Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
- Conditions
- CHOPPeripheral T-Cell LymphomaLenalidomide
- Interventions
- Registration Number
- NCT04922567
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 289
- 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).
- Males and females of 18 years of age to 80 years of age.
- Patients have not received anti-tumor therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- 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.
- Normal peripheral hemogram: absolute neutrophil count(ANC)≥1.5×10^9/L, hemoglobin(Hb)≥90g/L, platelet(PLT)≥100×10^12/L.
- None of other serious disease conflict with the therapeutic regimen.
- None of other malignant tumor.
- Pregnancy test of women at reproductive age must be negative.
- Estimated survival time ≥ 3 months with good compliance.
- Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.
- 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.
- Transformed lymphoma.
- Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.
- Already initiated lymphoma therapy (except for the prephase treatment specified for this study).
- Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.
- Patients who have central nervous system or meninges involvements.
- Candidate for hematopoietic stem cell transplantation.
- Known hypersensitivity to medications to be used.
- Hemogram abnormality: ANC<1.5×10^9/L; or hemoglobin<90 g/L; or PLT<100×10^9/L.
- Known hepatic and renal insufficiency (creatine>2.0×ULN, total bilirubin>2.0 mg/dl，transaminases>3.0×ULN).
- 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.
- Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.
- Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity.
- Pregnancy or lactation period.
- Patients who participated in other clinical trials within 3 months.
- The researchers considered that patients should not be in this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lenalidomide + CHOP regimen Vincristine - lenalidomide + CHOP regimen Cyclophosphamide - CHOP regimen Vincristine - lenalidomide + CHOP regimen Lenalidomide - lenalidomide + CHOP regimen Doxorubicin - lenalidomide + CHOP regimen Prednisone - CHOP regimen Cyclophosphamide - CHOP regimen Doxorubicin - CHOP regimen Prednisone -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China