Clinical trial · Interventional
Trial of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
A Multicenter Phase II Trial to Evaluate the Safety and Efficacy of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
NCT02560441CI-TRIAL-00031004unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The first Part: recruiting untreated ENKL patients with extensive stage I or limited stage II disease (only referring to patients with the invasion of Waldeyer's ring and cervical lymph nodes) . Patients are randomly divided into two arms, IPGDP regimen chemotherapy followed by radiotherapy or radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both arms are 3 cycles. And the chemotherapy is repeated every 3 weeks.. The second part: recruiting extensive stage II ,stage III-IV, relapsed or refractory ENKL patients. Patients receive 6 cycles of IPGDP regimen chemotherapy. And the chemotherapy is repeated every 3 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy followed by radiotherapy | Other | — | UNRESOLVED |
| IPGDP regimen chemotherapy | Drug | — | UNRESOLVED |
| radiotherapy followed by chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- chemotherapy followed by radiotherapy
- description
- Patients receive 3 cycles of IPGDP (ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2 iv on days 3-6) chemotherapy followed by radiotherapy.
- interventionNames
- Other: chemotherapy followed by radiotherapy
- type
- OTHER
- label
- radiotherapy followed by chemotherapy
- description
- Patients receive radiotherapy followed by 3 cycles of IPGDP (ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2 iv on days 3-6) chemotherapy.
- interventionNames
- Other: radiotherapy followed by chemotherapy
- type
- OTHER
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * histologically proven diagnosis of Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type(ENKL) * untreated ENKL patients of extensive stage I and limited stage II ( only referring to patients with the invasion of Waldeyer's ring and neck lymph node) confirmed by imaging examination; extensive stage II ,stage III-IV, relapsed or refractory ENKL patients confirmed by imaging examination * age 18-65 years * at least one measurable lesions * Eastern Cooperative Oncology Group (ECOG) of 0 to 1 * a life expectancy of at least 12 weeks * Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) \>or equal to 1.5 \* 109/L, platelets \>or equal to 100 \*109/L, hemoglobin \> or equal to 9g/dL. Hepatic: bilirubin \< or equal to 2 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 2.5 x ULN (AST, ALT \< or equal to 5 x ULN is acceptable if liver has been involved). Renal: serum creatinine \< or equal to 1.5 x ULN. Coagulation function :activated partial thromboplastin time \< or equal to 1.5 x ULN, fibrinogen \> or equal to 0.75 times of the lower limit of the normal value, INR \< or equal to 1.5 x ULN. * informed consent signed by patients prior to commencement of the study * pregnancy test of Women of childbearing must be negative at the beginning of 7 days before treatment; surgical sterilization or taking contraceptive measures during treatment and three months after the end of treatment for males. Exclusion Criteria: * severe allergies to the investigational drugs * patients who had received unauthorized drugs or drugs of other trials within 4 weeks prior to the study * Severe or unstable systemic disease，serious neurological or psychiatric diseases including seizures or dementia * organ function including the following: Bone marrow: absolute neutrophil count (ANC) \< 1.5 \* 109/L, platelets\<100 \*109/L, hemoglobin \< 9g/dL. Hepatic: bilirubin \> 2 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) \>2.5 x ULN (AST, ALT \> 5 x ULN is acceptable if liver has been involved). Renal: serum creatinine \> 1.5 x ULN. Abnormal Coagulation function : such as activated partial thromboplastin time prolonged \> 1.5 x ULN, fibrinogen \< 0.75 times of the lower limit of the normal value, increased INR \> 1.5 x ULN any other important clinical or laboratory abnormalities that are not appropriate for research * Patients who had previously received treatment of this study, or withdrew from the study * receiving any other anti-tumor therapy at the same time * pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.