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NCT00985530
A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia
Phase 1 trial testing Tamibarotene in Acute Promyelocytic Leukemia in 4 participants. Terminated before completion.
1 May 2011
Quick facts
| Lead sponsor | Northwestern University |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 1 October 2009 |
| Primary completion | 1 May 2011 |
| Estimated completion | 1 May 2011 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tamibarotene — full drug profile →
- Arsenic trioxide (ARSENIC TRIOXIDE) — full drug profile →
Conditions studied
- Acute Promyelocytic Leukemia — all drugs for Acute Promyelocytic Leukemia →
Sponsor
Northwestern University
Who can join
18 and older, any sex, with Acute Promyelocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.
Time frame: Once the MTD has been reached.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Retinoid receptor signaling and autophagy in acute promyelocytic leukemia.
Orfali N, McKenna SL, Cahill MR, Gudas LJ, et al · · 2014 · cited 36× · PMID 24694321 · DOI 10.1016/j.yexcr.2014.03.018 -
Emerging new approaches for the treatment of acute promyelocytic leukemia.
Park J, Jurcic JG, Rosenblat T, Tallman MS. · · 2011 · cited 13× · PMID 23556100 · DOI 10.1177/2040620711410773
Verify or expand the search:
- PubMed search for NCT00985530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tamibarotene
Trials testing the same drug.
- NCT06085638 — Phase I/II Study of SY-1425 (Tamibarotene) in Combination With Azacitidine and Venetoclax for Patients With Chronic Myel · Phase 1, PHASE2 · withdrawn
- NCT04905407 — Tamibarotene Plus Venetoclax/Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) · Phase 2 · terminated
- NCT04797780 — Tamibarotene Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome · Phase 3 · terminated
- NCT02807558 — A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplas · Phase 2 · completed
Other recruiting trials for Acute Promyelocytic Leukemia
Currently open trials in the same condition.
- NCT05832320 — Optimum Induction Therapy of Low-risk APL · NA · recruiting
- NCT04687176 — Frontline Oral Arsenic Trioxide for APL · Phase 2 · recruiting
- NCT04793919 — Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia · Phase 2 · recruiting
Other Northwestern University trials
Trials by the same sponsor.
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- NCT07392775 — ALDH2 Genetic Testing in East Asian Community · NA · not yet recruiting
- NCT06886776 — Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Ill · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00985530 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Northwestern University
- Last refreshed: 28 October 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00985530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing