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A prospective, phase III, multicenter, randomized trial for IMED-P/GDP-P chemotherapy for early stage extranodal NK/T cell lymphoma

A prospective, phase III, multicenter, randomized trial for IMED-P/GDP-P chemotherapy for early stage extranodal NK/T cell lymphoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018734
Enrollment
Unknown
Registered
2018-10-06
Start date
2018-12-01
Completion date
Unknown
Last updated
2018-10-10

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

Conditions

NK/T cell lymphoma, nasal type

Interventions

IMED-P/GDP-P:Receive sequential IMED-P/GDP-P chemotherapy for 6 cycles
IMED-P:Receive 6 cycles IMED-P chemotherapy
GDP-P:Receive 6 cycles GDP-P chemotherapy

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Aged 18-80 years; pathology confirmed extranodal NK/T cell lymphoma,nasal type; with measurable lymphoma lesions;Arbor stage I-II; Previously untreated; Adequate hematologic parameters and liver and kidney functions; ECOG 0-3;Estimated time of survival more than 3 months; Women of childbearing age with a negative pregnancy test; Give signed informed consent before enrollment.

Exclusion criteria

Exclusion criteria: Participated in other clinical trials in the last 3 months; Secondary or transforming lymphoma;Arbor stage III-IV; Previous malignancies; NEUT<1.0×10^9/L or HGB<80g/L or PLT<90×109/L; Active infection; Decompensated heart failure, dilated cardiomyopathy, an electrocardiogram showing ST segment depression and myocardial infarction in the last 6 months; Functional insufficiency of vital organs; clinical symptoms of brain dysfunction, severe mental illness; pregnant or lactating women; With history of other malignant tumors; With other serious diseases that conflict with this study.

Design outcomes

Primary

MeasureTime frame
5-year overall survial;

Secondary

MeasureTime frame
Objective Response Rate;complete remission rate;5-year progression-free survival;safety;

Countries

China

Contacts

Public ContactTongyu LIN

Sun Yat-sen University Cancer Center

tongyulin@hotmail.com+86 13926400320

Outcome results

None listed

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