Vindesine sulfate has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4, focusing primarily on solid tumors like lung cancer and hematological malignancies, including leukemia as well as T-cell non-Hodgkin's, follicular, and diffuse large-cell lymphomas. Sponsored by academic hospitals, collaborative oncology groups, and major institutions such as the National Cancer Institute, these investigations reflect varied recruitment statuses, including recruiting, active, completed, terminated, and not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04043494 | RECRUITING | Lymphoblastic Lymphoma, Childhood |
University Hospital Muenster |
2019-08-23 | PHASE3 |
| NCT07159620 | RECRUITING | Adult T-cell Leukemia/Lymphoma |
The First Affiliated Hospital of Soochow University |
2025-09-01 | PHASE2 |
| NCT03643276 | RECRUITING | Acute Lymphoblastic Leukemia, Pediatric |
Martin Schrappe |
2018-07-15 | PHASE3 |
| NCT06918015 | NOT_YET_RECRUITING | BTK Inhibitors; Follicular Lymphoma; Immunochemotherapy |
Zhejiang Cancer Hospital |
2025-05-01 | PHASE2 |
| NCT03206671 | ACTIVE_NOT_RECRUITING | Mature B-cell Non-Hodgkin Lymphoma |
University Hospital Muenster |
2017-08-03 | PHASE3 |
| NCT07004075 | NOT_YET_RECRUITING | Low-grade Glioma; Pediatric Low-grade Gliomas; pLGG With BRAF Alteration |
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. |
2025-06-30 | PHASE3 |
| NCT05681260 | RECRUITING | T-cell Lymphoblastic Lymphoma |
Children's Cancer Group, China |
2023-02-06 | PHASE3 |
| NCT04221035 | RECRUITING | High-Risk Neuroblastoma; Patient With Insufficient Response Chemoimmunotherapy |
Gustave Roussy, Cancer Campus, Grand Paris |
2019-11-05 | PHASE3 |
| NCT06361329 | RECRUITING | ETP-ALL |
First Affiliated Hospital of Zhejiang University |
2024-04-03 | PHASE3 |
| NCT06713057 | NOT_YET_RECRUITING | Locally Advanced Thyroid Gland Carcinoma; Thyroid Cancer |
West China Hospital |
2024-12-01 | PHASE2 |
| NCT06177132 | Not yet recruiting | Vestibular Disorder |
University Hospital Ghent|University Ghent |
2025-11 | Not Applicable |
| NCT05900765 | UNKNOWN | Classical Hodgkin Lymphoma |
Sun Yat-sen University |
2023-06-14 | PHASE2 |
| NCT02881086 | COMPLETED | Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma |
Goethe University |
2016-08 | PHASE3 |
| NCT06350669 | Not yet recruiting | Vestibular Disorder|Vestibular Diseases|Vestibular Abnormality |
University of Haifa|Sheba Medical Center|Ben-Gurion University of the Negev |
2024-06 | Not Applicable |
| NCT06305949 | Not yet recruiting | Deglutition Disorders |
NEUROPHET|Bucheon St. Mary''s Hospital|Saint Vincent''s Hospital Korea|National Traffic Injury Rehabilitation Hospital|Pusan National University Yangsan Hospital |
2024-04-01 | Not Applicable |
| NCT06187688 | Not yet recruiting | Postoperative Pain |
Prince of Songkla University |
2024-01 | -- |
| NCT05049473 | UNKNOWN | Mature B-Cell Leukemia Burkitt Type; Burkitt Lymphoma (BL); Unclassifiable Lymphoma Between DCBL and BL |
PETHEMA Foundation |
2014-01 | PHASE2 |
| NCT02845882 | ACTIVE_NOT_RECRUITING | Lymphoblastic Lymphoma |
Children's Cancer Group, China |
2016-01 | PHASE3 |
| NCT05777369 | UNKNOWN | Diffuse Large B-cell Lymphoma |
The First Affiliated Hospital with Nanjing Medical University |
2023-03 | |
| NCT04843267 | UNKNOWN | Hodgkin Lymphoma; Chemotherapy Effect |
Sun Yat-sen University |
2021-05-01 | PHASE2 |
| NCT04899570 | UNKNOWN | Intravascular Large B-Cell Lymphoma |
Peking Union Medical College Hospital |
2021-04-01 | PHASE2 |
| NCT01117441 | COMPLETED | Leukemia |
University Hospital Schleswig-Holstein |
2010-06 | PHASE3 |
| NCT02767674 | UNKNOWN | Diffuse Large B Cell Lymphoma |
The First Affiliated Hospital with Nanjing Medical University |
2016-05 | PHASE3 |
| NCT02987244 | UNKNOWN | T Cell Non-Hodgkin's Lymphoma |
