Clinical trial · Interventional
Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia
A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Supporting agency withdrew funding for study.
Summary
Brief summary (as posted)
Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an investigational drug called Tamibarotene in combination with standard treatment for relapsed APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of this study is to determine if tamibarotene in combination with arsenic trioxide is safe and effective.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| Tamibarotene | Drug | Tamibarotene | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Tamibarotene + Arsenic Trioxide
- interventionNames
- Drug: Tamibarotene
- Drug: Arsenic trioxide
Primary outcomes (1)
- measure
- To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.
- timeFrame
- Once the MTD has been reached.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have diagnosis of relapsed APL * Must have completed any prior cancer treatment at least 6 months prior to study * Must have had prior treatment that included ATRA
References
Publications (0)
Data not yet available