Teniposide has been evaluated across Phase 1 through Phase 4 clinical trials, investigating its efficacy as a monotherapy or within multi-agent chemoimmunotherapy regimens for conditions including acute lymphoblastic leukemia, primary central nervous system lymphoma, mantle cell lymphoma, and extensive-stage small-cell lung cancer. Sponsored by academic medical centers and research foundations, trial recruitment statuses range from completed historical studies to active, recruiting protocols testing modern combination approaches for hematologic and solid tumors.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07074470 | RECRUITING | Primary Central Nervous System Lymphoma (PCNSL) |
The First Affiliated Hospital of Soochow University |
2025-01-02 | |
| NCT07185373 | RECRUITING | Primary Central Nervous System Lymphoma |
Huashan Hospital |
2025-10-01 | PHASE2; PHASE3 |
| NCT07583511 | RECRUITING | Small-cell Lung Cancer |
Sun Yat-sen University |
2024-02-01 | PHASE2 |
| NCT07188441 | RECRUITING | GCT; Germ Cell Tumor; Central Malignant Germ Cell Tumor |
Chengcheng Guo |
2024-08-13 | PHASE2 |
| NCT06758700 | RECRUITING | Extensive-stage Small Cell Lung Cancer (ES-SCLC); Thoracic Neoplasms; Lung Neoplasms; Lung Diseases |
Shanghai Pulmonary Hospital, Shanghai, China |
2025-02-07 | PHASE2 |
| NCT06048107 | UNKNOWN | HLH |
Beijing Friendship Hospital |
2023-10-22 | |
| NCT01700946 | COMPLETED | Recurrent B-Cell Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood B-Lymphoblastic Lymphoma |
St. Jude Children's Research Hospital |
2013-04-15 | PHASE2 |
| NCT00186875 | COMPLETED | Acute Lymphoblastic Leukemia; Lymphoma, Lymphoblastic |
St. Jude Children's Research Hospital |
2003-11 | PHASE2 |
| NCT00853008 | COMPLETED | Acute Lymphoblastic Leukemia |
PETHEMA Foundation |
2003-01 | PHASE4 |
| NCT00198991 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Goethe University |
2003-04 | PHASE4 |
| NCT00004231 | COMPLETED | Lymphoma |
Northwestern University |
1999-10 | PHASE2 |
| NCT00187083 | COMPLETED | Acute Lymphoblastic Leukemia |
St. Jude Children's Research Hospital |
1997-02 | PHASE3 |
| NCT00004916 | COMPLETED | Lymphoma |
Northwestern University |
1999-02 | PHASE1; PHASE2 |
| NCT00002531 | UNKNOWN | Leukemia |
Johann Wolfgang Goethe University Hospital |
1993-01 | PHASE2 |
| NCT00343369 | UNKNOWN | Leukemia |
Universitätsklinikum Hamburg-Eppendorf |
2003-01 |
(data from https://clinicaltrials.gov, updated on 2025-07-20)
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>).