Comparing Lenalidomide with CHOP to CHOP alone for untreated Peripheral T-Cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the efficacy and safety of lenalidomide combined with the CHOP regimen against CHOP alone in patients with untreated peripheral T-cell lymphoma (PTCL). It is a randomized, multi-center, open-label trial where participants will receive either the standard CHOP treatment or the L-CHOP regimen over six cycles. The study includes a screening phase, treatment phase, and follow-up phase, with efficacy evaluated after three and six cycles. Adverse events will be monitored throughout the treatment duration.

Why it matters

Who can join: the full rules

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.

Where it's running

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Wenbin Qian, Prof.
• Email: qianwb@zju.edu.cn
• Phone: +86-13605801032

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.