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Prospective phase III multicenter randomized controlled trial to improve the treatment of early extranodal nasal NK/T cell lymphoma

Prospective phase III multicenter randomized controlled trial to improve the treatment of early extranodal nasal NK/T cell lymphoma

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031889
Enrollment
Unknown
Registered
2020-04-13
Start date
2018-08-01
Completion date
Unknown
Last updated
2020-04-20

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

Conditions

Extranodal nasal type of NK/T cell lymphoma

Interventions

A:Imed-p-asp/gdp-p-asp alternative program
B:IMED-P-asp
C:IMED-P-asp

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) between the ages of 18 and 80 years; 2) untreated patients with extra-nodal NK/T cell lymphoma confirmed by histological examination; 3) there are measurable and evaluable lymphoma lesions for efficacy evaluation; 4) patients with Ann Arbor stage I and II; 5) not receiving any anti-tumor treatment; 6) normal blood routine, liver and kidney function (WBC>=3.5x10^9/L, Hb >100 g/L, PLT > 90x10^12/L); 7) the performance status of ECOG is 0-3;Life expectancy greater than 3 months; 8) no history of other malignant tumors; 9) no other serious diseases in conflict with the program; 10) no other antitumor concomitant treatment (including steroid drugs); 11) understand and are willing to participate in this clinical trial and provide a signed informed consent; 12) all patients must agree to use effective contraception during the study period and within 6 months after discontinuation of treatment. Female patients of childbearing age must have negative urine pregnancy test before treatment.

Exclusion criteria

Exclusion criteria: 1) participated in other clinical studies within the last 3 months; 2) secondary lymphoma after chemotherapy or radiotherapy for other malignant tumors; 3) transformed lymphoma; 4) Ann Arbor stage III-IV patients 5) received treatment for lymphoma before enrollment; 6) any other history of malignancy; 7) neutrophil count 2.0mg/dl); 12) clinical symptoms of brain dysfunction and serious mental illness; 13) lactating or pregnant women.

Design outcomes

Primary

MeasureTime frame
five-year survival rate;

Countries

China

Contacts

Public ContactLin Tongyu

Sun Yat-Sen University Cancer Center

tongyulin@hotmail.com+86 020 87343088

Outcome results

None listed

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