Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
NCT ID: NCT04922567
Last Updated: 2022-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
289 participants
INTERVENTIONAL
2021-04-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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lenalidomide + CHOP regimen
Lenalidomide
25mg po on day 1-10
Cyclophosphamide
750mg/m² iv on day1
Doxorubicin
50mg/m² iv on day 1
Vincristine
1.4mg/m² iv on day 1
Prednisone
100mg po on day1-5
CHOP regimen
Cyclophosphamide
750mg/m² iv on day1
Doxorubicin
50mg/m² iv on day 1
Vincristine
1.4mg/m² iv on day 1
Prednisone
100mg po on day1-5
Interventions
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Lenalidomide
25mg po on day 1-10
Cyclophosphamide
750mg/m² iv on day1
Doxorubicin
50mg/m² iv on day 1
Vincristine
1.4mg/m² iv on day 1
Prednisone
100mg po on day1-5
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Xinqiao Hospital of Chongqing
OTHER
Union hospital of Fujian Medical University
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Southern Medical University, China
OTHER
Shandong Provincial Hospital
OTHER_GOV
Huashan Hospital
OTHER
First Hospital of China Medical University
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Henan Provincial People's Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Changhai Hospital
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
RenJi Hospital
OTHER
Zhongda Hospital
OTHER
The First Affiliated Hospital of Anhui Medical University
OTHER
Hunan Cancer Hospital
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
Jilin Provincial Tumor Hospital
OTHER
Shanxi Province Cancer Hospital
OTHER
Zhongshan Hospital Xiamen University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IR2020002513
Identifier Type: -
Identifier Source: org_study_id
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