BridgeMD
New treatment option for Relapsed/Refractory Peripheral T-cell Lymphoma
Official title Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma
ClinicalTrials.gov ID: NCT05182957
What this study is testing
What is Anti-PD-1 monoclonal antibody?
Anti-PD-1 monoclonal antibody is an investigational medicine, being studied as a potential treatment for relapsed/refractory peripheral t-cell lymphoma.
Also referred to as Anti-PD-1 antibody.
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
- Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathological immunohistochemistry or flow cytometry confirmed that R/R PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the...
- Age ≥ 18 years.
- ECOG≤2分.
- The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70\ 1012/L，PLT≥50\ 109/L，NE≥1\ 109/L；LVEF≥50%;CR≤132umol/l...
- people of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the...
You likely can't join if
- Accepted major surgery within 4 weeks before treatment.
- Prior malignancy (other than Relapsed/Refractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3...
- Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.
- Have stroke or intracranial hemorrhage within 3 months.
- Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at...
- HIV infection and/or active hepatitis B or active hepatitis C.
See the full eligibility criteria
- Pathological immunohistochemistry or flow cytometry confirmed that R/R PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1\> After 4 courses of standard first-line therapy...
- Age ≥ 18 years.
- ECOG≤2分.
- The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70\ 1012/L，PLT≥50\ 109/L，NE≥1\ 109/L；LVEF≥50%;CR≤132umol/l or CCr≥60 ml/min;ALT and AST≤2 times normal range；Lung function≤Level...
- people of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.
- Estimated survival time ≥3 months.
- Voluntary signing of informed consent.
- Accepted major surgery within 4 weeks before treatment.
- Prior malignancy (other than Relapsed/Refractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin...
- Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.
- Have stroke or intracranial hemorrhage within 3 months.
- Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac...
- HIV infection and/or active hepatitis B or active hepatitis C.
- Uncontrolled systemic infection.
- Pregnant or breasting-feeding women.
- According to the researchers' judgment, any life-threatening disease, medical condition or organ system dysfunction which can endanger the patient's safety and Interfer with the absorption or metabolism of anti-PD-1...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, 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.