Multiple clinical trials evaluate harringtonine and homoharringtonine across early to late phases, focusing primarily on hematologic malignancies such as acute myeloid leukemia, chronic myeloid leukemia, acute T-cell lymphoblastic leukemia/lymphoma, and non-Hodgkin lymphoma. Sponsored by academic medical centers and pharmaceutical companies, these studies assess the compounds as monotherapies or in combination with agents like venetoclax or azacitidine. Recruitment statuses across these trials range from actively recruiting and completed to terminated or withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06855810 | RECRUITING | Acute Lymphoblastic Leukemia; Childhood Leukemia, Acute Lymphoblastic; T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma |
Institute of Hematology & Blood Diseases Hospital, China |
2025-03-11 | PHASE2; PHASE3 |
| NCT06221683 | RECRUITING | AML, Childhood; Acute Myeloid Leukemia |
Children's Hospital of Soochow University |
2024-01-01 | PHASE2 |
| NCT07131059 | RECRUITING | AML, Adult |
Institute of Hematology & Blood Diseases Hospital, China |
2024-05-11 | |
| NCT07507825 | NOT_YET_RECRUITING | Acute Myeloid Leukemia (AML) |
First People's Hospital of Hangzhou |
2026-03-31 | PHASE2 |
| NCT07469046 | NOT_YET_RECRUITING | Acute Myeloid Leukemia (AML); Elderly Patients (60-75 Years) |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
2026-04-10 | PHASE3 |
| NCT07505160 | NOT_YET_RECRUITING | Acute Myeloid Leukemia (AML) |
Second Affiliated Hospital, Zhejiang University, School of Medicine |
2026-03 | PHASE2 |
| NCT06265545 | RECRUITING | AML; Refractory; Relapsed |
Institute of Hematology & Blood Diseases Hospital, China |
2024-02-22 | |
| NCT06744556 | ACTIVE_NOT_RECRUITING | AML |
Institute of Hematology & Blood Diseases Hospital, China |
2025-01-21 | PHASE2 |
| NCT07163910 | RECRUITING | Prostate Cancer |
baotai Liang |
2025-04-20 | PHASE2 |
| NCT07159906 | NOT_YET_RECRUITING | Diffuse Large B-Cell Lymphoma; Relapsed Non-Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma |
First Affiliated Hospital of Zhejiang University |
2025-09-08 | PHASE1; PHASE2 |
| NCT06483906 | RECRUITING | Acute Myeloid Leukemia |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
2024-07-02 | PHASE2 |
| NCT06742463 | RECRUITING | Acute T Lymphpblastic Leukemia/Lymphoma |
First Affiliated Hospital of Zhejiang University |
2024-12 | PHASE2 |
| NCT06361329 | RECRUITING | ETP-ALL |
First Affiliated Hospital of Zhejiang University |
2024-04-03 | PHASE3 |
| NCT05906914 | COMPLETED | Acute Myeloid Leukemia, Adult |
First Affiliated Hospital of Zhejiang University |
2022-10-26 | PHASE2 |
| NCT05805098 | RECRUITING | Acute Myeloid Leukemia |
The First Affiliated Hospital of Soochow University |
2023-03-01 | PHASE2; PHASE3 |
| NCT05726110 | RECRUITING | Relapsed or Refractory Acute Myeloid Leukemia |
Shanxi Bethune Hospital |
2023-01-29 | PHASE3 |
| NCT04126681 | COMPLETED | Chronic Myeloid Leukemia, Chronic Phase |
Ascentage Pharma Group Inc. |
2019-10-21 | PHASE2 |
| NCT05805072 | UNKNOWN | Relapsed/Refractory AML |
The First Affiliated Hospital of Soochow University |
2023-05-01 | |
| NCT05513131 | UNKNOWN | Secondary Acute Myeloid Leukemia |
The First Affiliated Hospital with Nanjing Medical University |
2021-09-30 | PHASE2 |
| NCT04505995 | UNKNOWN | JMML |
Air Force Military Medical University, China |
2020-01-01 | |
| NCT05457361 | UNKNOWN | Venetoclax Combined With Azacitidine Plus Homoharringtonine; Venetoclax Combined With Azacitidine |
Nanfang Hospital, Southern Medical University |
2022-03-01 | PHASE3 |
| NCT04248595 | UNKNOWN | Acute Myeloid Leukemia |
Ge Zheng |
2019-12-01 | PHASE2 |
| NCT04083911 | UNKNOWN | Acute Myeloid Leukemia; Induction Chemotherapy |
The First Affiliated Hospital of Soochow University |
2019-04-01 | PHASE3 |
| NCT00375219 | COMPLETED | Chronic Myeloid Leukemia |
Teva Branded Pharmaceutical Products R&D, Inc. |
2006-09-20 | PHASE2 |
| NCT00462943 | COMPLETED | Chronic Myeloid Leukemia |
Teva Branded Pharmaceutical Products R&D, Inc. |
2007-03-07 | PHASE2 |
| NCT00675350 | COMPLETED | Hematologic Tumors |
ChemGenex Pharmaceuticals |
2008-04 | PHASE1 |
| NCT00114959 | TERMINATED | Myeloid Leukemia, Chronic; Myeloid Leukemia, Chronic, Accelerated-Phase; Blast Phase; Myeloid Leukemia, Chronic, Chronic-Phase |
ChemGenex Pharmaceuticals |
2005-10 | PHASE2 |
| NCT00006364 | COMPLETED | Childhood Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia; Relapsing Chronic Myelogenous Leukemia |
National Cancer Institute (NCI) |
1999-11 | PHASE2 |
| NCT00003694 | COMPLETED | Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia |
National Cancer Institute (NCI) |
1999-03 | PHASE2 |
| NCT00003239 | COMPLETED | Leukemia |
M.D. Anderson Cancer Center |
1998-03 | PHASE2 |
| NCT00002574 | COMPLETED | Leukemia |
National Cancer Institute (NCI) |
1994-09 | PHASE2 |
| NCT00004933 | TERMINATED | Leukemia |
Alliance for Clinical Trials in Oncology |
2000-01 | PHASE3 |
| NCT00030355 | WITHDRAWN | Leukemia |
National Cancer Institute (NCI) |
PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2025-08-26)
Check the
Harringtonine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.