CHOP, Lenalidomide, Peripheral T-Cell Lymphoma
Conditions
Brief summary
This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL)
Detailed description
This is a randomized, multi-center, open-label study to compare efficacy and safety of L-CHOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles or Lenalidomide plus CHOP (L-CHOP) administered in 3 week cycles for 6 cycles. In the L-CHOP arm, Lenalidomide will be administered at a dose of 25mg po on day 1-10 every 3 weeks. This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary with drawl. Adverse event of every treatment cycle will be recorded. Therapy efficacy will be evaluated after finishing 3 cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 3 years from the last patient randomized.
Interventions
DRUGLenalidomide
25mg po on day 1-10
DRUGCyclophosphamide
750mg/m² iv on day1
DRUGDoxorubicin
50mg/m² iv on day 1
DRUGVincristine
1.4mg/m² iv on day 1
DRUGPrednisone
100mg po on day1-5
Sponsors
Ruijin Hospital
Xinqiao Hospital of Chongqing
Union hospital of Fujian Medical University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Southern Medical University, China
Shandong Provincial Hospital
Huashan Hospital
First Hospital of China Medical University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Henan Provincial People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
Changhai Hospital
The Affiliated Hospital of Xuzhou Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RenJi Hospital
Zhongda Hospital
The First Affiliated Hospital of Anhui Medical University
Hunan Cancer Hospital
First Affiliated Hospital of Harbin Medical University
Xiangya Hospital of Central South University
The First Affiliated Hospital of Dalian Medical University
Jilin Provincial Tumor Hospital
Shanxi Province Cancer Hospital
Zhongshan Hospital Xiamen University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with T-follicular helper phenotype and Follicular T-cell lymphoma). 2. Males and females of 18 years of age to 80 years of age. 3. Patients have not received anti-tumor therapy. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 5. Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg/dl, transaminases≤3×ULN. 6. Normal peripheral hemogram: absolute neutrophil count(ANC)≥1.5×10\^9/L, hemoglobin(Hb)≥90g/L, platelet(PLT)≥100×10\^12/L. 7. None of other serious disease conflict with the therapeutic regimen. 8. None of other malignant tumor. 9. Pregnancy test of women at reproductive age must be negative. 10. Estimated survival time ≥ 3 months with good compliance. 11. Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.
Exclusion criteria
1. Patients with the following PTCL subtypes are excluded; extranodal natural killer(NK)/T-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, adult T-cell leukemia/ lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma. 2. Transformed lymphoma. 3. Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies. 4. Already initiated lymphoma therapy (except for the prephase treatment specified for this study). 5. Patients with primary central nervous system lymphoma or lymphoma involving central nervous system. 6. Patients who have central nervous system or meninges involvements. 7. Candidate for hematopoietic stem cell transplantation. 8. Known hypersensitivity to medications to be used. 9. Hemogram abnormality: ANC\<1.5×10\^9/L; or hemoglobin\<90 g/L; or PLT\<100×10\^9/L. 10. Known hepatic and renal insufficiency (creatine\>2.0×ULN, total bilirubin\>2.0 mg/dl，transaminases\>3.0×ULN). 11. Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months. 12. Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function. 13. Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity. 14. Pregnancy or lactation period. 15. Patients who participated in other clinical trials within 3 months. 16. The researchers considered that patients should not be in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response rate | At the end of Cycle 6 (each cycle is 21 days) | complete response (CR) and partial response (PR) rates, using the standard response criteria( 2014 Lugano criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 3 years | from date of inclusion to date of progression, relapse, or death from any cause |
| Overall Survival | 3 years | From the date of inclusion to date of death, irrespective of cause |
| Adverse Events | 3 years | Any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure |
Countries
China
Contacts
Primary ContactWenbin Qian, Prof.
Backup ContactXianggui Yuan, Dr.
Outcome results
None listed