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New treatment option for New Diagnosed Angioimmunoblastic T-Cell Lymphoma
Official title Tislelizumab , Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL
ClinicalTrials.gov ID: NCT07168317
What this study is testing
What is tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone?
tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone is an investigational medicine, being studied as a potential treatment for new diagnosed angioimmunoblastic 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
- Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate.
- 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 diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016...
- Never received systemic or local treatment including chemotherapy before;
- Age ≥18 years old, male or female, ECOGPS≤3 points;
- Life expectancy exceeds 3 months;
- Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up.
You likely can't join if
- people who meet any of the following criteria are not eligible for inclusion in this study:
- Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or alanine aminotransferase...
- Bone marrow failure, specifically defined as absolute neutrophil count (ANC)\<1.5\ 10\^9/L or platelets \<75\ 10\^9/L or Hb\<90g/L, unless changes in...
- Patients who have previously received local or systemic anti-tumor treatment;
- Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction \ 450 ms for men,\>470 ms for women), ventricular...
- AIDS, syphilis, active B (HBV DNA\>1\ 10\^4 copies/ml) and hepatitis C;
See the full eligibility criteria
- Pathological diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014...
- Never received systemic or local treatment including chemotherapy before;
- Age ≥18 years old, male or female, ECOGPS≤3 points;
- Life expectancy exceeds 3 months;
- Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up.
- people who meet any of the following criteria are not eligible for inclusion in this study:
- Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or alanine aminotransferase, aspartate aminotransferase and serum creatinine\>2 times normal values...
- Bone marrow failure, specifically defined as absolute neutrophil count (ANC)\<1.5\ 10\^9/L or platelets \<75\ 10\^9/L or Hb\<90g/L, unless changes in hemogram are considered to be associated with lymphoma infiltration...
- Patients who have previously received local or systemic anti-tumor treatment;
- Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction \ 450 ms for men,\>470 ms for women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, symptomatic...
- AIDS, syphilis, active B (HBV DNA\>1\ 10\^4 copies/ml) and hepatitis C;
- Patients with other malignancies that are not effectively controlled; or with other hematological disorders (e.g. hemophilia, myelofibrosis, etc.), the investigator considers that the patient is not suitable for...
- History of autoimmune disease, receiving immunosuppressive therapy before enrollment, immunosuppressive dose\>10 mg/day or oral prednisone for more than 2 weeks;
- Clinically uncontrolled active infection (including bacterial, fungal or viral infections), and drug therapy is ineffective;
- Patients with uncontrolled hemophagocytic syndrome;
- Patients who have received secondary surgery or above within 3 weeks before treatment;
- Patients who have participated in clinical trials of other drugs within 30 days before enrollment or are participating in clinical trials of other new drugs;
- Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- Known allergies to investigational drug components;
- The investigator considers that the enrollment is not suitable.
The study team makes the final eligibility decision.
Where it's taking place
- Xuzhou, 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 Xuzhou, 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.