Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

Recruiting now · Phase 2

Conditions studied: Peripheral T-Cell Lymphoma, Lenalidomide, CHOP

In brief

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)

Key facts

Study ID: NCT04922567
Run by: Second Affiliated Hospital, Zhejiang University, School of Medicine
People needed: 289
Starts: 2021-04-01
Expected to finish: 2026-12-31
Last updated by the study team: 2022-11-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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