Spebrutinib (AVL-292) Clinical Trials

Size	Price	Qty
10mg	USD 297
50mg	USD 870

Clinical Trials

Multiple clinical trials have evaluated spebrutinib across Phase I and Phase II development, testing the drug as both monotherapy and combination therapy. Sponsored by entities including Celgene, The Lymphoma Academic Research Organisation, and The Leukemia and Lymphoma Society, these studies investigated indications such as diffuse large B-cell lymphoma, relapsed or refractory B-cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, active rheumatoid arthritis, and healthy volunteer cohorts. Recruitment status entries for these trials are listed as either completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02031419	TERMINATED	Lymphoma, Large B-Cell, Diffuse	Celgene	2013-12-18	PHASE1
NCT01732861	COMPLETED	Leukemia Lymphocytic Chronic B-Cell	Celgene	2012-12-28	PHASE1
NCT01975610	COMPLETED	Rheumatoid Arthritis	Celgene	2013-10	PHASE2
NCT01744626	COMPLETED	Leukemia Lymphocytic Chronic B-Cell	Celgene Corporation	2012-12	PHASE1
NCT01766583	COMPLETED	Relapsed/Refractory B-cell Lymphoma	The Lymphoma Academic Research Organisation	2013-02	PHASE1
NCT02433457	COMPLETED	Healthy Volunteers	Celgene	2014-05-26	PHASE1
NCT02031419	Terminated	Lymphoma Large B-Cell Diffuse	Celgene	2013-12-18	Phase 1
NCT01766583	Completed	Relapsed/Refractory B-cell Lymphoma	The Lymphoma Academic Research Organisation\|Celgene Corporation	2013-02	Phase 1
NCT01351935	Completed	B Cell Non-Hodgkin''s Lymphoma\|Chronic Lymphocytic Leukemia\|Waldenstrom Macroglobulinemia	Celgene\|The Leukemia and Lymphoma Society	2011-07-18	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-01-18)

Check the Spebrutinib (AVL-292) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Spebrutinib covalently binds to Bruton's tyrosine kinase with high selectivity, thereby inhibiting downstream signal transduction and suppressing B-cell proliferation and survival. This targeted pathway inhibition reduces oncogenic signaling and autoimmune activation, providing clinical relevance for treating B-cell malignancies, such as diffuse large B-cell lymphoma and chronic lymphocytic leukemia, as well as rheumatoid arthritis.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).