NCT04922567 Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
| NCT ID | NCT04922567 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Peripheral T-Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 289 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 289 participants in total. It began in 2021-04-01 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04922567 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Peripheral T-Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04922567 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04922567 currently recruiting?
Yes, NCT04922567 is actively recruiting participants. Contact the research team at qianwb@zju.edu.cn for enrollment information.
Where is the NCT04922567 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04922567 clinical trial?
NCT04922567 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 289 participants.