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Short-term combination of arsenic acid (ATO) and all trans retinoic acid (ATRA) in the treatment of acute promyelocytic leukemia: a phase 2 clinical trial

Short-term combination of arsenic acid (ATO) and all trans retinoic acid (ATRA) in the treatment of acute promyelocytic leukemia: a phase 2 clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16007972
Enrollment
Unknown
Registered
2016-02-22
Start date
2016-05-01
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

acute promyelocytic leukemia

Interventions

treatment arm:short-term combination of ATO and ATRA

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Men and women, aged between 18 to 75 years; 2. Subjects have diagnosed APL; 3. ECOG performance status (PS) score 0-2; 4. AST and ALT <=2.5 times the institutional ULN; Total bilirubin <=2.0 times the institutional ULN Serum creatinine<2.0 times the institutional ULN; 5. Women or men must take effective contraceptive measures, in women Serum or urine pregnancy tests must be negative in the screening and study periods; 6. Men must take effective contraceptive measures during or after treatment within 6 months; 7. Patients understand the disease and voluntarily received the study regimen and follow-up.

Exclusion criteria

Exclusion criteria: 1. History of tumors other than APL and received any treatment in 3 years, but exclusion superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (CIN), prostatic intraepithelial neoplasms(PIN); 2. Activity viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; 3. Concurrent autoimmune hemolytic anemia or immune thrombocytopenia; 4. Subjects suffered from the AIDSactivity hepatitis B or C virus; 5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent; 6. Have known to be allergic to any study drugs.

Design outcomes

Primary

MeasureTime frame
3-year leukemia-free survival rate;

Secondary

MeasureTime frame
3-year overall survival rate;

Countries

China

Contacts

Public ContactLu Yue
luyuesysucc@126.com+86 020 87342439

Outcome results

None listed

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