NCT02817997

Brief 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. Funding source - FDA OOPD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2016Sep 2027

First Submitted

Initial submission to the registry

June 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

10.9 years

First QC Date

June 22, 2016

Last Update Submit

February 27, 2026

Conditions

Angiofollicular Lymph HyperplasiaAngiofollicular Lymph Node HyperplasiaAngiofollicular Lymphoid HyperplasiaHyperplasia, Giant Lymph NodeLymph Node Hyperplasia, GiantGiant Lymph Node HyperplasiaCastleman DiseaseCastleman's DiseaseGLNH

Keywords

patient registryACCELERATE studyCDMCDiMCDCastlemanCastleman's DiseaseAngiofollicular Lymph Hyperplasiamulticentric Castleman's diseasemulticentric Castleman disease

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Identify clinical biomarkers

    We will use data collected through this study to identify biomarkers of treatment response

    4 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Castleman Disease patients worldwide

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (22)

  • 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.

    PMID: 27063975BACKGROUND

  • 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.

    PMID: 24622327BACKGROUND

  • 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, Terriou L, Casper C, Jaffe E, Hoffmann C, Oksenhendler E, Fossa A, Srkalovic G, Chadburn A, Uldrick TS, Lim M, van Rhee F, Fajgenbaum DC. ACCELERATE: A Patient-Powered Natural History Study Design Enabling Clinical and Therapeutic Discoveries in a Rare Disorder. Cell Rep Med. 2020 Dec 22;1(9):100158. doi: 10.1016/j.xcrm.2020.100158. eCollection 2020 Dec 22.

    PMID: 33377129RESULT

  • 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: 10.1002/ajh.25123. Epub 2018 May 16.

    PMID: 29675946RESULT

  • 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, Uldrick TS. Identifying and targeting pathogenic PI3K/AKT/mTOR signaling in IL-6-blockade-refractory idiopathic multicentric Castleman disease. J Clin Invest. 2019 Aug 13;129(10):4451-4463. doi: 10.1172/JCI126091.

    PMID: 31408438RESULT

  • 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 Castleman disease. Blood. 2020 May 7;135(19):1673-1684. doi: 10.1182/blood.2019002792.

    PMID: 32206779RESULT

  • 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 multicentric Castleman disease. JCI Insight. 2020 May 7;5(9):e135031. doi: 10.1172/jci.insight.135031.

    PMID: 32376796RESULT

  • 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, Greenway A, Nasta S, Yoshizaki K, Kurzrock R, Uldrick TS, Casper C, Chadburn A, Fajgenbaum DC. International evidence-based consensus diagnostic and treatment guidelines for unicentric Castleman disease. Blood Adv. 2020 Dec 8;4(23):6039-6050. doi: 10.1182/bloodadvances.2020003334.

    PMID: 33284946RESULT

  • 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. doi: 10.1186/s13244-021-00963-1.

    PMID: 33709329RESULT

  • 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, anasarca, fever, reticulin fibrosis, renal insufficiency, and organomegaly clinical subtype (TAFRO) of idiopathic multicentric Castleman disease. Am J Hematol. 2021 Oct 1;96(10):1241-1252. doi: 10.1002/ajh.26292. Epub 2021 Jul 28.

    PMID: 34265103RESULT

  • 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 Rhee F, Fajgenbaum DC. Discovery and validation of a novel subgroup and therapeutic target in idiopathic multicentric Castleman disease. Blood Adv. 2021 Sep 14;5(17):3445-3456. doi: 10.1182/bloodadvances.2020004016.

    PMID: 34438448RESULT

  • 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: 10.1002/hon.2969. Epub 2022 Feb 18.

    PMID: 35104370RESULT

  • 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.

    PMID: 35488725RESULT

  • 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. 2022 Jul;198(2):307-316. doi: 10.1111/bjh.18214. Epub 2022 May 4.

    PMID: 35507638RESULT

  • 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. doi: 10.1038/s41467-022-34873-7.