Peking Union Medical College Hospital |
2016-03 | PHASE1; PHASE2 |
| NCT03018626 | UNKNOWN | Lymphoma, Large B-Cell, Diffuse |
Nanfang Hospital, Southern Medical University |
2017-07-27 | PHASE3 |
| NCT02871869 | UNKNOWN | Diffuse, Large B-Cell, Lymphoma |
Xinjiang Medical University |
2016-09 | PHASE2; PHASE3 |
| NCT01156883 | COMPLETED | Leukemia |
Gruppo Italiano Malattie EMatologiche dell'Adulto |
2010-04 | |
| NCT00526318 | UNKNOWN | Neuroblastoma |
German Society for Pediatric Oncology and Hematology GPOH gGmbH |
2007-01 | |
| NCT00920153 | TERMINATED | Lymphoma |
French Innovative Leukemia Organisation |
2008-05 | PHASE3 |
| NCT00317408 | UNKNOWN | Lymphoma |
European Inter-group Cooperation on Childhood and Adolescent Non Hodgkin Lymphoma |
2004-04 | |
| NCT00759824 | COMPLETED | Small Cell Lung Carcinoma |
European Lung Cancer Working Party |
2008-09 | PHASE2 |
| NCT00430118 | COMPLETED | Leukemia |
University Hospital Schleswig-Holstein |
2000-07 | PHASE3 |
| NCT00198991 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Goethe University |
2003-04 | PHASE4 |
| NCT00136565 | COMPLETED | Peripheral T-cell Lymphoma |
Lymphoma Study Association |
2006-01-08 | PHASE2 |
| NCT00410631 | UNKNOWN | Neuroblastoma |
German Society for Pediatric Oncology and Hematology GPOH gGmbH |
2004-10 | PHASE3 |
| NCT01458730 | COMPLETED | Central Nervous System Lymphoma |
University of Aarhus |
2007-05 | PHASE2 |
| NCT00199082 | COMPLETED | Burkitt's Lymphoma; Burkitt's Leukemia; Mediastinal Neoplasms; Lymphoblastic Lymphoma; Large Cell Anaplastic Lymphoma |
Nicola Goekbuget |
2002-07 | PHASE4 |
| NCT00135499 | TERMINATED | Lymphoma, Large-Cell, Diffuse |
Lymphoma Study Association |
2001-10-16 | PHASE3 |
| NCT00199004 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Johann Wolfgang Goethe University Hospital |
2004-04 | PHASE4 |
| NCT00199017 | COMPLETED | Lymphoma, Lymphoblastic |
Johann Wolfgang Goethe University Hospital |
2004-04 | PHASE4 |
| NCT00003728 | UNKNOWN | Leukemia; Lymphoma |
European Organisation for Research and Treatment of Cancer - EORTC |
1998-12 | PHASE3 |
| NCT00764907 | UNKNOWN | Leukemia |
University Hospital, Motol |
2002-11 | PHASE3 |
| NCT00613457 | COMPLETED | Leukemia |
Associazione Italiana Ematologia Oncologia Pediatrica |
2000-09 | PHASE3 |
| NCT00199056 | COMPLETED | Adult Acute Lymphocytic Leukemia |
Goethe University |
1999-10 | PHASE4 |
| NCT00002823 | COMPLETED | Lung Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
1995-02 | PHASE3 |
| NCT00003209 | COMPLETED | Cervical Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
1997-12 | PHASE3 |
| NCT00003240 | UNKNOWN | Lung Cancer |
National Cancer Institute (NCI) |
1995-10 | PHASE3 |
| NCT00002531 | UNKNOWN | Leukemia |
Johann Wolfgang Goethe University Hospital |
1993-01 | PHASE2 |
| NCT00002532 | UNKNOWN | Leukemia |
Hannover Medical School |
1993-01 | PHASE2 |
| NCT00128037 | COMPLETED | Pulmonary Neoplasm |
Japan Clinical Oncology Group |
1999-05 | PHASE2 |
| NCT00689845 | UNKNOWN | Lymphoma |
University Hospital Southampton NHS Foundation Trust |
2007-06 | |
| NCT00017225 | COMPLETED | Neuroblastoma |
German Society for Pediatric Oncology and Hematology GPOH gGmbH |
1997-05 | PHASE2 |
| NCT00226473 | UNKNOWN | Metastatic Melanoma |
Dermatologic Cooperative Oncology Group |
2001-09 | PHASE4 |
| NCT00002802 | COMPLETED | Neuroblastoma |
Children's Hospital Medical Center, Cincinnati |
1990-07 | PHASE3 |
| NCT00002887 | UNKNOWN | Lung Cancer |
Ottawa Regional Cancer Centre |
1995-07 | PHASE1 |
| NCT00144053 | COMPLETED | Lung Cancer |
West Japan Thoracic Oncology Group |
2001-04 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-05-06)
Check the
Vindesine sulfate
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.