Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02560441
Other study ID # CH-LYM-005
Secondary ID
Status Recruiting
Phase Phase 2
First received September 11, 2015
Last updated January 1, 2018
Start date September 2015

Study information

Verified date January 2018
Source Chinese Academy of Medical Sciences
Contact Yuankai Shi
Phone 87788293
Email syuankaipumc@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The first Part: Patients in IPGDP regimen chemotherapy followed by radiotherapy arm 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. Then patients undergo radiotherapy. If the disease is considered to progress or as stable during chemotherapy, the patient will directly receive radiotherapy. Patients in another arm receive radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both arms are 3 cycles, which is repeated every 3 weeks.

The second Part: Patients receive 6 cycles of 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. IPGDP regimen is repeated every 3 weeks. If the disease is considered to progress or as stable after 2 cycles or 4 cycles of chemotherapy, the patient will withdraw from this study.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
chemotherapy followed by radiotherapy

radiotherapy followed by chemotherapy

Drug:
IPGDP regimen chemotherapy


Locations

Country Name City State
China Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Beijing
China People's Hospital of Guangxi Nanning
China Fourth Hospital of Hebei Medical University Shijiazhuang
China Shanxi Dayi Hospital Taiyuan
China Shanxi Province Cancer Hospital Taiyuan

Sponsors (15)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences 307 Hospital of PLA, First Hospital of China Medical University, Guangdong General Hospital, Hebei Medical University Fourth Hospital, Nanfang Hospital of Southern Medical University, People's Hospital of Guangxi, Qilu Hospital of Shandong University, Shandong Cancer Hospital and Institute, Shanxi Dayi Hospital, Shanxi Province Cancer Hospital, The Second Affiliated Hospital of Dalian Medical University, Tianjin Medical University Cancer Institute and Hospital, Xuzhou Medical University, Zhangzhou Municipal Hospital of Fujian Province

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression-free survival 5 years
See also
  Status Clinical Trial Phase
Recruiting NCT04288726 - Allogeneic CD30.CAR-EBVSTs in Patients With Relapsed or Refractory CD30-Positive Lymphomas Phase 1
Withdrawn NCT04952584 - Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas Phase 1