powers V, Layman AAK, Kao C, Hakonarson H, van Rhee F, Betts MR, Kambayashi T, Fajgenbaum DC. Type I IFN response associated with mTOR activation in the TAFRO subtype of idiopathic — View Citation

Phillips AD, Kakkis JJ, Tsao PY, Pierson SK, Fajgenbaum DC. Increased mTORC2 pathway activation in lymph nodes of iMCD-TAFRO. J Cell Mol Med. 2022 Jun;26(11):3147-3152. doi: 10.1111/jcmm.17251. Epub 2022 Apr 30. — View Citation

Pierson SK, Katz L, Williams R, Mumau M, Gonzalez M, Guzman S, Rubenstein A, Oromendia AB, Beineke P, Fossa A, van Rhee F, Fajgenbaum DC. CXCL13 is a predictive biomarker in idiopathic multicentric Castleman disease. Nat Commun. 2022 Nov 24;13(1):7236. do — View Citation

Pierson SK, Khor JS, Ziglar J, Liu A, Floess K, NaPier E, Gorzewski AM, Tamakloe MA, Powers V, Akhter F, Haljasmaa E, Jayanthan R, Rubenstein A, Repasky M, Elenitoba-Johnson K, Ruth J, Jacobs B, Streetly M, Angenendt L, Patier JL, Ferrero S, Zinzani PL, T — View Citation

Pierson SK, Lim MS, Srkalovic G, Brandstadter JD, Sarmiento Bustamante M, Shyamsundar S, Mango N, Lavery C, Austin B, Alapat D, Lechowicz MJ, Bagg A, Li H, Casper C, van Rhee F, Fajgenbaum DC. Treatment consistent with idiopathic multicentric Castleman di — View Citation

Pierson SK, Shenoy S, Oromendia AB, Gorzewski AM, Langan Pai RA, Nabel CS, Ruth JR, Parente SAT, Arenas DJ, Guilfoyle M, Reddy M, Weinblatt M, Shadick N, Bower M, Pria AD, Masaki Y, Katz L, Mezey J, Beineke P, Lee D, Tendler C, Kambayashi T, Fossa A, van — View Citation

Pierson SK, Stonestrom AJ, Shilling D, Ruth J, Nabel CS, Singh A, Ren Y, Stone K, Li H, van Rhee F, Fajgenbaum DC. Plasma proteomics identifies a 'chemokine storm' in idiopathic multicentric Castleman disease. Am J Hematol. 2018 Jul;93(7):902-912. doi: 10 — View Citation

Sarmiento Bustamante M, Shyamsundar S, Coren FR, Bagg A, Srkalovic G, Alapat D, van Rhee F, Lim MS, Lechowicz MJ, Brandstadter JD, Pierson SK, Fajgenbaum DC. Ongoing symptoms following complete surgical excision in unicentric Castleman disease. Am J Hemat — View Citation

van Rhee F, Oksenhendler E, Srkalovic G, Voorhees P, Lim M, Dispenzieri A, Ide M, Parente S, Schey S, Streetly M, Wong R, Wu D, Maillard I, Brandstadter J, Munshi N, Bowne W, Elenitoba-Johnson KS, Fossa A, Lechowicz MJ, Chandrakasan S, Pierson SK, Greenwa — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Common Symptoms	There is no intervention tested in this registry. We want determine what are common symptoms are associated with Castleman Disease. We will be examining the number of instances various symptoms such as fatigue, malaise, fever are recorded in the medical records.	5 years
Primary	Common Laboratory Abnormalities	There is no intervention tested in this registry. We want determine what are common laboratory abnormalities associated with Castleman Disease. We will be examining the values of specific laboratory values associated with Castleman's Disease such as C-Reactive Protein (CRP), ferritin, and hemoglobin recorded in the medical records.	5 years
Primary	Treatment	There is no intervention tested in this registry. We want determine what are common treatments used for patients with Castleman Disease. We will be examining the number of instances specific treatments such as steroids and chemotherapy are recorded in the medical records.	5 years
Primary	Survival	There is no intervention tested in this registry. Distribution of time-to-event variables will be estimated using standard survival analysis methods, including Kaplan-Meier product-limit survival curves. The median time to event with 2-sided 95% confidence intervals will be estimated.	5 years
Primary	Identify patient subtypes	We will use data collected through this study to identify patient subgroups, particularly those that are not responsive to current treatments	4 years
Primary	Identify clinical outcome measures	We will use data collected through this study to determine the optimal parameters for overarching clinical outcome measures for use in future trials	4 years
Primary	Identify clinical biomarkers	We will use data collected through this study to identify biomarkers of treatment response	4 years

External Links

•   website includes information on Castleman Disease, the ACCELERATE Castleman Disease Registry, and related Castleman Disease links