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A Phase I/II Combination Study of Topotecan, Fludarabine, Cytosine Arabinoside and G-CSF (T-FLAG) Induction Therapy in Patients With Poor Prognosis AML, MDS and Relapsed/Refractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic Acid
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT00003619-Jul 28, 2026
NCT ID
NCT00003619
Status
COMPLETED
Phase
Phase 1/2
Sponsor
Drexel University College of Medicine
Executive brief
Investment-Ready Snapshot
The T-FLAG regimen, combining topotecan, fludarabine, cytarabine, and G-CSF, targets patients with poor prognosis acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and relapsed/refractory acute lymphocytic leukemia (ALL). Given the high unmet medical need in these indications, successful outcomes could position this therapy favorably in a competitive market, particularly against existing therapies such as standard chemotherapy and newer agents. The study's completion in 2004 suggests that further analysis of the results could inform potential licensing opportunities or partnerships for commercialization. The market for AML and MDS therapies is significant, with ongoing demand for innovative treatment options.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT00003619
Indication
Chronic Myeloproliferative Disorders
Modality
protein therapy
Target
Topotecan, Fludarabine, Cytarabine, and G-CSF (filgrastim) target various mechanisms of action in cancer cell proliferation and apoptosis, with a focus on hematological malignancies.
Intervention
filgrastim, vitamin E, busulfan, cytarabine, etoposide, fludarabine phosphate, isotretinoin, topotecan hydrochloride, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.