Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT04922567

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-11-07

289

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

R

Ruijin Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

  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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

W

Wenbin Qian, Prof.

CONTACT

X

Xianggui Yuan, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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