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

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.

Study Overview

• Status: Unknown
• Conditions: Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
• Intervention / Treatment: Other: chemotherapy followed by radiotherapy; Other: radiotherapy followed by chemotherapy; Drug: IPGDP regimen chemotherapy

Detailed 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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
  • Nanning, China
    • Recruiting
    • People's Hospital of Guangxi
    • Contact: Jiaxin Chen
  • Shijiazhuang, China
    • Recruiting
    • Fourth Hospital of Hebei Medical University
    • Contact: Yuhuan Gao
  • Taiyuan, China
    • Recruiting
    • Shanxi Province Cancer Hospital
    • Contact: Liping Su
  • Taiyuan, China
    • Recruiting
    • Shanxi Dayi Hospital
    • Contact: Qiaohua Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: chemotherapy followed by radiotherapy; 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.	Other: chemotherapy followed by radiotherapy
Other: radiotherapy followed by chemotherapy; 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.	Other: radiotherapy followed by chemotherapy
Other: IPGDP regimen chemotherapy; 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. 6 cycles, every 3 weeks one cycle.	Drug: IPGDP regimen chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell
• Other Study ID Numbers: CH-LYM-005