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Clinical Trial of Therapy with Thalidomide?Interferon and Interleukin-2 in Refractory/relapsed and Elderly Acute Myeloid Leukemia

Clinical Trial of Therapy with Thalidomide?Interferon and Interleukin-2 in Refractory/relapsed and Elderly Acute Myeloid Leukemia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-14004688
Enrollment
Unknown
Registered
2014-05-23
Start date
2014-06-01
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

refractory/relapsed and elderly acute myeloid leukemia

Interventions

Test Group:thalidomide,interferon,interleukin-2

Sponsors

The Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 18 to 80 years of age; (2)male and female; (3)diagnosed refractory/relapsed and elderly acute myeloid leukemia (>60 years old) and exclude APL; (4)no limit to previous therapy(5)cardiac function NYHA class45%,antharcyclines cumulative dose less than 240mg/m2 (6) STB=1.5×institutional upper limit of normal (ULN),ALT, AST=2.5×ULN (7) BUN,SCr?2.5×ULN (8) without other malignancy,or severe infection; (9) ECOG performance status ?2; (10) expected survival time>3 months; (11) signed informed consent.

Exclusion criteria

Exclusion criteria: (1) not diagnosed refractory/relapsed and elderly acute myeloid leukemia; (2)serious allergy to thalidomide,interferon or interleukin-2 with clinical manifestation of anaphylactic shock and laryngeal edema; (3) pregnancy or nursing; (4) suffered with malignancy in addition to NHL,severe infection or central nervous system AML; (5) have significant heart disease activity within the previous 6 months:MI,class ?-? congestive heart failure according to NYHA,unstable ungina,unstable pericardiac disease and cardiac amyloidosis; (6) ?2 peripheral neuropathy according to NCTCTCAE 4.0; (7) ALT,AST?2.5×ULN,STB?1.5×ULN; (8) lung function decompensation; (9) renal failure; (10) psychotic episodes.

Design outcomes

Primary

MeasureTime frame
overall response rate;complete remission;part remissio;

Secondary

MeasureTime frame
Progress-free survival;overall surviva;

Contacts

Public ContactWei XuDong
weixudong63@126.com+86 13837169301

Outcome results

None listed

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