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Compares treatment options for Peripheral T-Cell Lymphoma
Official title Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
ClinicalTrials.gov ID: NCT04922567
What this study is testing
What is Lenalidomide?
Lenalidomide is an investigational medicine, being studied as a potential treatment for peripheral t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic 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...
You likely can't join if
- Patients with the following PTCL subtypes are excluded; extranodal natural killer(NK)/T-cell lymphoma, T-prolymphocytic leukemia, T large granular...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.