Multiple clinical trials in hematologic oncology are evaluating protocols associated with this compound, primarily targeting relapsed or refractory Hodgkin lymphoma and diffuse large B-cell lymphoma. Sponsored by healthcare institutions and cooperative groups, including the Fondazione Italiana Linfomi, Stichting Hemato-Oncologie voor Volwassenen Nederland, and the National Medical Surgical Center N.A. N.I. Pirogov, these Phase II and combined Phase I/II studies range in recruitment status from actively recruiting to completed or terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04091490 | Completed | Hodgkin Lymphoma |
State Budgetary Healthcare Institution National Medical Surgical Center N.A. N.I. Pirogov Ministry of Health of Russia |
2020-02-19 | Phase 2 |
| NCT03356054 | Recruiting | DLBCL |
Stichting Hemato-Oncologie voor Volwassenen Nederland |
2018-03-05 | Phase 1|Phase 2 |
| NCT02374424 | Terminated | Diffuse Large B-Cell Lymphoma |
Fondazione Italiana Linfomi - ETS |
2014-11-05 | Phase 2 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
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>).
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