    PMID: 36433996RESULT

  • 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 Hematol. 2023 Nov;98(11):E334-E337. doi: 10.1002/ajh.27065. Epub 2023 Aug 28. No abstract available.

    PMID: 37635628RESULT

  • 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 disease guidelines is associated with improved outcomes. Blood Adv. 2023 Nov 14;7(21):6652-6664. doi: 10.1182/bloodadvances.2023010745.

    PMID: 37656441RESULT

  • 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 abstract available.

    PMID: 37867418RESULT

  • Shyamsundar S, Pierson SK, Connolly CM, Teles M, Segev DL, Werbel WA, van Rhee F, Casper C, Brandstadter JD, Noy A, Fajgenbaum DC. Castleman disease patients report mild COVID-19 symptoms and mount a humoral response to SARS-CoV-2 vaccination. Blood Neoplasia. 2024 Mar;1(1):100002. doi: 10.1016/j.bneo.2024.100002. Epub 2024 Feb 15.

    PMID: 39044861DERIVED

  • Rubenstein AI, Pierson SK, Shyamsundar S, Bustamante MS, Gonzalez MV, Milller ID, Brandstadter JD, Mumau MD, Fajgenbaum DC. Immune-mediated thrombocytopenia and IL-6-mediated thrombocytosis observed in idiopathic multicentric Castleman disease. Br J Haematol. 2024 Mar;204(3):921-930. doi: 10.1111/bjh.19279. Epub 2024 Jan 2.

    PMID: 38168727DERIVED

  • Dispenzieri A, Fajgenbaum DC. Overview of Castleman disease. Blood. 2020 Apr 16;135(16):1353-1364. doi: 10.1182/blood.2019000931.

    PMID: 32106302DERIVED

  • van Rhee F, Voorhees P, Dispenzieri A, Fossa A, Srkalovic G, Ide M, Munshi N, Schey S, Streetly M, Pierson SK, Partridge HL, Mukherjee S, Shilling D, Stone K, Greenway A, Ruth J, Lechowicz MJ, Chandrakasan S, Jayanthan R, Jaffe ES, Leitch H, Pemmaraju N, Chadburn A, Lim MS, Elenitoba-Johnson KS, Krymskaya V, Goodman A, Hoffmann C, Zinzani PL, Ferrero S, Terriou L, Sato Y, Simpson D, Wong R, Rossi JF, Nasta S, Yoshizaki K, Kurzrock R, Uldrick TS, Casper C, Oksenhendler E, Fajgenbaum DC. International, evidence-based consensus treatment guidelines for idiopathic multicentric Castleman disease. Blood. 2018 Nov 15;132(20):2115-2124. doi: 10.1182/blood-2018-07-862334. Epub 2018 Sep 4.

    PMID: 30181172DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Lymph node and/or bone marrow slides and/or tissue blocks may be sent to research team at the University of Pennsylvania to be scanned and uploaded to assist with grading likelihood of accurate diagnosis, if allowed by local regulations. Patients will be given the option to consent for lymph node and bone marrow slides collected for the registry that are determined to be unnecessary for the registry to be used for research studies, such as genomic sequencing or immunohistochemistry.

MeSH Terms

Conditions

Castleman DiseaseMacular dystrophy, corneal type 1Multi-centric Castleman's Disease

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Joshua Brandstadter, MD, PhD, MSc

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Brandstadter, MD, PhD, MSc

CONTACT

267-847-8220joshua.brandstadter@pennmedicine.upenn.edu

Bridget Austin, MSc

CONTACT

2675869977accelerate@uphs.upenn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 29, 2016

Study Start

October 1, 2016

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Qualified Researchers, who apply for access to the database and are subsequently approved, will be given access to a limited dataset with direct identifiers removed in an Excel compatible file format or single SAS data files. The Certification \& Access Subcommittee will review applications from qualified researchers on an ongoing basis.

Locations

US(1)