A multicenter, randomized controlled trial of tamibarotene (OMS0728) in relapsed or refractory acute promyelocytic leukemia (APL).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15005943

Enrollment

Unknown

Registered

2015-02-04

Start date

2011-02-17

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed or refractory acute promyelocytic leukemia

Interventions

Trial Group:Tamibarotene with ATO

Control Group:ATRA with ATO

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. To be aged 18 to 75 years; 2. Relapsed or refractory APL; 3. PS =2;Not have severe non-controlled pulmonary or cardiac disease;total cholesterol and triglyceride results are not more than CTCAE Grade 2(CTCAE ver. 4.0,total cholesterol=10.34 mmol/L; triglyceride=5.7 mmol/L); white blood cells (WBC)<30,000/L; 4. Women who are pregnant are excluded, and can’t pregnant during clinical trial period and within 2years after end of use OMS0728; 5. Male patients must contracept during clinical trial period and within 6 months after end of use OMS0728; 6. Voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with central nervous system leukemia; 2. Patients who are taking Vitamin A or have Hypervitaminosis; 3. Patients who accepted cytotoxic drug which may affect the efficacy evaluation, for example, antharcycline or anthraquinones or Homoharringtonine(HHT); 4. Patients with Myelodysplastic syndrome history, or Acute leukemia unclassified; 5. Patients have active malignancy except APL; 6. Patients with uncontrollable systemic infectious diseases; 7. Patients with Acute or chronic liver or kidney disease(not caused by APL); 8. Patients with gastrointestinal dysfunction which will effect OMS0728 or ATRA absorption; 9. Women who are either pregnant or breast feeding, or of child-bearing potential; 10. Patients concomitant severe psychiatric disorder; 11. Patients with signs of toxicity from previous treatment; 12. Patients who had received Allogeneic Hematopoietic stem cell Transplantation; 13. Unsuitable patients considered by researchers.

Design outcomes

Primary

Measure	Time frame
CR rate;	—

Secondary

Measure	Time frame
CRi rate;CRc rate;CRm rate;PR rate;Days of CR;Relapse-Free Survival;Event-Free Survival;	—

Countries

China

Contacts

Public ContactWang Jianxiang

wangjx@ihcams.ac.cn+86 13821389157

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026